Kornimate/medical-research-clean huggingface dataset:
fertility-sparing management using high-dose oral progestin in young women with endometrial cancer

Conditions: Endometrial Cancer

Summary: this registry aims to evaluate the efficacy of using high-dose oral progestin in young women with stage i endometrial adenocarcinoma with grade 2 differentiation or superficial myometrial invasion as a fertility-sparing management.

the standard treatment for endometrial cancer is total hysterectomy and bilateral salpingo-oophorectomy, peritoneal cytology, and lymph node dissection. however, young patients who desire to preserve their potential for fertility may find this standard treatment difficult to accept. therefore, the conservative treatment for these patients has remained a challenge. a number of studies have reported the effectiveness of hormonal therapy using systemic progestin in women clinically diagnosed with early endometrial adenocarcinoma at stage ia, grade 1, who want to maintain reproductive potential. however, there have been few prospective studies about hormonal therapy in young women with stage i endometrial adenocarcinoma with grade 2 differentiation or superficial myometrial invasion as a fertility-sparing management. \[primary endpoint\]: to evaluate the complete response rate \[sencondary endpoint\]: to evaluate of disease-free survival rate, fertility outcomes and side effects of high-dose oral progestin. to analyze predictive and prognostic biomarkers and clinicopathologic factors about response and recurrence after therapy, to analyze patient-reported outcomes. \[treatment methods\] patients with histologically confirmed grade 1 endometrioid adenocarcinoma with superficial myometrial invasion or patients with histologically confirmed grade 2 endometrioid adenocarcinoma that is presumably confined to the endometrium or patients with histologically confirmed grade 2 endometrioid adenocarcinoma with superficial myometrial invasion are administered medroxyprogesterone acetate(mpa) at a dosage of 500 mg/day for 12 months. follow-up and treatment response assessment were implemented at a 3-month interval with mri and dilatation and curettage (d\&c) procedure. the biopsy findings are compared. \[investigational product\] general name/brand name:farlutal tab. 500mg/ pfizer

Eligibility criteria:
inclusion criteria: * patients with histologically confirmed grade 1 endometrioid adenocarcinoma with superficial myometrial invasion based on magnetic resonance image(mri) * patients with histologically confirmed grade 2 endometrioid adenocarcinoma that is presumably confined to the endometrium based on mri * patients with histologically confirmed grade 2 endometrioid adenocarcinoma with superficial myometrial invasion based on mri * patients who desire to preserve fertility potential * patients signed the written informed consent voluntarily exclusion criteria: * patients who have severe underlying disease or complication * under treatment of metastatic cancer from other organs or less than 5 years after previous cancer therapy * acute liver disease or kidney disease * thrombosis or phlebothrombosis requiring treatment, hyperlipidemia, smoker

Keywords: medroxyprogestrone acetate
a study of the cypher sirolimus-eluting stent to treat bifurcation lesions.

Conditions: Coronary Artery Disease

Summary: the objective of this study is to assess the feasibility and safety of the sirolimus-coated bx velocity balloon-expandable stent in treating patients with true bifurcation lesions.

this is a prospective, randomized study that will be conducted at up to 5 centers in europe and the us. all patients who meet the eligibility criteria will be treated with the sirolimus-coated bx velocity balloon-expandable stent and stent delivery system (sds). as a secondary objective, patients will be randomized in a 1:1 ratio to receive one stent in the main branch with balloon angioplasty by a kissing balloon technique in the side branch (stent/ptca group), or to receive stents in both the main and side branches (stent/stent group). it is anticipated that up to 70% of the patients enrolled in the stent/ptca group will be considered treatment failures and require a stent in the side branch. these patients will have a sirolimus-coated stent placed in the side branch and will be followed per the protocol, but will be analyzed separately. therefore, it is anticipated that up to 75 patients will be enrolled in the trial. all patients will have repeat angiography at six months, with clinical follow-up to 5 years.

