Kornimate/medical-research-clean huggingface dataset:
efficacy and safety of alirocumab (sar236553/regn727) versus ezetimibe on top of statin in high cardiovascular risk patients with hypercholesterolemia (odyssey combo ii)

Conditions: Hypercholesterolemia

Summary: alirocumab (sar236553/regn727) is a fully human monoclonal antibody that binds pcsk9 (proprotein convertase subtilisin/kexin type 9). primary objective of the study: to demonstrate the reduction of low-density lipoprotein cholesterol (ldl-c) by alirocumab as add-on therapy to stable maximally tolerated daily statin therapy in comparison with ezetimibe after 24 weeks of treatment in participants with hypercholesterolemia at high cardiovascular (cv) risk. secondary objectives: * to evaluate the effect of alirocumab in comparison with ezetimibe on ldl-c at other time points * to evaluate the effect of alirocumab on other lipid parameters * to evaluate the safety and tolerability of alirocumab

the maximum study duration was 115 weeks per participant, including a 3-week screening period, 104-week randomized treatment period and 8-week follow-up period.

Eligibility criteria:
inclusion criteria: participants with hypercholesterolemia and established coronary heart disease (chd) or chd risk equivalents who were not adequately controlled with a maximally tolerated daily dose of statin at stable dose for at least 4 weeks prior to the screening visit (week -2). exclusion criteria: * age \< 18 or legal age of adulthood, whichever was greater * participants without established chd or chd risk equivalents * ldl-c \<70 mg/dl (\<1.81 mmol/l) and participants with a history of documented cardiovascular disease * ldl-c \<100 mg/dl (\<2.59 mmol/l) and participants without a history of documented cv disease * fasting serum triglycerides \>400 mg/dl (\>4.52 mmol/l) the above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
the early coagulopathy for the prognosis in sepsis

Conditions: Sepsis; Coagulopathy; Outcome, Fatal

Summary: in this cohort study, the parameters (tm, tat, pic, tpaic, et al.) associated with the hemostatic system will be collected in sepsis patients when admitted to the intensive critical unit. parameters will be evaluated for their prognostic function of 28 days mortality.

the object of this study is to find the early mortality prognostic biomarkers within the hemostatic system in sepsis patients. blood samples will be collected from sepsis patients at admission. parameters reflect endothelial injury, such as thrombomodulin (tm), tissue type plasminogen activator inhibitor complex (tpaic), parameters reflect procoagulation condition, such as thrombin-antithrombin complex (tat), and parameters reflect hyperfibrinolysis, such as plasmin-plasmin inhibitor complex (pic) will be tested. based on the results of these parameters, sepsis patients will be divided into coagulation parameter normal or abnormal groups. twenty-eight days of mortality will be determined by patient follow-up. regression analysis will be used to evaluate the relationship between these parameters and the mortality of sepsis patients.

Eligibility criteria:
inclusion criteria: * patients admitted to icu of union hospital, tongji medical college, huazhong university of science and technology from august 2020 to july 2022. * patients diagnosed with sepsis. the criteria for diagnosis is: 1. infection or suspected infection; 2. sofa score ≥ 2. * age interval: 18 years -- 80 years. * gender: unlimited. * signed informed consent form received. * results of the coagulation parameters tested within 24 hours after admission are available. exclusion criteria: * pregnant and lactating women. * with primary diseases that can cause thrombocytopenia or prolong prothrombin time, such as leukemia. * patients with severe liver dysfunction. * patients with anticoagulation or fibrinolysis medications within 72 hours before admission. * patients are in a procoagulation condition, such as vte patients, protein c or protein s deficient individuals. * patients with chronic renal failure. * patients need ecmo therapy. * patients with severe cardiopulmonary diseases or nervous system diseases. * patients at the end-stage of disease. * patients without signed informed consent forms.

