Kornimate/medical-research-clean huggingface dataset:
an open-label, multi-center, phase iia trial of prx302 treatment of patients with locally recurrent prostate cancer after primary radiation therapy

Conditions: Locally Recurrent Prostate Cancer

Summary: the purpose of this study is to determine the therapeutic activity of different concentrations of prx302 at increasing volumes and/or number of deposits per gram of prostate. therapeutic activity will be determined based on changes in psa levels, psa velocity, psa doubling time and tumor burden following treatment.


Eligibility criteria:
inclusion criteria: * completed a full course of radiation therapy for prostate cancer at least 2 years before enrollment. * biochemical failure at screening as determined by either the astro or the phoenix definitions. * at least 5 available psa readings after completion of radiation therapy and prior to screening. * psa level of not greater than 10 ng/ml. * psa doubling time of at least 9 months at screening. * biopsy-proven recurrent localized prostate cancer. * tumor stage t1c to t2c. * prostate volume estimated at 40 ml or less as determined by trus. * ecog performance score 0 to 2. * serum testosterone of at least 1 ng/dl. exclusion criteria: * prior history of metastatic prostate cancer. * salvage external beam therapy and/or salvage brachytherapy prior to enrollment. * biological, immunological, chemotherapeutic treatment or cryotherapy after completing radiation. * androgen ablation therapy within 12 months prior to enrollment. * recurrence of prostate cancer within 18 months of definitive primary radiotherapy. * other medication for prostate cancer. * presence of active malignancy other than prostate cancer. * treatment with other investigational therapies within 12 months prior to enrolment. * presence of a chronic indwelling foley catheter for obstructive uropathy. * previous transurethral resection of the prostate (turp), transurethral resection of the bladder neck, photo-selective vaporization of the prostate (pvp) or other resection surgery in the urinary tract. * previous treatment with prx302. * any evidence of metastatic disease on bone scan, ct or magnetic resonance imaging (mri) within 3 months prior to enrollment.

Keywords: prostate cancer locally recurrent prx302
early response evaluation in nsclc patients treated with immunotherapy

Conditions: NSCLC, Stage IV

Summary: a pilot study with biomarker exploration.50 patients with stage iv non-small cell lung cancer (nsclc) that are eligible for treatment with nivolumab. patients will undergo a 18f-fdg-pet/ct and ebus-fna of the lymph nodes and have blood drawn before and after immune checkpoint inhibitor treatment to compare tumor fdg uptake and to identify changes in the immune effector cell subsets in tdlns. blood will be drawn in parallel to compare the distribution of immune effector cell subsets before and after treatment initiation. because of the possible burden for patients, the ebus-fna is not mandatory to complete the study and is there for an exploratory objective. also blood will be drawn for a tumor mutational burden at baseline. the first six patients will undergo a dynamic pet-ct scan in addition to a static scan to study the influence of possible immunotherapy induced changes to the body distribution and kinetics of fdg..

early response evaluation with 18f-fdg pet/ct and immunological profiling of circulating immune cells and tumor-draining lymph nodes in non-small cell lung cancer patients treated with immunotherapy.

Eligibility criteria:
inclusion criteria: * willing and able to provide written informed consent for the study. * ≥ 18 years of age on day of signing informed consent. * confirmed diagnosis of nsclc. * histological tumor biopsy for pd-l1 ihc assessment (dako assay) available. * ipsilateral hilar or mediastinal lymph node with a short axis diameter ≥1 cm. * eligible and planned to receive nivolumab according to ema label and national guidelines. * measurable disease according to recist v1.1. * who performance status of 0-2. exclusion criteria: * has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to baseline pet-scan. * has an active infection or had an active infection within 2 weeks prior to baseline pet-scan. * has a known history of hypersensitivity to contrast material. * isolated distant relapse after curative intent treatment for stage i-iii nsclc.

Keywords: pd-l1 expression eligible for treatment with nivolumab
effect of cytokine-induced killer cells for advanced malignant gliomas

Conditions: Cytokine-Induced Killer Cells; Advanced Milignant Gliomas

Summary: the purpose of this study is to determine whether combining of temozolomide and cytokine-induced killer cells (cik) transfusion can prolong survival of patients with advanced malignant gliomas. the effectiveness and safety of cik cells for the treatment of malignant glioma is also evaluated.