Eligibility criteria:
inclusion criteria: 1. has a diagnosis of angina pectoris as defined by canadian cardiovascular society classification (ccs i, ii, iii, iv) or unstable angina pectoris (braunwald classification b\&c, i-ii) or has documented silent ischemia; 2. involves a single treatment of a de novo bifurcation lesion in native coronary arteries of patients with single or multivessel disease; patients with multiple lesions can be included only if other lesions treated during the index procedure are successfully treated prior to the treatment of the bifurcation lesion; 3. has a true bifurcation lesion defined as stenosis \> 50% in both the main branch and the ostium of the side branch; 4. has a main branch vessel that is \<=2.5 mm and \<=3.5 mm in diameter by on-line qca proximal to the bifurcation; 5. has a side branch vessel that is \<=2.5 mm and \<=3.5 mm in diameter by on-line qca. exclusion criteria: 1. patient has experienced a q-wave or non-q-wave myocardial infarction with documented elevation of ck levels \> 2 times normal or ck-mb levels \> 3 times normal within the preceding 24 hours and/or the ck and ck-mb enzymes remain above normal at the time of treatment; 2. has unstable angina classified as braunwald a i-iii, or iii b or c, or is having a peri infarction; 3. has a bifurcation lesion in a non protected left main; 4. has an ejection fraction \<=35%; 5. there is presence of thrombus in the bifurcation lesion; 6. has a totally occluded vessel.
study of changes in csf ionic composition after aneurysmal meningeal hemorrhage

Conditions: Subarachnoid Hemorrhage

Summary: hyponatremia is a frequent complication of subarachnoid hemorrhage (sah) with a prevalence of 30 to 50% in patients with this condition. this hydro-electrolytic disorder is responsible for an increase in morbidity with the appearance of neurological disorders. also, it has been shown that there are ionic changes in the cerebrospinal fluid and a probable alteration of the blood-brain barrier in patients with sah. the kinetics and relationship between hyponatremia and these changes remain unknown. the main objective of the study is to determine whether the change in cerebrospinal fluid (csf) composition, precedes the development of hyponatremia. for this, the investigators propose to study the evolution of the csf ionogram with the blood ionogram. furthermore, they will perform additional analyses on the basis of a control group (csf of patient with normal pressure hydrocephalus) to determine the effect of sah on ionic changes. the hypothesis of the study is that there is a correlation between the change in csf blood ionogram and the development of hyponatremia between day 0 and day 14.


Eligibility criteria:
inclusion criteria: sah group : * adults * hospitalized in the neurological intensive care unit for a fisher modified aneurysmal sah 3 or 4 with evd and urinary catheter. * with a catheter (arterial or venous) for repeated sampling. control group : * adults * performing a perfusion test in the operating room for normal pressure hydrocephalus exclusion criteria: * patients with sah without evd. * patients with non-aneurysmal sah. * pregnant or breastfeeding women. * patients under legal protection, guardianship, curatorship, safeguard of justice. * patients participating in a study that may interfere with the present study. * persons under forced psychiatric care.

Keywords: subarachnoid haemorrhage cerebrospinal fluid ionic disorders hyponatremia normal pressure hydrocephalus blood-brain barrier ionogram
observational study of drowning patient's emergency care in its pre-hospital phase.

Conditions: Drowning

Summary: according to the 9th edition of "noyades" survey, 1480 drownings accidents occurred in france in 2021, of which 146 (i.e. nearly 10%), were in the var department. these patient's care involve in first place the emergency medical service (ems). to date, there is no recommendation from french or european academic societies of emergency medicine formalising pre-hospital care of these patients (except for the specific case of cardiac arrest). this absence of recommendation therefore favours heterogeneity of practices.

within a three-year period from 2019 to 2022, this retrospective observational study aims to provide an inventory of pre-hospital practices by the ems in the var department and to describe drowning patients' characteristics as well as their outcome, according to the initial regulation and the type of care. these data could help for pre-hospital care management.

