Kornimate/medical-research-clean huggingface dataset:
immune checkpoint inhibitors in advanced non-small cell lung cancer and discovery of new biomarkers

Conditions: Non-small-cell Lung Cancer; Carcinoma, Non-Small-Cell Lung; Lung Neoplasm

Summary: lung cancer patients have a poor prognosis and only around 20 % is alive after 5 years. however, for advanced non-small cell lung cancer immunotherapy has become a cornerstone of treatment. two immunotherapeutic drugs for lung cancer have been approved in the last two years. immunotherapy blocks the capability of cancer cells to inactivate the patient´s immune system, thus re-enabling eradication of cancer cells. in clinical trials, immunotherapy has shown superior survival and less toxicity compared to standard chemotherapy. whether the patients are candidates for immunotherapy or not is currently based on an unprecise biomarker that poorly predicts the patients who may benefit from immunotherapy. immunotherapy can cause severe adverse effects and is expensive. consequently, novel biomarkers are urgently needed from a patient perspective as well as a socioeconomic perspective. the objective of the project is to investigate changes in genes and other signals in tissue and blood samples from immunotherapy treated lung cancer patients. the investigators expect to identify new biomarkers that can predict with high precision, which patients may benefit from immunotherapy. on-treatment, the investigators also aim to identify biomarkers that predict the treatment response and reveal the underlying mechanisms when cancer cells become resistant to the treatment.


Eligibility criteria:
inclusion criteria: * biopsy verified nsclc * ≥ 18 years * who/ecog performance status ≤ 2 * measurable disease according to recist 1.1 * candidate for immunotherapy treatment * understand and accept oral and written information * written informed consent exclusion criteria: * candidate for surgical and/or oncological treatment with curative intention * other synchronous cancer

Keywords: immunotherapy immune checkpoint inhibitors biomarkers sequencing
comparison of joint awareness between fixed-bearing and mobile-bearing total knee arthroplasty using titanium-nitride coated posterior-stabilized prostheses

Conditions: Osteoarthritis, Knee; Arthropathy of Knee; Joint Awareness

Summary: comparison of postoperative patient's joint awareness as well as clinical and radiological outcomes between fixed- and mobile-bearing total knee arthroplasty of which the prosthesis is coated with titanium-nitride.

despite numerous comparison studies between mobile- and fixed-bearing tka as well as several comparison studies regarding clinical and radiological outcomes using titanium-nitride(tin) prosthesis, there has been no study on postoperative joint awareness despite mobile- and fixed-bearing tka using tin prosthesis.

Eligibility criteria:
inclusion criteria: * diagnosed with knee joint advanced osteoarthritis * age over 55 years old * scheduled to undergo primary total knee arthroplasty exclusion criteria: * post-traumatic or inflammatory osteoarthritis * those who undertook previous ligamentous surgery * those who do not understand and give answers to a survey
physiological reconditioning program administered remotely in patients undergoing transcatheter aortic valve replacement: a pilot study

Conditions: Frailty; Transcatheter Aortic Valve Replacement; Rehabilitation

Summary: the prepare tavr pilot study will examine the effects of remotely administered physiological reconditioning program (rapr) on quality of life (qol) and clinical outcomes at one year post tavr in frail older adults.

the main objective of this study is to evaluate the effects of a home based exercise and dietary intervention program on the quality of life (qol) and clinical outcomes in frail adults undergoing transcatheter aortic valve replacement (tavr) procedures. patients will be randomly (1:1) assigned to the standard of care (soc group) where patients will receive all medical care as decided by their treating physicians or assigned to a home based program known as remotely administered physiological reconditioning (rpr) program which will include receiving personalized instructions for a progressive exercise program and dietary changes. patients will be contacted for regular phone and in-person follow up for monitoring their progress. the primary endpoint will be quality of life as assessed by kccqe questionnaires at one-year post tavr. the secondary endpoints include length of stay post tavr, all-cause mortality, repeat hospitalization and a composite of all-cause mortality and repeat hospitalization at one year.