Eligibility criteria:
inclusion criteria: * subjects with documented histologically confirmed primary grade 4 advanced malignant glioma. * no more than 3 prior relapses or prior systemic treatments. * recurrent disease documented by mri after prior therapy. * must have at least one site of bidimensionally measurable disease: archived tissue from the initial diagnosis of advanced malignant glioma or upon transformation to advanced malignant glioma are available for central review within approximately 4 weeks after enrollment. * completed at least one full cycle of temozolomide of 200 mg/m2/day administered on days 1-5 of a 28-day cycle, without unacceptable toxicity or progression. * karnofsky performance status of 60 or more. adequate organ and bone marrow function as defined by hematological and serum chemistry limits. * at least 18 years old. * both men and women must practice adequate contraception. * informed consent. exclusion criteria: * progressed while on temozolomide. * evidence of acute intracranial or intratumoral hemorrhage \> grade 1. * not recovered from the toxic effects of prior therapy. * pregnant or breast feeding. * history of diabetes mellitus. * uncontrolled intercurrent illness. * congestive heart failure, unstable angina, or a myocardial infarction within 3 months of entering the study. * hiv positive. * diagnosis of another malignancy may exclude subject from study.

Keywords: cytokine-induced killer cells milignant gliomas temozolomide
observatory of anticoagulation after bioprosthetic aortic valve replacement

Conditions: Aortic Valve Disease

Summary: the bioprosthetic aortic valve replacement is a frequent intervention because of the predominance of calcified aortic stenosis, which is the most common valvular disease, and aging of the population. international guidelines recommend anticoagulant therapy during the 3 postoperative months, but the risk-benefit ratio of anticoagulation post-operatively is questioned because of the low level of evidence available studies and their sometimes conflicting conclusions. questionnaires sent to practitioners have highlighted discrepancies between common practices and recommendations. however, there is no analysis of actual patterns of postoperative anticoagulation after aortic valve replacement with bioprosthesis. the aim of the arva observatory is to establish a cohort of 600 patients enrolled in 3 months and had a bioprosthetic aortic valve replacement in one of the 22 surgical centers french.

the study will include consecutive patients who agreed to participate in the study, which meet the criteria for inclusion, that is to say consecutive patients operated on by a bioprosthetic aortic valve replacement during the 3 months of inclusion. patients will be included immediately after completion of aortic valve replacement. the data will be entered directly by the referent of each center, based on data from the french society of cardiology accessible by internet on a secure site. the follow-up time will be 6 months the incidence of thromboembolic complications and bleeding and mortality within 6 months will be analyzed in a standardized manner according to the recommendations on the analysis of morbidity and mortality after valve surgery.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years old * patients operated on for single bioprosthetic aortic valve replacement during the study period: * with or without reinforcement * with or without associated cabg * with or without action on the ascending aorta * whether a first intervention or reoperation * patients who agreed to participate in the study exclusion criteria: * replacement aortic valve homograft or autograft * surgical procedures on another valve (conservative or prosthetic replacement) * permanent atrial fibrillation * processing anticoagulant vitamin k-long course

Keywords: aortic valve replacement bioprosthetic
personalized therapy in non-small cell lung cancer

Conditions: Lung Cancer; Carboplatin Adverse Reaction

Summary: excision repair cross complementing 1 (ercc1) ribonucleotide reductase m1 (rrm1) and thymidylate synthase(ts) are molecular determinants that predict sensitivity or resistance to platinum agents 、 gemcitabine and pemetrexed respectively. tailored therapy using these molecular determinants suggested patient benefit in a previously reported phase 2 trial. here, we designed a study for an individual patient analysis of prospectively accrued patients who were treated with the "personalized therapy" approach versus other standard approaches.

patients who had nonsmall- cell lung cancer (nsclc) performance status of 0/1 were accrued to 2 phase 2 clinical trials trial a (carboplatin and chemotherapy individuation based on sensitivity marker ), trial b (carboplatin non-individuation or chemotherapy non-individuation ). patients who were treated on trials b were analyzed as the "standard therapy" group. patients accrued to trial a were called the "personalized therapy" group. disease free survival (dfs) was estimated using the kaplan-meier method.