Eligibility criteria:
inclusion criteria: 1. drowning patient 2. aged 18 years old or over 3. patient treated by pre-hospital care from the emergency medical services 83 (samu 83) between 1st january 2019 and 30th september 2022. exclusion criteria: 1. diving accident 2. patient opposition to participate in the study

Keywords: drowning emergency medical service pre-hospital care patient outcome
effect of treatment with egb 761(r) on blood markers of inflammation and oxidative stress in patients with mci

Conditions: Mild Cognitive Impairment (MCI)

Summary: mild cognitive impairment (mci) is the moderate impairment of a mental abilities to perform intellectual activities eg memory, calculation, communication... mci is a disorder that can occur earlier than dementia such as alzheimer's disease. it is believed that there are several factors involved such as inflammation and oxidative stress which is the production of reactive oxygen species that damage cells. this clinical study tries to evaluate that a treatment already approved by the aemps, egb 761® (tebofortan), could reduce the levels of markers of inflammation and oxidation in the blood.

this treatment is based on a plant called gingko biloba. in the study, half of the participants would be administered egb 761® during 24 months and the other half would not receive this treatment during 12 months and will received egb 761® for the next 12 months.

Eligibility criteria:
inclusion criteria: * criteria for mild cognitive impairment according to petersen. * global score deterioration scale (gds)=3 and clinical dementia rating (cdr)=0.5. * subject's ability to comply with study requirements in the opinion of the investigator. * informed consent signed exclusion criteria: * dementia (gds=4-7) severe auditory or visual abnormalities that could affect performance on neuropsychological tests. * severe psychiatric pathology. * hemorrhagic diathesis or anticoagulant treatment. * active treatment with anticholinesterase drugs or memantine. history of epilepsy or alcoholism. * galactose intolerance, malabsorption of glucose or galactose. * previous treatment with egb 761®.
study of hrs-5965 in healthy subjects and subjects with renal insufficiency

Conditions: Glomerulonephritis

Summary: the trial is the first human trial. the safety, tolerability, pk and pd of hrs-5965 tablets will be evaluated in healthy subjects and subjects with impaired renal function. the study was divided into three parts: part 1: single ascending dose, randomized, double-blind study，with 6 dose groups preset, of which 1 group will be administered under fasted and fed conditions; part 2: multiple ascending dose, randomized, double-blind study，with 4 dose groups preset; part 3: an open-label, nonrandomized, single-dose study to evaluate the effect of severe renal impairment (ri) on the safety, tolerability, pharmacokinetics, and pharmacodynamics of hrs -5965 compared to demographically-matched healthy participants with normal renal function.


Eligibility criteria:
inclusion criteria: - healthy subjects study 1. healthy male or female, age ≥ 18 years old and ≤ 70 years old (on the day of signing the informed consent); 2. 18.5kg/m2 ≤bmi\<30 kg/m2, and the weight of men should be ≥ 50kg, and that of women should be ≥ 45kg. study on subjects with renal insufficiency 1. age ≥ 18 years old and ≤ 70 years old (on the day of signing the informed consent), both men and women can; 2. 18.5kg/m2≤bmi\<30 kg/m2； 3. the estimated glomerular filtration rate of subjects with chronic renal insufficiency conforms to 15 ≤ egfr \< 30 ml/min/1.73m2 (calculated according to ckd-epi formula, see appendix 2 of the scheme). exclusion criteria: - healthy subjects study 1. the researcher has determined that there may be diseases or medical conditions that affect the absorption, distribution, metabolism and excretion of drugs or reduce compliance; 2. the estimated glomerular filtration rate conforms to egfr \< 90 ml/min/1.73m2 (calculated according to ckd-epi formula, see appendix 2 of the scheme); 3. according to the judgment of the researcher, any physiological or psychological disease or condition that may increase the risk of the test, affect the subject's compliance with the protocol, or affect the subject's completion of the test. study on subjects with renal insufficiency 1. those who received renal replacement therapy within 12 weeks before screening; or the two tests in the screening period indicate that the renal function is unstable (the results in the screening period meet the diagnostic criteria of 2012 kdigo acute renal injury, or the changes that do not meet the above criteria but are judged to be clinically significant by the researcher. if there are reasonable reasons, the third test is allowed, and the interval between two consecutive tests should be more than 3 days but not more than 7 days); 2. according to the judgment of the researcher, the subject has any of the following: in the state of progression or prognosis of disease (including primary renal disease, complications and other complications); the treatment plan needs to be adjusted at any time; any physical or mental disease or condition that may increase the risk of the test, affect the subject's compliance with the protocol, or affect the subject's completion of the test.
hpv specific immune lymphocytes (hpv-ctls) in the treatment of hpv

Conditions: Human Papilloma Virus

Summary: the purpose of this clinical trial is to evaluate the safety and efficacy of iv-infused autologous or allogenic hpv-ctls.