Eligibility criteria:
inclusion criteria: - short physical performance battery protocol (sppb) score \< 9 exclusion criteria: * severe liver disease defined by childs pugh class \>b or meld score \>15. * severe kidney disease defined by egfr \<30 ml/min. * hospital admission during the 4 weeks prior to randomization. * montreal objective cognitive assessment (moca) score \<18. * mechanical fall in the past month. * unstable angina during the previous month. * myocardial infarction during the previous month. * unsuccessful completion of the one-week run-in phase. * syncopal episode during exercise during run-in phase
markers of osteoporosis in cystic fibrosis

Conditions: Cystic Fibrosis

Summary: main study up to 100 subjects, both non-cf volunteers and cystic fibrosis (cf) patients, will participate in a single study visit that will include a dexa scan, micro ct, and blood collection. denosumab (prolia) sub study approximately 10 adult subjects with cf who participated in the main study and have results indicating bone disease will receive treatment with denosumab for up to 5 years. they will be asked to return annually for repeat dexa scans, micro ct, and blood collection.


Eligibility criteria:
cystic fibrosis main study inclusion criteria: * must have cf diagnosis confirmed by sweat test or genotype analysis * subjects (and parents/legal guardians as applicable) must have the ability to read and write in english sub-study exclusion criteria: * no cf diagnosis * men or women without osteoporosis * less than 18 years of age * unwilling to return annually for study visits for up to 5 years * unwilling and/or medically unable to take denosumab
does the negativation of the glucose hydrogen breath test come along with a reduction of the symptoms of gaz incontinence ?

Conditions: Anal Incontinence

Summary: the objectives of this work are: 1/to estimate the frequency of a positive glucose breath test in favour of a small intestinal bacterial overgrowth in a population of patients consulting for gaz incontinence by comparison to a population of control subjects; 2/to estimate versus a conventional treatment the efficiency of an antibiotic treatment; in case of small intestinal bacterial overgrowth diagnosed by the glucose breath test, to improve gaz incontinence


Eligibility criteria:
inclusion criteria: * gaz incontinence for more than 3 months * afflilied to national health security * having read and sign the information letter and consent form exclusion criteria: * pregnancy * use of antibiotics, probiotics, ipp for less tha n 3 months * past of small intestinal bacterial overgrowth * ischemic, inflammatory colitis,colo-rectal cancer * diabetes * allergy to metronidazole * psychiatric disease * patients who do not speak or read french
phase 1/2 study of mocetinostat and durvalumab in patients with advanced solid tumors and nsclc

Conditions: Advanced Cancer

Summary: mocetinostat (mgcd0103) is an orally administered hdac inhibitor. durvalumab (medi4736) is a human monoclonal antibody that is an inhibitor of the programmed cell death ligand (or pd-l1). durvalumab is also known as a checkpoint inhibitor. this study is evaluating the combination regimen of mocetinostat and durvalumab in participants with advanced or metastatic solid tumors and non-small cell lung cancer.


Eligibility criteria:
inclusion criteria: * phase 1-diagnosis of advanced or metastatic solid tumor; phase 2-diagnosis of nsclc * not amenable to treatment with curative intent * adequate bone marrow and organ function exclusion criteria: * impaired heart function * uncontrolled tumor in the brain * other active cancer

Keywords: mgcd0103 medi4736 mocetinostat durvalumab hdac inhibitor pd-l1 inhibitor phase 1 phase 2 metastatic solid tumor non-small cell lung cancer immunotherapy checkpoint inhibitor
immune dysfunction in critical illness: utility of a panel of genes and molecules involved in the immunological synapse

