Kornimate/medical-research-clean huggingface dataset:
survival endpoints for treatment evaluation in subjects treated for metastatic breast cancer: contribution of real-life databases

Conditions: Cancer

Summary: overall survival (os) is considered the most reliable cancer endpoint and used by the health rregulatory authorities (hra). os presents multiple advantages in cancer randomized controlled trials (rct): it is universally accepted as a measure of clinical benefit for the patient; it is objectively defined, both in terms of events and date of incidence; it is easily and precisely measured and thus reproducible; it can be exhaustively collected. as such, os has been validated by hras. on the other hand, os presents some limitations. observing a benefit on os may require a large number of patients and/or considerable time for patient follow-up. costs for trials may be increased, and there might be delays in the introduction of possible beneficial treatments for patients. the development of alternative endpoints that could capture treatment benefit appropriately and be measurable earlier, is central for the evolution of clinical research in oncology. real world data (rwd) are defined as other sources than clinical trials such as: electronic medical records, registries, insurance claims, pharmacy records, death certificates and other patient-generated data. this research is aimed at (i) describing the existing endpoints of survival in real-life setting, (ii) comparing the correlation at individual level with data to clinical trials for related to anti-her2 targeted therapies and endocrine therapies in mbc. we will investigate the individual correlation between candidate surrogate endpoints and overall survival in a population-based record-computerized database centralizing data on about 20,000 patients from 2008 to 2017 in france. this work should lead to the estimation of various time-to event endpoints (e.g. os, pfs, etc), in the real-life setting, for mbc patients. in addition, we will estimate their individual correlation with os, which should help us highlight potential surrogate endpoints in this setting. we will focuss on three distinct population, accounting for a large population of mbs patients: : patients treated with anti-her2 targeted agents, patients treated with endocrine therapies and elderly population.


Eligibility criteria:
inclusion criteria: * metastatic breast cancer exclusion criteria: * individual patient data unavailable

Keywords: metastatic breast cancer real world data surrogate
the immunogenicity and persistence of booster dose with hepatitis b vaccine in college students

Conditions: Hepatitis B Vaccine

Summary: the anti-hbs produced after hepatitis b vaccination will decrease over time. college students are vaccinated with hepatitis b vaccine at birth, and their antibodies may have decreased significantly. in addition, college students are sexually active population, which has a high risk of hbv infection. it is necessary to study the anti-hbs level of college students, and analyze the strengthening immunization for this special group. this study will analyze the immunogenicity, immune persistence, and safety of booster dose of intramuscular 20 µg recombinant hepatitis b vaccines. different booster vaccination including one-dose (0 month), two-dose (0, 1 months), or three-dose (0, 1, and 6 months) was given according to the antibody production level after booster vaccination among college students.

participants are given booster dose of one-dose (0 month), two-dose (0, 1 months), or three-dose (0, 1, and 6 months) 20 µg recombinant hepatitis b vaccine according to the antibody production level. hbsag and anti-hbs will be tested during the study period. adverse reactions will be recorded after vaccination.

Eligibility criteria:
inclusion criteria: * aged of 18 years or above * serologically negative for hepatitis b surface antigen (hbsag), hepatitis b surface antibody (anti-hbs) at enrollment * sign informed consent, willing to participate in this study exclusion criteria: * being pregnant * intolerance or allergy to any component of the vaccine * participants with severe acute or chronic diseases (such as liver disease, blood disease, cancer), acute onset of chronic diseases and fever

Keywords: hepatitis b vaccine immunogenicity booster dose long-term immune response college students
ureteral stent length and patient symptoms

Conditions: Kidney Stones

Summary: the study of whether or not ureteral stent length affects patient comfort after electro-shock wave treatment for kidney stones.

patients undergoing electro shock wave for treatment of kidney stones are randomized to long or short stent length after signing an informed consent prior to their surgery. they keep a pain diary and medication diary for a two week period after the stent is placed. these are turned in at the two week post-op visit. patients also complete a quality of life and urinary symptom score questionnaire pre and post operatively.