Eligibility criteria:
inclusion criteria: 1. histologically confirmed non-small cell lung cancer 2. age from 18 years to 75 years 3. ecog performance status no more than 2 4. at least one appraisable lung focus of diameter≥ 10 mm by lung ct 5. haemoglobin ≥10.0 g/dl, absolute neutrophil count ≥(anc) 1.5 x 109/l, platelets ≥100 x 109/l 6. total bilirubin ≤1.5 x upper limit of normal (uln) 7. alt and ast \< 2.5 x uln in the absence of liver metastases, or \< 5 x uln in case of liver metastases 8. creatinine clearance ≥60ml/min (calculated according to cockcroft-gault formula) 9. informed consent should be obtained before treatment. exclusion criteria: 1. mixed non-adenocarcinoma cell lung cancer histology 2. previous treatment for systemic chemotherapy or local radiotherapy 3. be allergic to chemotherapy drugs 4. second active primary malignancy or serious concomitant medical disease 5. difficulties with adequate follow-up

Keywords: lung cancer gemcitabine carboplatin pemetrexed
the role of glutathione deficiency and msids variables in long covid-19

Conditions: COVID-19

Summary: the purpose of this research study is to assess if glutathione, along with nac (n-acetyl cysteine) and alpha lipoic acid (ala), can help reverse some of the covid long-haul symptoms.subjects will be randomized in to one of two groups. depending on the group they are randomized in to, subjects will be taking either a combination of nac, alamax cr, and liposomal gsh or the same three nutritional supplements with a multivitamin and magnesium. regardless of the group, subjects will be asked questions to assess their covid symptoms, physical and mental health status. they will also be asked to take blood samples.


Eligibility criteria:
inclusion criteria: • patients with positive covid testing (ab, rt pcr) and mild-severe symptoms based on covid symptom list exclusion criteria: • history of a severe sulfa sensitivity (i.e., anaphylaxis, stevens johnson syndrome), allergy to meat products and/or gelatin (alpha gal allergy) and/or a history of an allergic or adverse reaction to nac, alpha lipoic acid and/or gsh.

Keywords: covid-19 long-haul
regression of cervical precancerous lesions and associated risk factors

Conditions: Cervix Uteri SIL; HPV; CIN2; CIN3

Summary: the aim of this study is to assess the extent of histopathological regression of severe cervical precancerous lesions (cin 2 and cin 3); evaluate the proportion of patients who experience the normalization of hpv test and cytology finding among those who were treated conservatively and those who underwent conization; and identify predictive parameters associated with regression. based on this analysis, a model will be proposed to predict the likelihood of lesion regression.

introduction there are three grades of dysplasia of the cervix based on their severity (cin 1-3). most women with cin 2 or cin 3 (high-grade - hg lesions) are referred for conization due to the presumed risk of developing invasive cervical cancer. however, this surgical intervention is associated with an increased risk of preterm labor in the future. from the literature, it is evident that 30% - 60% of cin 2 and cin 3 lesions spontaneously regress. colposcopic examination is a tool that can accurately assess the severity of the lesion and safely evaluate the dynamics of its development. it can be used to exclude the presence of invasive cervical cancer. the aim of the study is to determine the absolute rate of spontaneous regression of hg lesions, considering stratification factors. methods patients meeting all inclusion criteria and none of the exclusion criteria are included (see below). colposcopic evaluations occur at four-month intervals during the study. in case of progression, the patient is indicated for conization; in case of persistence, the patient is consulted and can choose further observation or conization; in case of regression, punch biopsy is performed to acquire a histopathologic sample for primary endpoint evaluation. the biopsy/conization result is subsequently compared with the initial sample to declare regression or persistence of the hg lesion. the hpv status and cytological findings are evaluated similarly. stratification criteria such as age, colposcopic characteristics, hpv genotype (cobas 4800, roche molecular systems, pleasanton, usa), methylation markers (gyntect®, oncgnostics gmbh, löbstedter str. 41, 07749 jena, germany), semiquantitative microscopic assessment of the vaginal swab, and personal history are assessed during monitoring.

