Kornimate/medical-research-clean huggingface dataset:
a phase 1b/2 study of adg116, adg116 combined with anti-pd-1 antibody or anti-cd137 antibody in solid tumors patients

Conditions: Advanced/Metastatic Solid Tumors

Summary: this is a phase 1, open-label, dose escalation study in patients with advanced/metastatic solid tumors. study drug, adg116, is an anti -ctla-4 fully human monoclonal antibody that specifically binds to human ctla-4. adg106, a fully human ligand-blocking agonistic anti-cd137 igg4 mab, is expected to enhance the activity of activated t cells. the enhanced antitumor efficacy results observed from the preclinical studies of adg116 in combination with adg106 or anti-pd-1 provided further support to explore such combinations in clinical settings for better patient responses.


Eligibility criteria:
inclusion criteria: patients must meet all of the following inclusion criteria to be eligible for participation in this study: 1. ≥ 18 years of age at the time of informed consent. 2. eastern cooperative oncology group (ecog) performance status 0 or 1. 3. patients with advanced or metastatic solid tumors, who have progressed after all standard therapies, or for whom no further standard therapy exists. 4. at least 1 measurable lesion at baseline according to the definition of recist v1.1. 5. adequate organ function. exclusion criteria: • patients who meet any of the following criteria cannot be enrolled: 1. pregnant or breastfeeding females. 2. childbearing potential who does not agree to the use of contraception during the treatment period.. 3. treatment with any investigational drug within washout period. 4. grade ≥ 3 immune-related aes (iraes) or irae that lead to discontinuation of prior immunotherapy. 5. central nervous system disease involvement 6. history or risk of autoimmune disease. 7. history of life-threatening hypersensitivity or known to be allergic to protein drugs or recombinant proteins or any ingredients contained in the adg116 drug formulation. 8. patients requiring systemic treatment with corticosteroids 9. patients receiving granulocyte colony stimulating factor (g-csf), within 14 days prior to the first dose of the study drug. 10. any uncontrolled active infections requiring systemic antimicrobial treatment (viral, bacterial, or other), or uncontrolled or poorly controlled, asthma, chronic obstructive pulmonary disease (copd). 11. major surgery within 4 weeks prior to the first dose of the study drug. 12. has had an allogeneic tissue/solid organ transplant.

Keywords: advanced/metastatic solid tumors
open label study to collect clinical data to document clinical performance and safety in total knee arthroplasty

Conditions: Total Knee Arthroplasty; Knee Disease; Total Knee Replacement; Osteo Arthritis Knee

Summary: the purpose of this study is to evaluate clinical performance and safety in total knee arthroplasty using hls implants.

it is planned to collect prospective and retrospective data from a continuous and exhaustive series of patients in a french center where total knee arthroplasty with hls prosthesis is performed routinely. all patients treated with hls kneetec (cemented, non-cemented or hybrid versions) implant will be included. all eligible patients seen in consultation and who agree to participate in the study should be included, systematically and consecutively, since the initiation of the study. data will be collected retrospectively for hls i, ii, evolution and noetos® implants, and when prospectively for cementless, cemented and hybrid hls kneetec prosthesis. post-surgery visit data will be collected at 1-y , 3-y , 5-y, 10-y fu visits per protocol then up to the latest fu visit available.