human papilloma viruses (hpv) have been consistently implicated in causing cervical cancer especially those high-risk types (hpv 16, 18, 31, 45). around 50-80% of women are infected by hpv within their whole lives. the current treatment of hpv-positive mainly includes drug, cryotherapy, laser, microwave, surgery and so on. some treatments are convenient, but easy to cause pain or infection and there is still a greater risk of recurrence after treatment. adoptive immunotherapy with cytotoxic t lymphocytes (ctls) reactive with specific viral antigens has proven to be effective. here, the investigators aim to evaluate the safety and efficacy of multiple infusions of hpv specific cytotoxic t lymphocytes cells in patients.

Eligibility criteria:
inclusion criteria: 1. written, informed consent obtained prior to any study-specific procedures. 2. evidence of hpv virus activation (viral dna) or high risk of hpv infection. 3. not suitable for routine treatment or invalid to antiviral drugs. 4. patients with viral disease symptoms and confirmed by biopsy, regardless of the level of virus dna. 5. age less than 75 years. 6. did not use penicillin or β-lactam antibiotics, or the lowest dose of other antibiotics. 7. initial hematopoietic reconstitution: neutrophils (anc) ≥ 1,000/mm\^3, platelet (plt) ≥ 1,000/mm\^3. 8. proper renal and hepatic functions (uln denotes "upper limit of normal range"): creatinine ≤ 2\*uln, bilirubin ≤ 2\*uln, sgot/ sgpt ≤ 3\*uln. 9. if hpv-ctl is not from the patient's own, then the provider of hpv-ctl needs to meet the following criteria: * did not receive chemotherapy or radiotherapy within 4 weeks prior to blood collection, and did not take any steroids for the previous week, did not use penicillin or β-lactam antibiotics, or the lowest dose of other antibiotics. * white blood cells ≥ 3,500 / μl, lymphocytes ≥ 750 / μl. 10. human immunodeficiency virus (hiv) test was negative. exclusion criteria: 1. subject or the donor of bmt recipient infected with hcv (hcv antibody positive), hbv (hbsag positive), hiv (hiv antibody positive), htlv (htlv antibody positive), treponema pallidum antibody positive or tb culture positive. 2. subject is albumin-intolerant. 3. subject with life expectancy less than 8 weeks. 4. subject participated in other investigational somatic cell therapies within past 30 days. 5. subject with positive pregnancy test result.

Keywords: human papilloma virus cytotoxic lymphocyte hpv-ctl
does perioperative goal directed therapy using flotrac improve outcomes in esophagectomy patients

Conditions: Esophageal Cancer

Summary: the objective of this prospective, randomized controlled study is to ascertain whether the perioperative use of the flotrac device to guide fluid and vasopressor management during esophagectomy improves patient outcomes. the primary outcome is cardiopulmonary complications; however, the secondary outcome of decreasing patient morbidity (acute renal injury, anastomotic leak, and overall length of both icu (intensive care unit) and hospital stay.


Eligibility criteria:
inclusion criteria: * patients 18 years of age or older * patients undergoing primary resection of esophageal cancer and resultant esophagectomy. exclusion criteria: * patients \ 140 kg, based on literature regarding accuracy of flotrac. * patients with sustained preoperative dysrhythmias, based on literature regarding accuracy of flotrac (atrial flutter and/or atrial fibrillation). * patients with diagnosed nyha class iii-iv failure or documented ef \< 30% * patients who are unable/unwilling to consent for study procedures
nepafenac opthalmic suspension 0.1% compared to acular ls for treatment of inflammation after cataract surgery

Conditions: Cataract

Summary: the purpose of this study is to compare the effectiveness of nepafenac ophthalmic suspension, 0.1% eye drops to acular ls eye drops, used before and after cataract surgery, for treating inflammation in the eye.