Keywords: sepsis thrombomodulin thrombin-antithrombin complexe plasmin-α2-plasmin inhibitor complex tissue plasminogen activator-plasminogen activator inhibitor-1 complex mortality
research into the molecular bases of a new phenotype combining premature white hair, polycystic kidney disease, aortic dilation/dissection and lymphopenia

Conditions: New Phenotype (Combining Premature White Hair, Polycystic Kidney Disease, Aortic Dilation/Dissection and Lymphopenia)

Summary: this study involves a single family, including 1 patient, father, mother and sister. the patient presented with a new phenotype associating premature white hair, renal polycystosis, aortic dilation/dissection and lymphopenia. samples were taken in order to identify the origin of the symptomatology highlighted in the index case. in addition, it was observed that mice invalidated for bcl-2, normal at birth and indistinguishable from control mice, showed, after one week, a phenotype similar to that observed in this patient. the overlap between the patient's main clinical signs (lymphopenia, white hair and polycystic renal disease) and the manifestations presented by the invalidated murine model for bcl2 suggests that its phenotype may be secondary to a bcl-2 expression defect.


Eligibility criteria:
this study involves a single family, including 1 patient, father, mother and sister.
special investigation in patients with rheumatoid arthritis (working productivity activity impairment)

Conditions: Rheumatoid Arthritis

Summary: this is a single-arm, multi-center, prospective cohort study (post-marketing observational study). the observation period for each participant is 48 weeks. this study is designed to provide additional data on treatment effects of adalimumab during 48 weeks of treatment in patients with ra under conditions of routine rheumatology care. course of work productivity and work ability, the course of health-related quality of life, and changes in functionality during 48 weeks treatment with adalimumab are to be documented.

this study was designed as a non-interventional observational study. adalimumab was prescribed in the usual manner in accordance with the terms of the local market authorization with regards to dose, population and indication as well as local guidelines.

Eligibility criteria:
inclusion criteria: ra patients treated with adalimumab who satisfied the following conditions: 1. paid worker (pw) ra patients who are engaged in paid work for more than 35 hours per week 2. home worker (hw) * category 1 unpaid workers; ra patients who are engaged in paid work for less than 35 hours per week * category 2 unpaid workers; ra patients who perform basic activities of daily life (household duties, shopping, child caring, exercise, study, etc.) other than pw exclusion criteria: 1. ra patients showing lowered basic activities of daily life, such as hospitalization and being bedridden 2. ra patients with a history of previous treatment with adalimumab

Keywords: rheumatoid arthritis
relmacabtagene autoleucel in hematologic malignancies

Conditions: Lymphoma, B-Cell; Large B-cell Lymphoma; Follicular Lymphoma

Summary: to evaluate the efficacy and safety of relmacabtagene autoleucel in the treatment of adult patients with hematologic malignancies in real-world

the purpose of this study is to observationally evaluate the efficacy and safety data of relmacabtagene autoleucel for the treatment of patients with hematologic malignancies for up to 15 years after infusion. the treating physician will determine the most appropriate diagnostic and therapeutic regimen for the patient based on clinical practice. no therapeutic intervention will be administered to patients in this study.

Eligibility criteria:
inclusion criteria: 1. signed informed consent 2. patients who have been treated with relma-cel, including those who have received off-label products; 3. if previously enrolled in another clinical study, they must have completed follow-up in the previous study, or have withdrawn or lost follow-up in the previous study. exclusion criteria: 1.patients who have been treated with relma-cel and then have been treated with other car-t products.

Keywords: relmacabtagene autoleucel chimeric antigen receptor t cells
identification of prognostic factors and role of radiotherapy in patients with ewing sarcoma

Conditions: Ewing Sarcoma

Summary: assess whether there is a correlation between some factors (age, sex, tumor volume, tumor site, chemotherapy-induced necrosis, radiation and biomarkers) and overall survival (os) and relapse-free survival (rfs) in patients with ewing sarcoma. identification of reliable prognostic factors could help to identify high-risk patients, which may require a different treatment and follow up.


Eligibility criteria:
inclusion criteria: * male and female patients treated at rizzoli orthopaedic institute between 01/01/1991 and 31/12/2021 * age ≥ 2 years * diagnosis of ewing sarcoma * patients with available clinical and imaging data exclusion criteria: * at least one inclusion criterion not met
triphasic osteochondral scaffold for the treatment of the ocd of the knee: observational study

Conditions: Osteochondritis Dissecans Knee

Summary: the objective of the present study is to evaluate the clinical results of reconstructive treatment of knee ocd defects treated with osteochondral scaffolds implanted with specific instrumentation.the evaluation will be performed through clinical, subjective and objective assessments.