Eligibility criteria:
inclusion criteria: * for the hls-1, hls-2, hls evolution and hls noetos retrospective group: 1. adult patients older than 18 years old. 2. patients who have undergone routine preoperative clinical evaluations prior to their total knee replacement surgery and implanted with one of the following prostheses from the hls range: hls-1, hls-2, hls evolution and hls noetos between their first date of use in 1987 and their last date of use as normal practice at the participating site in accordance to indications and intended use as described in the instruction for use (ifu) of the study devices. 3. patients who have been informed about their participation into an observational study. for the hls kneetec prospective group (with retrospective surgeries): 1. adult patients older than 18 years old. 2. patients who have undergone routine preoperative clinical evaluations and received a tkr or are suitable candidates for a tkr with a fixed or mobile postero-stabilized hls kneetec prosthesis (cementless, cemented or hybrid combination) for the treatment of a primary or secondary knee osteoarthritis and inflammatory disease such as rheumatoid arthritis in accordance to indications and intended use as described in the instruction for use (ifu) of the study devices. 3. patients who are willing and able to complete the scheduled fu visits. 4. patients who have been informed about their participation into an observational registry study exclusion criteria: * patients mentally incompetent or unable to understand what participation in the study entails. * patients who present signs and symptoms of any of the known contraindications described in the instruction for use (ifu) of the study devices. * patients who deny their participation into the study.

Keywords: knee arthroplasty prosthesis implants hls implants postero-stabilized prosthesis third condyle arthroplasty
informed implementation of breast density reporting

Conditions: Breast Density, Breast Cancer Prevention

Summary: 1. to develop brief informational videos, vidscrips, that can be sent to women following their mammogram to provide personalized information that integrates breast density with overall breast cancer risk, and provides information about additional care recommendations and talking tips for conversations with the health care providers. 2. to test the effectiveness of this tool in a trial of 300 women undergoing mammography. the investigators hypothesize that individuals in the intervention arm (vs. those in the standard care arm who receive a letter with the language required by the legislation) will have more accurate knowledge of their overall risk of breast cancer, their mammographic breast density (mbd) result, more appropriate observed and intended use of additional screening \[i.e., use of screening magnetic resonance imaging (mri) will be reserved only for women at high risk of breast cancer\], better satisfaction with their episode of breast cancer screening, less decisional conflict about their personal decision for any additional evaluation, and less worry about breast cancer.


Eligibility criteria:
inclusion criteria: * undergoing screening mammography at participating hospital facility * normal mammogram result * no prior history of ductal carcinoma in situ (dcis) or invasive breast cancer * must have email account exclusion criteria: * non-english speaking * prior history of ductal carcinoma in situ (dcis) or invasive breast cancer * no email
noninvasive 3d mapping in persistent atrial fibrillation, to describe modifications of the arrhythmogenic substrate after pulmonary vein isolation and identify potential predicting factors of ablation success

Conditions: Atrial Fibrillation, Persistent

Summary: atrial fibrillation (af) is the most common cardiac arrhythmia in adults. it is a major cause of ischemic stroke and heart failure. intravascular cardiac ablation of the left atrium by catheter delivery is an efficient treatment to restore sinus rhythm. af ablation is a class iia treatment for patients with symptomatic persistent af refractory or intolerant to antiarrhythmic medication. there are still many debates considering the ablation strategy. the pulmonary veins remain the cornerstone of af ablation therapy, even in persistent af. there is a large electrical remodeling occurring in the left atrium between paroxysmal af, early persistent af and long-standing persistent af. however, no multicentric and randomized study has demonstrated so far the interest of targeting other left atrial substrate, such as rotors or focal sources. our study aims to describe with a noninvasive mapping system the arrhythmogenic substrate of persistent af \> 6 months pre- and post-cardioversion, and after pulmonary vein isolation.


Eligibility criteria:
inclusion criteria: 1. patients with documented persistent atrial fibrillation lasting longer than 6 months documented by 24h holter monitoring 2. age between 18 and 75 years 3. efficient oral anticoagulation during at least 1 month before the procedure 4. social security affiliation 5. feasible patient follow-up 6. patient willing to comply with study requirements and give informed consent to participate in this clinical study 7. indication for pulmonary vein isolation exclusion criteria: 1. previous atrial fibrillation ablation 2. previous left atrial ablation or surgery 3. atrial fibrillation without spontaneous rr interval \> 1000ms and with lvef \< 35% (measured by tte) 4. presence of a mechanical mitral valve 5. current intracardiac thrombus 6. any condition contraindicating chronic anticoagulation 7. uncontrolled hyperthyroidism 8. anteroposterior la diameter \> 55 mm measured by tte 9. body mass index ≥ 40 kg/m2

Keywords: pulmonary vein isolation cardioversion
study to monitor the safety and reactogenicity of fluarix™ in korean subjects aged > 6 months of age.