Eligibility criteria:
inclusion criteria: male or female over 18 years of age, will be receiving electro-shock wave therapy for kidney stones - exclusion criteria:under 18 years of age, inability to give informed consent -
intraocular lens (iol) calculation improvement

Conditions: Cataract

Summary: intraocular lens (iol) formulas sometimes differ from expected. using novel measurement methods before and after cataract surgery improved formulas are tried be developed.


Eligibility criteria:
inclusion criteria: * older 18 * clear cornea * cataract

Keywords: cataract refraction iol calculation formula
evaluation of the erector spinae muscle in different position and the change after receiving myofascial release.

Conditions: Low Back Pain

Summary: the purpose of this experiment is to evaluate whether myotonpro can quantify the changes in the muscle characteristics of the erector spinae in different postures and after myofascial relaxation, and to test the validity of the muscle tone tester.

in clinical practice, manual muscle testing (mmt) and modified ashworth scale (mas) grading systems are often used to assess muscle tension and tension. although these methods are considered feasible, because these methods are mainly classified based on the subjective perception of the evaluator, the reliability and accuracy of the evaluation results are often questioned. therefore, we should seek a way to objectively evaluate muscle tension with biomechanical properties and quantitative data to solve these deviations. myotonpro (myoton as, tallinn, estonia) is a tester that uses biomechanical principles to collect muscle tension status. this handheld muscle tension tester uses mechanical pressure and reaction force feedback to calculate through biomechanical conversion. the tone, stiffness and elasticity of the muscle are expressed as quantitative data. there have been many use reports showing that the muscle tone meter has the feasibility of quantifying muscle tone. the erector spinae is one of the most important back muscles of the human body. after contraction, the entire spine can be erected, allowing the upper body to stand upright. when the posture changes, such as: sitting posture, hunchback, bending over, erector spinae will be stretched or continuously contracted due to different postures, resulting in changes in muscle characteristics. therefore, if the erector spinae is used improperly for long-term poor posture, the erector spinae is easily damaged due to heavy burden, which can easily cause back pain. myofascial release (myofascial release) is a soft tissue massage method that loosens the fascia with hands. by changing the mechanical properties of the muscles, it can loosen over-tension or tense muscles. it is the most commonly used by physical therapists to loosen muscles. one of the operation techniques. however, there is no literature to quantify the effect of myofascial mobilization. the purpose of this experiment is to evaluate whether myotonpro can quantify the changes in the muscle characteristics of the erector spinae in different postures and after myofascial relaxation, and to test the validity of the muscle tone tester.

Eligibility criteria:
inclusion criteria: age 20-65 healthy adult exclusion criteria: 1. radicular neurological signs 2. spinal deformity e.g.scoliosis, spondylolisthesis 3. infection or tumor 4. rheumatologic conditions 5. previous spinal surgery 6. history of hip or pelvic disorder that required treatment 7. male bmi\> 27 and female bmi\> 26

Keywords: muscle tension tester muscle characteristics erector spinae muscles different postures myofascial release
comparison of 1.5t vs. 3t protocols after treatment with glatiramer acetate (ga)

Conditions: Multiple Sclerosis

Summary: this study will: * explore whether ga decreases inflammation more on the 3t optimized protocol when compared to the 1.5t standard protocol. * compare whether the decrease in the cumulative number of gd-enhancing lesions significantly differs between pre-treatment (day 0) and post-treatment (12 months) using 1.5t standard and 3t optimized protocols. * investigate the correlation between mtr and the cumulative number and volume of gd enhancing lesions on 1.5t standard and 3t optimized protocols in patients treated with ga. this study suggests that ga may favorably affect early events in lesion formation, in addition to exerting more transient beneficial effects on established areas of inflammation and demyelination, and that this effect may be observed only with the 3t optimized protocol.

interferon-β (ifn- β) and glatiramer acetate (ga) are the two main groups of drugs used in the treatment of multiple sclerosis (ms). notably, while both ultimately decrease central nervous system (cns) inflammation, they do so by very different mechanisms. therefore, use of 1.5t mri, triple dose of gd, delay of scanning time for 20-30 min after gd injection, and application of off-resonance saturated mt pulse may increase the ability to detect gd lesions by approximately 120% when compared to 1.5t single dose mri protocol. the 3t standard protocol may increase the ability to detect gd enhancing lesions by 40-50% when compared to the 1.5t standard protocol. this may indicate that the 3t optimized protocol may increase the ability for gd lesion detection by approximately 150-180%, when compared to the 1.5t standard protocol.