30 patients affected by ocd of the knee will be included in observational, perspective, monocentric trial. patients will undergo clinical follow-up visits and administration of questionnaires before surgery and at 6, 12, 24 and 60 months after surgery. a crf (case report form) related to the patient's specific evaluation will be completed for each visit. patients will also have imaging (mri) examinations before surgery and at 12, 24 and 60 months after surgery as per normal clinical practice. evaluation of the quality of cartilage repair will be assessed by specific mri radiographic scores.

Eligibility criteria:
inclusion criteria * male or female patients, aged 15-40 years; * single symptomatic osteochondral injury from ocd classified as icrs ocd iii or iv at the level of the femoral condyles; * failure of conservative treatment * lesion size between 1 and 10 cm2; * bmi ≤ 30; * ability and consent of patients to actively participate in the rehabilitation protocol and clinical and radiological follow-up. exclusion criteria: * -additional grade iii or iv cartilage injury on the knee being treated; * advanced osteoarthritis * systemic or localized infection * systemic (e.g. rheumatoid arthritis) or local (e.g. synovitis) inflammatory diseases and cardiovascular diseases * immune system disorders * degenerative or vascular bone pathology (e.g. osteonecrosis) * coagulation disorders * systemic conditions that alter wound healing * established allergy to equine collagen and calcium phosphate salts * presence of ligamentous/patellofemoral instability/malignment, varus or valgus malalignment ≤ 3° that cannot be treated/corrected simultaneously; * previous tendon repair, ligamentous reconstruction, or realignment procedures within the past 12 months; * presence of any known human immunodeficiency virus, hepatitis, syphilis, malignant neoplasms and ongoing anti-neoplastic chemotherapy and radiation treatment; uncontrolled diabetes; uncontrolled thyroid function changes; uncontrolled metabolic disorders; renal disease and hypercalcemia * uncooperative patients, including those with a history of alcohol and drug abuse; participation in another clinical trial or medical device trial that clinically interferes with the present pilot study; * incapacitated patients; * pregnant or lactating women. in particular, in the case of a suspected pregnancy in a patient of childbearing age, this will be excluded by serological testing (hcg).

Keywords: knee ocd osteochondritis dissecans scaffold maioregen biomimetic osteochondral lesions
intrathrombus thrombolysis versus aspiration thrombectomy during primary pci

Conditions: Acute Coronary Syndrome; ST Elevation Myocardial Infarction; Percutaneous Coronary Intervention

Summary: this is an multicenter, randomized, controlled, parallel group study. st-segment elevation myocardial infarction (stemi) patients with high thrombus burden(htb) will be allocated to one of the following: intrathrombus thrombolysis or manual aspiration thrombectomy during primary percutaneous coronary intervention(ppci).

the hypothesis for attractive trial is that the intrathrombus thrombolysis with microcatheter or pierced balloon compared to manual aspiration thrombectomy will reduce the incidence of major adverse cardiovascular events(maces), including cardiovascular death, recurrent myocardial infarction, cardiogenic shock, or heart failure rehospitalization, stent thrombosis and target-vessel revascularization at 1 year in stemi patients with htb undergoing ppci.

Eligibility criteria:
inclusion criteria: 1. patients presenting with: * symptoms of myocardial ischemia lasting for ≥ 30 minutes and * definite ecg changes indicating stemi: st elevation of greater than 0.1 mv in two contiguous limb leads or 0.2 mv in two contiguous precordial leads 2. referred for ppci 3. within 12 hours of symptom onset, or 12-24 hours but still suffered from persistent symptom, hemodynamic instability or fatal arrhythmia 4. high thrombus burden: * timi thrombus grade 3 or 4 after emergency coronary angiography * or timi thrombus grade ≥3 after guidewire crossing or 1.5mm-diameter predilating the culprit lesion if emergency coronary angiography shows timi thrombus grade 5 5. informed consent exclusion criteria: 1. rescue pci after systemic thrombolysis 2. previous cabg history 3. life expectancy\<1 year 4. active bleeding in past 6 months, hemorrhagic disorders and prone to bleeding 5. serious hepatic or kidney dysfunction 6. pregnancy and lactation 7. uncontrolled hypertension (\>180/100mmhg) 8. previous hemorrhagic stroke or ischemic stroke in past 3 months 9. cardiogenic shock or cardio-pulmonary resuscitation 10. informed consent cannot be obtained or follow-up cannot be completed
eight-week efficacy & safety study of brisdelle™ (formerly known as mesafem) in the treatment of vasomotor symptoms associated with menopause