Conditions: Influenza

Summary: the present study collects data on safety and reactogenicity of the vaccine in the local target population (600 or more subjects) as per the requirement of korean food and drugs administration (kfda).


Eligibility criteria:
inclusion criteria: * a male or female \> 6 months of age at the time of the first vaccination. * subjects who the investigator believes that they and/or their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study. * free of obvious health problems as established by medical history and clinical examination judged by the investigator before entering into the study. * if the subject is female, she must be of non-childbearing potential, or, if of childbearing potential, she must be abstinent or have used adequate contraceptive precautions for 30 days prior to vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after vaccination. exclusion criteria: * clinical signs of acute febrile illness at the time of entry into the study. * any treatment with immunosuppressive drugs, including oral and parenteral corticosteroids. * history of allergic disease or reactions likely to be exacerbated by any component of the vaccine or previous severe reaction to influenza virus vaccine.

Keywords: influenza korea fluarixtm
the effect of hypertension medications on renal blood flow measurements in healthy males (mk-0000-127)

Conditions: Hypertension

Summary: this study will evaluate the effect of aliskiren and losartan on renal blood flow using pah clearance, pc mra and asl mri methodologies.


Eligibility criteria:
inclusion criteria: * subject is in generally good health * subject is willing to avoid unaccustomed strenuous exercise during the study * subject agrees to consume only the study-specified diet during all domiciled periods * subject has been a non-smoker for at least 3 months prior to study * subject will refrain from smoking or using any tobacco products during the study * subject agrees to refrain from consuming alcohol or caffeine during the domiciled periods and agrees to limit alcohol and caffeine consumption throughout the study exclusion criteria: * subject has contraindication to mri scans * subject has a history of stroke, seizure, or major neurological disorders * subject uses illicit drugs or has a history of drug/alcohol abuse * subject has had major surgery, has donated or lost 1 unit of blood, or has been in another investigational study in the last 4 weeks * subject has a history of multiple and/or severe allergies to drugs or food
study to assess pegloticase (krystexxa®) in patients on hemodialysis

Conditions: Chronic Kidney Disease Stage 5

Summary: this is a phase 1 single dose study conducted to evaluate the pk and pd of pegloticase administered to hemodialysis patients. a single dose of pegloticase will be administered intravenously to male or female hemodialysis patients (n = 12) starting 3 hour prior to dialysis. the study consists of a screening period, a treatment period, and follow up period.

end stage renal disease (esrd) patients that require hemodialysis typically undergo hemodialysis treatment 3 times per week. as such, medications can be dialyzed off, reducing their clinical effectiveness; this study is being conducted to understand how dialysis affects the pharmacokinetics (pk) and pharmacodynamics (pd) of pegloticase.