Conditions: Critical Illness

Summary: critical illnesses represent a significant physiological assault that triggers changes in the patient's immune system, resulting in an immunopotentiating response (systemic inflammatory response syndrome, sirs) and an immunosuppressive response (compensatory anti-inflammatory response syndrome, cars). the balance between sirs and cars is essential for the patient to return to a state of immune homeostasis and accelerate the healing process. however, when cars is disproportionately intense, it leads to a state of immunoparalysis, which predisposes the patient to vulnerability to opportunistic infections, associated with a peak in late mortality. the majority of patients admitted to the icu are considered immunocompetent. however, the investigators suspect that a significant proportion of them exhibit predominance of cars and a state of functional immunosuppression. there is currently no diagnostic test to determine whether a patient is functionally immunocompetent at a specific point in time. the goal of this observational study is to learn about the immune system dysfunction occurring in critical illness. the main questions it aims to answer are: * what is the prevalence of immune system dysfunction in critical illness? * does immune system dysfunction affect multiple organ failure trajectory and mortality in critical illness? * is immune system dysfunction related to an increased risk of opportunistic hospital-acquired infections in critical illness? * is immune system dysfunction related to age, fragility, nutritional status or previous comorbidities in critical illness? to answer these questions, the investigators will prospectively study a population of critically ill patients, defined by the presence of organ failure. the investigators will analyse a panel of genes and molecules involved in immunological synapse, using peripheral blood samples at different moments of the evolution of critical illness. based on the analysis, the investigators will classify the patients' functional immune status and correlate it with the outcomes.


Eligibility criteria:
inclusion criteria: * failure of one or more organs, assessed by a sequential organ failure assessment score (sofa) ≥4 within the first 24 hours of admission to the intensive care unit (icu). at least one of the physiological systems involved must be in the category of organ failure and, therefore, score ≥3. * informed consent to participate in the study. * age equal to or greater than 18 years. exclusion criteria: * pharmacological immunosuppression within the 3 months prior to the current admission date, including treatment with corticosteroids, immunosuppressive drugs (conventional or biological), or chemotherapy. * immunodeficiency. * age under 18 years. * absence of consent to participate in the study.

Keywords: critical illness
a triple combination therapy study of boceprevir, pegasys and copegus in previously untreated patients with genotype 1 chronic hepatitis c

Conditions: Hepatitis C, Chronic

Summary: this open-label, multicenter, treatment response guided study will evaluate the sustained virological response and safety of the triple combination therapy boceprevir, pegasys (peginterferon alfa-2a) and copegus (ribavirin) in previously untreated patients with genotype 1 chronic hepatitis c. in the lead-in phase, patients will receive a dual combination therapy of pegasys and copegus for 4 weeks. in the following triple combination therapy phase, 800 mg boceprevir, 180 mcg pegasys and 1000-1200 mg copegus will be administered for 24, 32 or 44 weeks; the duration depending on the patient's treatment response. the anticipated time on study treatment is up to 48 weeks.


Eligibility criteria:
inclusion criteria: * adult patients \>/=18 years of age * chronic liver disease consistent with chronic hepatitis c, genotype 1 infection * serum hcv rna quantifiable at screening * patients who have not been previously treated with pegylated interferon (ifn), standard ifn, rbv or any direct acting anti-viral agent * compensated liver disease (child-pugh grade a clinical classification for patients with cirrhosis: total score \</=6) * negative urine or blood pregnancy test (for women of childbearing potential) exclusion criteria: * women with ongoing pregnancy or breast feeding * male partners of women who are pregnant * therapy with any systemic anti-viral, anti-neoplastic or immunomodulatory treatment \</=6 months prior to the first dose of study drug * any investigational drug \</=6 weeks prior to the first dose of study drug * history or other evidence of decompensated liver disease * history or other evidence of a medical condition associated with chronic liver disease other than chronic hepatitis c * signs or symptoms of hepatocellular carcinoma * co-infection with hcv genotypes other than genotype 1 * co-infection with hepatitis a, hepatitis b, and/or human immunodeficiency virus (hiv) * any patient with an increased risk for anemia * history of severe psychiatric disease * history of immunologically mediated, chronic pulmonary, or severe cardiac disease * current diseases that are not adequately controlled
dendritic cell based therapy of renal cell carcinoma

Conditions: Advanced Renal Cell Carcinoma

Summary: the purpose of this study is to show if vaccination with autologous dendritic cells pulsed with peptides or tumor lysate in combination with adjuvant cytokines can induce a measurable immune response in patients with metastatic renal cell carcinoma, and to evaluate the clinical effect (objective response rate) of the vaccination regime.