Eligibility criteria:
inclusion criteria: * patients diagnosed with clinically definite ms according to the mcdonald criteria * have a gd enhancing lesion using 1.5t standard protocol and/or an acute relapse * age 18-65 * have a relapsing-remitting (rr) disease course or clinically isolated syndrome (cis) with high risk of conversion to clinically definite (cd) ms (presence of \>9 t2 lesions in addition to 1 gd lesion) * have edss scores less than or equal to 5.5 * have disease duration of 3 months to 30 years * none of the exclusion criteria exclusion criteria: * previous immunomodulatory or immunosuppressant treatment during the 30 days prior to day 0 of the study with the following agents (e.g., ifn-β, ga, mitoxantrone, cyclophosphamide, cladribine, fludarabine, cyclosporine, total body, azathioprine, methotrexate, ivig, cellcept, natalizumab, etc.)

Keywords: inflammation multiple sclerosis glatiramer acetate gd enhancing lesions 1.5t protocol 3t protocol magnetization transfer imaging (mti) lesion activity analysis copaxone
clinical trial for non-inferiority and safety of tenofovir alafenamide and tenofovir disoproxil fumarate in patients with hematologic malignancies who require prophylactic hepatitis b antiviral treatment

Conditions: Patients With Malignant Blood Disease Requiring Hepatitis B Antiviral Medication

Summary: his clinical trial was conducted to determine the non-inferiority and safety of prophylactic antiviral treatment of tenofovir alafenamide (taf) compared to tenofovir disoproxil fumarate (tdf) in patients with malignant hematological diseases requiring prophylactic hepatitis b antiviral treatment. confirm. in the case of taf, domestic evidence when used as a first-line treatment is insufficient, so in this clinical trial, the virus suppression effect compared to tdf during the first administration of taf to patients with malignant hematological diseases requiring prophylactic hepatitis b antiviral treatment was investigated. we aim to secure non-inferiority and additionally confirm the safety of taf's known advantages of reducing renal function damage and protecting bone function.


Eligibility criteria:
inclusion criteria: 1. adult men and women over 19 years of age and under 65 years of age 2. patients who meet the following criteria a or b a. those scheduled for hematopoietic stem cell transplantation and treatment with immunosuppressants or chemotherapy. b. those scheduled to receive anticancer treatment including rituximab 3. hbcab positive patient 4. patients who voluntarily agreed to participate in this clinical trial and signed a written consent form exclusion criteria: 1. patients taking oral chronic hepatitis b antiviral drugs before starting the study 2. galactose intolerance. patients with genetic problems such as lapp lactase deficiency or glucose-galactose malabsorption 3. patients with hypersensitivity to tenofovir alafenamide citrate or tenofovir disoproxil orotate 4. patients with abnormal renal function (e-gfr less than 15ml/min) or end-stage renal disease requiring dialysis 5. hepatitis c patients 6. hiv-infected patients 7. pregnant women, lactating women, or patients planning to become pregnant 8. if you are participating in another clinical trial administering medication 9. patients who do not agree to participate in this clinical trial 10. adults with impaired consent capacity who are unable to give consent on their own 11. those who have taken other clinical trial drugs for less than 24 weeks 12. other clinically determined by the principal investigator to be difficult for the clinical trial subject to conduct the clinical trial.
safety and efficacy of sofosbuvir-based regimens in clinical practice for the treatment of chronic hepatitis c virus infection in india

Conditions: Hepatitis C Virus

Summary: this study will evaluate the safety and efficacy of sofosbuvir (sof)-based regimens administered as per the approved prescribing information in adults with chronic hepatitis c virus (hcv) infection treated in routine clinical practice in india.