Eligibility criteria:
inclusion criteria: 1. 18 and 75 years of age, inclusive 2. agrees to employ best possible methods to abstain from becoming pregnant or impregnating another. 3. stage v chronic kidney patients with minimal or no residual renal function receiving hemodialysis and stable on hemodialysis (3x week) 4. bmi = 18.5 kg/m2 to \< 45 kg/m2 exclusion criteria: 1. any surgical or medical condition that may interfere with drug absorption, distribution, metabolism, or excretion, or any other condition that may place the subject at risk 1. glucose-6-phosphate dehydrogenase (g6pd) deficiency 2. uncontrolled congestive heart failure 3. refractory chronic gout 2. history of drug and/or alcohol abuse within 6 months prior to screening 3. history of or current clinically significant mental disorder or an antagonistic personality that compromises the validity of the informed consent 4. donation of blood or plasma within 30 days prior to dosing 5. history of or current hepatitis, or carriers of hepatitis b surface antigen (hbsag) and/or hepatitis c antibodies (anti-hc). 6. use of an investigational drug or product, within 30 days 7. history of clinically significant drug allergies or sensitivities 8. females with a positive pregnancy test or who are breast feeding at screening or plan to breast feed within 30 days of dosing 9. a baseline qtc interval ≥ 490 milliseconds for males and ≥ 510 milliseconds for females 10. is unable to refrain from alcohol 11. has taken any prescription or over the counter medication within 7 days prior to treatment day that, in the opinion of the investigator, could be expected to confound the pk or metabolism of the study drug 12. has taken the following herbal agents or nutraceuticals within 7 days prior to screening: chapparal, comfrey, germander, gin bu huan, kava, pennyroyal, skullcap, st. john's wort, or valerian 13. has poorly controlled malignant hypertension (systolic blood pressure \[sbp\] \> 200 mm hg and/or diastolic blood pressure \[dbp\] \> 120 mm hg, 14. concurrent use of urate-lowering drugs

Keywords: chronic kidney disease stage 5 hemodialysis pegloticase
efficacy of a triclosan formulation to control the initial subgingival biofilm formation

Conditions: Dental Plaque

Summary: the aim of the study is to compare the effect of a suspension containing triclosan in dynamic of the subgingival biofilm formation versus a placebo suspension. the initial subgingival biofilm formation will be evaluated by means of plaque free zone (pfz).

this is a double blind, cross over, randomized clinical trial. 28 volunteers will stop mechanical supragingiva biofilm removal measures for 96h following a complete scaling and polishing of the tooth surfaces. during this period they will be asked to rinse for one minute with a slurry of either a triclosan containing dentifice or a control without triclosan. every 24h the presence of deposits will be registered with special atention to the presence of a plaque free zone between the apical border of the deposits and the gingival margin. absence of deposits is scored 0, presence of deposits and plaque free zone =1 and presence of deposits and absence of plaque free zone =2 (maliska, a. n. et al. measuring early plaque formation clinically. oral health preventive dentistry, v. 4, p. 273-278, 2006). the prevalence of scores and the rate of changes from scores 0 and 1 into 2 will be evaluated for significance. sample size was calculated taking the results from the study o maliska, an (2006) as reference.

Eligibility criteria:
inclusion criteria: * age from 18 years; * non-smokers; * have good general health; * present at least 20 natural teeth in the mouth, including the incisors, canines and premolars without restorations, crowns, gingival recession, anatomic defects, gingivitis e/or periodontitis. exclusion criteria: * positive history of using antibiotic e/or anti-inflammatory drugs in the month previous to the initial consultation; * positive history of allergies at using triclosan; * pregnant or lactating patients; * patients in use of fixed orthodontic appliance.

Keywords: biofilm triclosan crossover clinical trial
effect of levodopa on human multifocal electroretinogram

Conditions: Retinal Diseases

Summary: it is known that dopamine is a functional neuromodulator at several levels of the visual system. dopamine seems to be involved in the organization of the ganglion cell and the bipolar cell receptive fields and modulation of physiological activity of photoreceptors. there is evidence for the functional significance of dopaminergic modulation of visual sensitivity in humans which confirms the hypothesis that dopamine plays an important role in retinal light adaptation as well as in motion and contrast sensitivity function. the electrophysiological effects of dopamine, various dopamine antagonist and levodopa in animals and humans have been investigated by means of visual evoked potentials and electroretinograms. the multifocal erg technique, developed by sutter et al. allows a rapid, simultaneous recording of focal ergs from multiple retinal locations. although this technique is relatively new, it has already provided insights into the mechanisms of retinal diseases (e.g. involvement of visual system in parkinson disease), but until now there is no data on influence of dopaminergic substances on merg.