Eligibility criteria:
inclusion criteria: * planned cataract extraction with posterior chamber intraocular lens implantation exclusion criteria: * under 10
a phase 2a study of tpn-101 in patients with c9orf72 als/ftd

Conditions: Amyotrophic Lateral Sclerosis; Frontotemporal Dementia

Summary: this is a phase 2a study to assess the the safety and tolerability of tpn-101 in patients with amyotrophic lateral sclerosis (als) and/or frontotemporal dementia (ftd) associated with hexanucleotide repeat expansion in the c9orf72 gene (c9orf72 als/ftd).

this is a phase 2a multi-center, randomized, double-blind, placebo-controlled parallel-group, 2-arm study with a long-term, open-label treatment phase in patients with c9orf72 als and/or ftd. this study includes a 6-week screening period, a 24-week double-blind treatment period, a 24-week open-label treatment period, and a follow-up visit 4 weeks post-treatment.

Eligibility criteria:
inclusion criteria: * documentation of a clinical genetic test demonstrating a hexanucleotide repeat expansion (hre) in the c9orf72 gene * has a reliable caregiver/informant to accompany the patient to all study visits for patients with als (with or without ftd): * diagnosis of als (probable, possible, laboratory-supported probable or definite) according to the world federation of neurology revised e1 escorial criteria * onset of weakness within 3 years prior to screening * slow vital capacity (svc) ≥ 60% of predicted normal adjusted for sex, age, and height (from the sitting position) * able to perform reproducible pulmonary function tests. * als functional rating scale-revised (alsfrs-r) ≥ 30 and score of 3 or 4 on item #3 (swallowing) at screening for patients with ftd: * a gradual, progressive decline in behavior, language, or motor function consistent with mild cognitive impairment, mild behavioral impairment, mild cognitive/behavioral impairment, behavioral variant ftd, primary progressive aphasia, or amnestic syndrome * cdr dementia staging instrument plus national alzheimer's coordinating center behavior and language domains (cdr plus nacc ftld) global score of 0.5-2.0 at screening exclusion criteria: * presence of other significant neurological or psychiatric disorders * history of clinically significant brain abnormality * clinically significant medical illness * tracheostomy or diaphragmatic pacing * autoimmune disease requiring treatment or management (quiescent rheumatoid arthritis, psoriasis, or controlled type 1 diabetes are acceptable) * history of human immunodeficiency virus (hiv) or hepatitis b infection, or any active infection during screening, unless the patient will have been symptom-free for at least 30 days prior to randomization

Keywords: als ftd
the use of immunohistochemical staining for the prediction of wilms tumour progression and recurrence

Conditions: Wilms Tumor; Relapse; Death

Summary: wilms' tumour staging and grading are used to give an idea about the prognosis. advanced staging, diffuse anaplasia, predominant blastemal elements and lymph node invasion are indicators of poor prognosis. in spite of using the previously mentioned parameters, some tumours which were considered of low risk did not respond to therapy and eventually resulted in mortality. in contrast, other tumours assumed to be of poor prognosis responded dramatically to treatment. in light of the above, it is crucial to search for predictors of wilms' tumour prognosis other than tumour staging and grading. many immunohistochemical (ihc) stains have been studied as prognostic markers for nephroblastoma in literature.

p53 is a tumour suppressor gene, and its mutation is identified in various types of human cancer. p53 protein accumulation in certain tumours is associated with tumour aggressiveness. the role of p53 expression in wilms' tumour is not clear; however, most studies confirmed its correlation with advanced stages and anaplasia. ki67 is a nuclear antigen related to cell proliferation, and high ki67 proliferation index (pi) is accompanied by tumour aggressiveness, distant metastasis and death. advanced stages and clinical progression of wt were found to be associated with high ki67 pi. on the other hand, some authors concluded that it may not be a dependable prognostic marker. the cyclin-dependent kinases (cdks) have a role in transitions between cell cycle phases with the need of cyclins association for their activity. ihc assessment of cell cycle proteins has a diagnostic use in histopathology. correlation between poor prognosis and overexpression of cyclin a was confirmed in different entities of human cancer such as medulloblastoma and ovarian carcinoma. a recent study deduced that cyclin a overexpression may be associated with the poor prognosis of wt.

Eligibility criteria:
inclusion criteria: * all children presented with wilms' tumour at the urology and nephrology center, mansoura university, mansoura, egypt from 2000 to 2014. exclusion criteria: * preoperative chemotherapy (due to areas of necrosis and haemorrhage hindering immunohistochemical staining). * patients with incomplete follow-up data.