Eligibility criteria:
inclusion criteria: * hcv-infected patients living in india * treatment with a sof-based regimen as determined by the patient's treating physician per the approved prescribing information. * patients who provide written and signed informed consent prior to initiation of treatment where required. exclusion criteria: * concurrent participation in an hcv clinical trial (except trials not testing investigational medicinal products) * patients presenting a risk of not being able to be followed (eg, patients planning to move or leave the country in a foreseeable future)
prediction of acute rejection in renal transplant

Conditions: Kidney Transplant

Summary: acute rejection is still a major risk factor affecting the prognosis of kidney transplant patients. alloreactive cells of the recipient infiltrate the kidney graft and cause inflammatory reaction which damages the graft structure and function. conventional diagnosis of acute rejection is based on clinical symptoms and kidney biopsy examination. the clinical symptoms are a result of the kidney damage, which occurs days after the initiation of the rejection reaction. kidney biopsy is an invasive and expensive procedure. it has been wished to have new parameters that can replace/supplement the conventional procedures. chemokines are small molecules that attract inflammatory cells. changes of chemokine levels in the urine may correlate with the immune status in the kidney. a systematic study to evaluate the chemokine levels in urine and correlation with the kidney biopsy pathology will answer the question whether monitoring of urinary chemokines would be useful in predicting graft rejection/damage.


Eligibility criteria:
inclusion criteria: * one hundred subjects undergoing kidney biopsy for suspected rejection * forty subjects that have stable graft function with normal level of blood creatinine (no biopsy is needed at the time of sample collection). exclusion criteria: * subjects under the age of 18 * gender of potential subjects male or female * age limits greater than 18 years of age
prospect: predictors of response to cardiac re-synchronization therapy

Conditions: Heart Failure; Congestive Heart Failure; Cardiomyopathy

Summary: heart failure is a progressive disease that decreases the pumping action of the heart. this may cause a backup of fluid in the heart and may result in heart beat changes. using a medical device like a pacemaker or a defibrillator can help the heart to pump in regular beats. however, not all patients do better with a device. currently, there is not a way to identify which patients will benefit from the device. the purpose of this study is to determine if using medical tests, echocardiogram, can help in predicting which patients will improve. the types of patients needed for this study are those who have been diagnosed with moderate or severe heart failure.


Eligibility criteria:
inclusion criteria: * moderate to severe heart failure * ejection fraction ( measurement of blood pumped out of the heart) less than 35% * wide (greater than 130 milliseconds) qrs duration for us patients only. * may include patients with less than 130 millisecond qrs duration if they have mechanical dyssynochrony (uncoordinated heart contractions) in europe. * all patients enrolled should be stable on medications that include at least an ace inhibitor or angiotensin receptor blocker (arb) and at optimal level for at least one month prior to surgery exclusion criteria: * patients that are not eligible for this study are those that have a mechanical right heart valve or are experiencing the following medical conditions within the last 3 months: * chest pain / unstable angina * acute heart attack * chronic or permanent atrial arrhythmias such as atrial fibrillation * contrary artery bypass graft (cabg) * percutaneous transluminal coronary angioplasty (ptca) * patients who have had intermittent or continuous inotropic drug therapy are not eligible for this study. * patients who have had heart transplant or a prior cardiac resynchronization therapy device are not eligible for this study. * patients who are pregnant or are of child-bearing potential are not on a form of birth control may not participate in this study.

Keywords: heart failure congestive heart failure fluid overload left sided heart failure pacemaker defibrillator
a mobile and web-based clinical decision support and monitoring system for diabetes mellitus patients in primary care

Conditions: Diabetes Mellitus

Summary: the purpose of the study is to develop a user-friendly, comprehensive, fully integrated web and mobile-based clinical decision support and monitoring system (cdsms) for dm diseases screening, diagnosis, treatment and monitoring for the use of physicians and patients in primary care and to determine the effectiveness of the system. for validating the cdsms for diabetes patients, randomized controlled trial will be conducted.a parallel single blind randomized controlled trial will be implemented. 10 physicians and their 439 patients are involved in the study. according to the results of screening which is done using developed cdsms, dm diagnosed patients will be recruited for trial from the primary care centers by the physicians. the recruited patients will register to the cdsms with their accounts given by their physicians. eligible participants will be assigned to intervention and control groups with simple randomization. the significance level will be accepted as p\<0,05. in the intervention group, the system recommendations on diagnosis, treatment and monitoring will be carried out as the final decision given by the physician. in the control group, physicians will treat dm patients as the general routine. patients in both groups will be monitored for 6 months. patient data on 0th and 6th month will be compared. clinical and laboratory outcomes will be face-to-face assessed, others will be online self-assessed.