Eligibility criteria:
inclusion criteria: * men aged between 19 and 35 years, nonsmokers * body mass index between 15th and 85th percentile * normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant * normal laboratory values unless the investigator considers an abnormality to be clinically irrelevant * normal ophthalmic findings, ametropia \< 3 dpt exclusion criteria: * regular use of medication, abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study * treatment in the previous 3 weeks with any drug * symptoms of a clinically relevant illness in the 3 weeks before the first study day * history of hypersensitivity to the trial drug or to drugs with a similar chemical structure * history or presence of gastrointestinal, liver or kidney disease, or other conditions known to interfere with, distribution, metabolism or excretion of study drugs * blood donation during the previous 3 weeks

Keywords: electroretinography levodopa
a single and low dose of recombinant factor viia in patients with severe factor xi deficiency undergoing surgery

Conditions: Hemophilia C

Summary: lately the investigators found that patients with severe factor xi deficiency and inhibitors could undergo major surgery with a single low dose of recombinant factor viia and tranexamic agent. these results encourage us to apply this treatment in clinical trial setting to patients with severe factor xi deficiency undergoing surgery instead of blood product.

eligible patients will be those with severe factor xi deficiency who agree to participate in the study . the treatment does not apply to patients requiring coronary artery bypass or other vascular surgery.

Eligibility criteria:
inclusion criteria: * patients with severe factor xi deficiency who will give informed consent to participate in the study exclusion criteria: * patients with atherosclerosis disease i.e. unstable angina pectoris or recent stroke * patients who required aorto-coronary bypass or any vascular surgery

Keywords: recombinant factor viia factor xi deficiency
video-assisted surgery or talc pleurodesis in treating patients with malignant mesothelioma

Conditions: Malignant Mesothelioma; Metastatic Cancer

Summary: rationale: video-assisted surgery to remove part of the tissue layer covering the inside of the chest cavity may be effective in treating pleural effusion and cause less damage to normal tissue. talc pleurodesis may keep fluid from building up in the chest cavity. it is not yet known which therapy is more effective in treating pleural effusion caused by malignant mesothelioma. purpose: this randomized phase iii trial is studying video-assisted surgery to see how well it works compared with talc pleurodesis in treating patients with malignant mesothelioma.

objectives: primary * compare the effectiveness of video-assisted thoracoscopic cytoreductive pleurectomy vs talc pleurodesis, in terms of 1-year survival, in patients with suspected or proven malignant mesothelioma. secondary * compare the control of pleural effusion in these patients. * compare procedure-related complications in these patients. * compare the symptoms and quality of life of these patients at 3, 6, and 12 months after treatment. * compare the length of hospital stay for these patients. * compare the exercise tolerance of these patients at 3, 6, and 12 months after treatment. * determine the cost to the health service, in terms of resources used for procedures, hospital bed usage, and cost of primary and secondary care over 12 months. outline: this is a multicenter study. patients are stratified according to risk (high vs low). patients are randomized to 1 of 2 treatment arms. * arm i (video-assisted thoracoscopic \[vat\] cytoreductive pleurectomy): patients undergo vat cytoreductive pleurectomy either at the time of biopsy or after confirmation of biopsy results. * arm ii (talc pleurodesis): patients undergo talc pleurodesis via an indwelling intercostal chest drain or via thoracoscopy either at the time of biopsy or after confirmation of biopsy results. quality of life, complications, and resource use are assessed at baseline and at 1, 3, 6, and 12 months.

Eligibility criteria:
disease characteristics: * confirmed or suspected mesothelioma * any subtype allowed * pleural effusion must be present patient characteristics: * clinically fit and suitable for video-assisted thoracoscopic cytoreductive pleurectomy * prior malignancy allowed provided it no longer requires treatment and patient has a confirmed diagnosis of mesothelioma prior concurrent therapy: * no prior attempted pleurodesis by any approach

Keywords: epithelial mesothelioma recurrent malignant mesothelioma sarcomatous mesothelioma malignant pleural effusion stage ia malignant mesothelioma stage ib malignant mesothelioma stage ii malignant mesothelioma stage iii malignant mesothelioma stage iv malignant mesothelioma