eligible patients receive vaccination with tumor antigen pulsed autologous monocyte-derived mature dendritic cells with a fixed interval. the dendritic cells are generated from leukapheresis products and frozen after antigen loading. hla a2 positive patients are treated with padre and oncopeptide pulsed dc; survivin and telomerase peptides. hla a2 negative patients are treated with klh and tumorlysate pulsed dc; autologous or allogeneic. each patient is given 6 immunizations with at least 5x106 peptide/lysate pulsed autologous dc. vaccination 1-4 is given weekly and 4-6 at 2-week intervals. those patients who exhibit stable disease, partial response or complete response after 6 injections will be given 4 more vaccinations at 2-week interval. the vaccine is applied by intradermal injection near the inguinal region. il-2 2 miu s.c. day 2-6 and thymosin alpha 1 (zadaxin®, sciclone) 1,6 mg s.c. twice a week are used for adjuvants. scans and re-staging tests are performed at scheduled intervals throughout the study.

Eligibility criteria:
inclusion criteria: * histologically proven progressive metastatic or locally advanced renal cell carcinoma * no standard treatment indicated * age: \> 18 * who-performance status 0-1 * at least tone measurable tumor lesions according to the recist criteria. * life expectancy more than 3 months * acceptable cbc and blood chemistry results * written informed consent exclusion criteria: * patients with a history of any other neoplastic disease less than 5 years ago (excepting treated carcinomas in situ of the cervix and basal/squamous cell carcinomas of the skin). * patients with metastatic disease in the central nervous system (cns). * patients with other significant illness including severe allergy, asthma, angina pectoris or congestive heart failure. * patients with acute or chronic infection including hiv, hepatitis and tuberculosis. * patients who are pregnant. * patients who have received antineoplastic therapy including chemotherapy or immunotherapy less than 4 weeks before beginning the trial. * patients who receive corticosteroids or other immunosuppressive agents. * baseline serum ldh greater than 4 times the upper limit of normal. * patients with active autoimmune diseases such as lupus erythematosus, rheumatoid arthritis or thyroiditis.

Keywords: dendritic cell vaccine renal cell carcinoma
pcsk9 inhibitors in the progression of aortic stenosis

Conditions: Aortic Valve Stenosis

Summary: investigators plan evaluate whether pcsk9 inhibitors, a medication that can lower lipoprotein(a) and control dyslipidemia, can inhibit the progression of aortic stenosis, through a randomized controlled trial.

aortic valve disease is the most common form of heart valve disease and is a major burden to society. aortic valve disease is also expected to become more prevalent with the aging. among aortic diseases, 'aortic stenosis (as)', which is a narrowing of the aortic valve, and leads to symptoms of heart failure and sometimes death. for treatment of as, the valve in replaced in a surgical to percutaneous method. regardless of the method, valve replacement has its potential costs and complications that is an important issue that needs to be solved. therefore, controlling the progression of as and increasing the efficacy of medical therapy before valvular replacement is needed, is an important medico-social problem. regarding the pathophysiology of as, an elevation of lipoprotein(a) and dyslipidemia have been reported to be associated with the progression of cardiovascular calcification. pcsk9 inhibitors, which is a medication that can control both lipoprotein(a) and dyslipidemia may be a effective medication to control the progression of as. therefore, investigators will perform a randomized control trial, to compare the effect of pcsk9 inhibitors vs. placebo in its influence to as progression.

Eligibility criteria:
inclusion criteria: 1. the patient agrees to participate in this study by signing the informed consent form. alternatively, a legally authorized patient representative may agree to the patient's participation in this study and sign the informed consent form. 2. the patient has a working diagnosis of aortic stenosis (mild to moderate), and has fair treatment compliance. exclusion criteria: 1. age under 19 years old 2. hypersensitivity to pcsk9 inhibitor 3. ldl cholesterol \< 70mg/dl at baseline 4. poor treatement compliance (the patient will need to visit the out-patient clinic every 2-weeks for medication) 5. positive pregnancy test or is known to be pregnant 6. any other reason the investigator deems the subject to be unsuitable for the study (e.g., active malignant tumor, any life-threatening condition with life expectancy less than 6months, etc.) 7. any clinically significant abnormality identified at the screening visit, physical examination, laboratory tests, or electrocardiogram which, in the judgment of the investigator, would preclude safe completion of the study

Keywords: aortic valve stenosis pcsk9 inhibitor
effectiveness of parent-led interventions in reducing infant hypersensitivity to pain

Conditions: Pain

Summary: the aim of this study is to find out the effects of routinely using different types of pain-relieving strategies during routine immunization injections performed in infants.