Eligibility criteria:
inclusion criteria: 1. squamocolumnar junction fully visualized 2. bioptically verified cin 2 or cin 3 3. age ≥ 18 years 4. age ≤ 40 years 5. informed consent exclusion criteria: 1. squamocolumnar junction not fully visualized 2. suspicion on glandular lesion 3. suspicion on invasive cancer 4. personal history of cin 2, 3 or cerv. cancer 5. gravidity 6. hiv positivity 7. immunosuppression 8. impossible photographic documentation
a clinical trial of the orelabrutinib in the management of refractory itp

Conditions: Immune Thrombocytopenia; Bruton's Tyrosine Kinase

Summary: btk participates in a variety of signal transduction of innate and adaptive immunity, and has an important role in cell proliferation, differentiation and apoptosis. the impact of btk inhibitors on hematological malignancies and autoimmune diseases has been well studied. this project was undertaking by qilu hospital of shandong university in china. in order to report the efficacy and safety of the selective btk inhibitor orelabrutinib in the management of refractory itp.

the investigators are undertaking a prospective, open-lable, multicentre trial of 40 refractory itp adult patients in china. eligible participants will receive orelabrutinib in 50 mg po. qd, every 4 weeks for one cycle and it will be given 3 cycles. for non-responders who were well tolerated at 12 weeks of follow-up, the treatment could be extended to 6 cycles. the treatment will be discontinued after 6 months without blood index reaction. in order to report the efficacy and safety of orelabrutinib in the management of refractory itp, platelet count, bleeding and other symptoms will be evaluated before and after treatments. adverse events are also recorded throughout the study.

Eligibility criteria:
inclusion criteria: * meet the diagnostic criteria for primary immune thrombocytopenia * to show a platelet count \< 30 \* 10\^9/l, or with bleeding manifestations, or both * willing and able to sign written informed consent * meet the diagnostic criteria of refractory itp according to chinese guidelines exclusion criteria: * secondary thrombocytopenia * severe immune-deficiency or history of primary immunodeficiency * active or previous malignancy * hiv virus infection, tuberculosis, or other active infection (sepsis, pneumonia, or abscess) * pregnancy or lactation * diabetes * hypertension * cardiovascular diseases * severe liver or kidney function impairment * psychosis * osteoporosis * inflammatory bowel disease or gastric disease * arterial or venous thromboembolism within the 6 months before screening or patients who required anticoagulant treatment * an organ or haematopoietic stem-cell transplantation * neutrophil count of less than 1500 cells per mm³; glycosylated haemoglobin less than 8%; partial thromboplastin time 1∙5 times or less the upper limit of normal (uln) * clinical electrocardiogram changes * neoplastic disease within the past 5 years * corrected qt interval greater than 450 ms for men and greater than 470 ms for women; * substance misuse within the previous 12 months; and those who could not adhere to the protocol or were planning to have a surgical procedure in 6 months.

Keywords: orelabrutinib
efficacy and safety of red ginseng concentrated powder on improvement of blood triglyceride level

Conditions: Hyperlipidemias

Summary: this study was conducted to investigate the effects of daily supplementation of red ginseng concentrated powder on improvement of blood triglyceride level.

this study was a 12-week, randomized, double-blind, placebo-controlled 2x2 cross-over design human trial. 50 subjects which of 25 by group were randomly divided into red ginseng concentrated powder and a placebo group.(a total of 100 subjects completed the 2x2 cross-over study.)

Eligibility criteria:
inclusion criteria: * age 19-70 years with triglyceride 120-200 mg/dl exclusion criteria: * lipid lowering agent within past 6 months * those with clinically significant severe cardiovascular, endocrine, immune, respiratory, liver, biliary, renal and urinary tract, neuropsychiatry, musculoskeletal, inflammatory and hematologic and gastrointestinal disorders * persons with significant hypersensitivity reactions to ginseng and red ginseng * those with a history of gastrointestinal disorders (ex, crohn's disease) or gastrointestinal surgery (excluding simple cecal surgery or hernia surgery) that may affect the absorption of a product for clinical trials * those who have received antipsychotic medication within 2 months before screening * those with a history of alcoholism or substance abuse * those who participated in other clinical trials within 2 months before screening * laboratory test by show the following results * aspartate transaminase(ast), alanine transaminase(alt) \> reference range 3 times upper limit * serum creatinine \> 2.0 mg/dl * pregnancy or breast feeding * those who doesn't accept the implementation of appropriate contraception of a childbearing woman * principal investigator judged inappropriate for participation in study because of laboratory test result, etc.