Eligibility criteria:
inclusion criteria: * being over age 40 * volunteer * computer and internet literacy * dm diagnosed or having at least one of diagnostic criteria. these criteria; * hba1c ≥ 6.5 * fpg ≥ 126 mg / dl * 2-hour postprandial glucose ≥ 200 mg / dl * any time postprandial glucose ≥ 200 mg / dl * diabetes symptoms exclusion criteria: * having a communication problem * type 1 diabetes * mody type dm * level of psychiatric disorders in psychosis * dementia ones
chidamide plus r-chop in newly diagnosed double-expressor diffuse large b-cell lymphoma with other molecular subtypes

Conditions: Chidamide; R-CHOP Chemotherapy; DLBCL - Diffuse Large B Cell Lymphoma; Double-expressor Lymphoma (DEL)

Summary: evaluation of the safety and efficacy of cr-chop treatment in newly diagnosed double-expressor dlbcl with other molecular subtypes

patients with the other molecular subtype of double-expressor diffuse large b-cell lymphoma (del-dlbcl) demonstrate significantly poorer survival outcomes. the deb trial demonstrated that chidamide combined with r-chop significantly improves the complete response (cr) rate in del patients and shows a definitive trend toward benefit in event-free survival (efs). therefore, we plan to evaluate the efficacy and safety of c-r-chop (chidamide plus r-chop) in treating dlbcl patients with the del other molecular subtype.

Eligibility criteria:
inclusion criteria: * patients must meet all of the following inclusion criteria to be eligible for enrollment: 1. ≥18 years of age; 2. diffuse large b-cell lymphoma diagnosed by pathological diagnosis according to who 2016 classification criteria; 3. molecular subtyping, determined through high-throughput sequencing of pathological tissue or peripheral blood, is categorized as the "other" subtype; 4. immunohistochemistry revealed overexpression of myc and bcl2: myc ≥ 40%, bcl2 ≥ 50%; 5. measurable lesions identified on cross-sectional imaging through diagnostic modalities (computed tomography \[ct\] or magnetic resonance imaging \[mri\]) are defined as the presence of at least one two-dimensional lesion with a maximum cross-sectional diameter (gtd) ≥1.5 cm, irrespective of the short-axis diameter; 6. the eastern cooperative oncology group (ecog) performance status score is ≤2； 7. adequate hepatic function is defined as: total bilirubin (tbil) ≤ 3 times the upper limit of normal (uln); alanine aminotransferase (alt) and aspartate aminotransferase (ast) ≤5 × uln; alkaline phosphatase (alp) ≤ 5 × uln; serum creatinine ≤ 1.5 × uln or creatinine clearance ≥ 35 ml/min as calculated by the cockcroft-gault formula; 8. voluntary participation with willingness to provide the aforementioned treatment data, accompanied by a signed and dated informed consent form. exclusion criteria: * patients who meet any of the following criteria will be excluded from the study： 1. currently enrolled in another clinical trial； 2. received prior lymphoma treatment with alternative regimens before enrollment; 3. presence of concurrent malignant tumors; 4. deemed ineligible for participation by the investigator's judgment； 5. presence of severe psychiatric or neurological disorders that may impair the ability to provide informed consent and/or affect the reporting or observation of adverse events； 6. patients unable to comply with follow-up requirements； 7. pregnant or lactating women, and patients of childbearing potential unwilling to use contraception; 8. active infection or uncontrolled hbv (hbsag positive and/or hbcab positive and hbv dna positive), hcv positive