Eligibility criteria:
inclusion criteria: 1. healthy infants undergoing vaccination. exclusion criteria: 1. preterm birth (\<37 weeks gestation) 2. prior hospitalization/surgery (other than postnatal care), 3. documented/ suspected sensitivity/allergy to amide anaesthetics/vaccines, 4. mother plans to breastfeed or to use topical anesthetics or sugar water during injection.

Keywords: pediatrics pain immunization
caries inhibitory effect of nano silver and tri calcium phosphate varnishes among visually impaired children

Conditions: Dental Caries

Summary: assessment of ph,streptococcus mutants count, lactobacillus count and immunoglobulin a among visually impaired children after nano silver varnish application it tri calcium phosphate phosphate varnish application

sixty children will be randomly divided into three equal treatment groups, composed of 20 children each, according to the type of material used as follows: * group i: children will receive oral health education and nano silver fluoride varnish. * group ii: children will receive oral health education and tri calcium phosphate varnish. * group iii: children will receive oral health education for all children ,assessment of ph, streptococcus mutants count, lactobacillus count and immunoglobulin a will be assessed at baseline, one day , 3 months and 6 months after application

Eligibility criteria:
inclusion criteria: visually impaired children exclusion criteria: * uncooperative children or children not willing to participate in the study. * children with systemic diseases * children with bronchial asthma. * children who were on antibiotic or medications that might affect oral flora or salivary flow taken within the previous 3 months * history of fluoride treatment in the past 3-4 weeks.
a research study to assess the safety, pharmacokinetics and pharmacodynamics of dur-928 in patients with alcoholic hepatitis

Conditions: Alcoholic Hepatitis

Summary: this is a research trial testing dur-928 (an experimental medication). the purpose of this trial is to assess the dose related safety, pharmacokinetics, and pharmacodynamics of dur 928 in patients with moderate and severe alcoholic hepatitis (ah).


Eligibility criteria:
inclusion criteria: 1. able to provide written informed consent (either from patient or patient's legally acceptable representative) 2. male or female patients 21 years of age or older with bmi ≥ 20 to ≤ 40 kg/m2 3. patients with alcoholic hepatitis defined as: 1. history of heavy alcohol abuse: \> 40 g/day in females or \> 60 g/day in males for a minimum period of 6 months, and 2. consumed alcohol within 12 weeks of entry into the study, and 3. serum bilirubin \> 3 mg/dl and ast \> alt, but less than 300 u/l and 4. meld score between 11-30, inclusive 4. no evidence of active infection as determined by the investigator. 5. women of child-bearing potential must utilize appropriate birth control throughout the study duration. 6. male patients must agree to use a medically acceptable method of contraception/birth control throughout the study duration exclusion criteria: 1. other or concomitant cause(s) of liver disease as a result of: 1. autoimmune liver disease 2. wilson disease 3. vascular liver disease 4. drug induced liver disease 2. co-infection with human immunodeficiency virus (hiv) or hepatitis b 3. any active malignancies other than curatively treated skin cancer (basal cell or squamous cell carcinomas) 4. if female, known pregnancy, or has a positive serum pregnancy test, or lactating/breastfeeding 5. serum creatinine \> 2.5 mg/dl 6. patients who have had organ transplantation (such as liver, kidney, lung, heart, bone marrow, or stem cell etc.), other than cornea transplant 7. stage 3 or greater encephalopathy by west haven criteria

Keywords: alcoholic hepatitis acute alcoholic liver disease progressive inflammatory liver injury iv infusion