Keywords: red ginseng concentrated powder hyperlipidemias clinical trial
a clinical study to assess the efficacy of cannabigerol in patients with active rheumatoid arthritis.

Conditions: Rheumatoid Arthritis; Inflammatory Disease

Summary: this is a single-group exploratory longitudinal prospective study lasting 8 weeks. the study aims to measure the efficacy of purified cannabigerol (cbg) in patients with active rheumatoid arthritis using laboratory and self-reported outcome measures.


Eligibility criteria:
inclusion criteria: * male or female, over 25 years of age * positive anti-ccp blood test * active ra-related inflammation with at least 2 swollen joints * university graduate * generally healthy with no uncontrolled chronic disease * able to read, understand, and sign informed consent * resides in the usa * willing to comply with study requirements and avoid other cannabis products during the study period exclusion criteria: * pre-existing chronic conditions preventing adherence * severe allergic reactions requiring an epi-pen * use of opiates in the last 4 weeks or cannabis in the last 8 weeks * pregnant or breastfeeding women * recent invasive medical procedure or surgery * active malignancy or ongoing oncology treatment * use of cytochrome p450 or 3a4 inhibitors * history of substance abuse

Keywords: arthritis treatment cannabinoid therapy anti-ccp
a phase 1 study of ljpc-501 in patients with hepatorenal syndrome

Conditions: Hepatorenal Syndrome Type I and Type II

Summary: hepatorenal syndrome (hrs) is a life-threatening condition marked by rapid decline in kidney function in patients with liver cirrhosis or fulminant liver failure. vasodilation in the gastrointestinal region is largely thought to contribute to the disease. ljpc-501 is a vasoconstrictor that may restore proper circulation and kidney function in patients with hrs.

vasoconstrictors are considered a promising approach to treat hrs due to the significant vasodilation of the splanchnic circulation that contributes to systemic arterial underfilling and leads to functional decline of the kidney in these patients. vasoconstrictors currently in use are associated with reduced organ perfusion and have marginal effect on sodium excretion. the vasoconstrictor angiotensin ii has been shown to produce significant sodium excretion and urine output in patients with cirrhosis and ascites, supporting its potential utility in the treatment of hrs.

Eligibility criteria:
inclusion criteria: 1. patients with hrs, as defined by the international ascites club \[1\]: * cirrhosis with ascites * serum creatinine \> 1.5 mg/dl * no improvement of serum creatinine (decrease to a level of ≤ 1.5 mg/dl) after at least 2 days with diuretic withdrawal and volume expansion with albumin * absence of shock * no current or recent treatment with nephrotoxic drugs * absence of parenchymal kidney disease, as indicated by proteinuria \> 500 mg/day, microhematuria (\> 50 red blood cells per high power field) and/or abnormal renal ultrasonography or patients with hrs due to acute alcoholic hepatitis 2. patient is able to undergo a reliable neurologic exam, as determined by the investigator 3. patient or legal surrogate is willing and able to provide written informed consent 4. patient is willing and able to comply with all protocol requirements exclusion criteria: 1. evidence of shock 2. current or recent treatment with nephrotoxic drugs 3. use of midodrine, octreotide, or other vasopressors within 48 hours of screening 4. current treatment with dialysis 5. serum creatinine \> 7 mg/dl 6. active cardiovascular disease within 3 months of screening 7. history of transient ischemic attacks or prior stroke 8. history of organ transplant 9. ongoing infection requiring intravenous administration of antibiotics (patients with documented infections considered by the investigator to be controlled within 48 hours of screening may be permitted in the study upon consultation with the sponsor's medical monitor) 10. participation in a clinical trial within 30 days of screening 11. patient unlikely to survive more than 72 hours in the opinion of the investigator 12. patient is pregnant or planning to become pregnant during study

Keywords: hepatorenal syndrome