Conditions: Hot Flashes

Summary: this is an exploratory 8-week, multicenter, double-blind, randomized, placebo-controlled study of brisdelle (paroxetine mesylate) capsules 7.5 mgin subjects with moderate to severe postmenopausal vasomotor symptoms (vms), defined as follows: * moderate vms: sensation of heat with sweating, able to continue activity * severe vms: sensation of heat with sweating, causing cessation of activity

eligible subjects will be entered into a 1-week observation period followed by a 1-week run-in period. following completion of the run-in period, eligible subjects will be randomized to receive either brisdelle (paroxetine mesylate) capsules 7.5 mg or placebo in a 1:1 ratio. study drug will be administered once daily at bedtime. symptom assessment questionnaires will be administered at baseline and at day 28 and day 57 visits.

Eligibility criteria:
inclusion criteria: 1. female, \>40 years of age 2. reported more than 7-8 moderate to severe hot flashes per day (average) or 50-60 moderate to severe hot flashes per week for at least 30 days prior 3. spontaneous amenorrhea for at least 12 consecutive months 4. amenorrhea for at least 6 months and meet the biochemical criteria for menopause 5. bilateral salpingo-oophorectomy \>6 weeks with or without hysterectomy exclusion criteria: 1. history of hypersensitivity or adverse reaction to paroxetine mesylate 2. use of an investigational study medication within 30 days prior to screening or during the study 3. concurrent participation in another clinical trial or previous participation in this trial 4. family of investigational-site staff

Keywords: menopause vasomotor symptoms hot flash perimenopause nonhormonal therapies climacteric symptoms mesafem low-dose mesylate salt of paroxetine (ldmp)
zinc-l-carnosine prevents dysphagia in breast cancer patients undergoing adjuvant radiotherapy

Conditions: Breast Cancer Female; Dysphagia; Adjuvant Radiotherapy

Summary: irradiation of level iii and iv draining nodes in breast cancer patients is often associated with dysphagia, requiring treatment with fans and/or steroids. the present randomized phase iii trial determined whether zinc-l-carnosine ( hepilor), prevents or delays the onset of dysphagia in these patients.

. this is a randomized phase iii prospective placebo-controlled trial with patients recruited from one single university teaching hospital. inclusion criteria were: age ≥18 years, breast cancer patients who were candidates for post-operative rt by means of het to the breast /chest wall and sc/ic nodes (iii-iv levels).exclusion criteria were: pregnancy or lactation, known or suspected hypersensitivity or allergy to zlc or to any of the excipients in its oral solution. all patients were randomized by a pre-determined computer code to two groups. 1. hepilor arm: patients received zlc solution 2. placebo arm: patients received a placebo solution toxicity was assessed weekly in all patients immediately before or after the rt session. acute toxicity was defined as occurring during rt or in 30 days after it ended and assessed using the common terminology criteria for adverse events (ctcae 4.0 scale). dysphagia was assessed weekly by means of eat 10, a self-administered questionnaire

Eligibility criteria:
inclusion criteria: * age ≥18 years * breast cancer patients who were candidates for post-operative rt by means of het to the breast /chest wall and sc/ic nodes (iii-iv levels). exclusion criteria: * pregnancy or lactation * known or suspected hypersensitivity or allergy to zlc or to any of the excipients in its oral solution.
mirtazapine vs sumatriptan in the treatment of postdural puncture headache

Conditions: Headache

Summary: postdural puncture headache (pdph) is a potential complication after spinal anesthesia caused by traction on pain-sensitive structures from low cerebrospinal fluid pressure (intracranial hypotension) following a leak of cerebrospinal fluid at the puncture site. symptoms of this condition include a bilateral frontal or occipital headache that is worse in the upright position, along with nausea, neck pain, dizziness, visual changes, tinnitus, hearing loss, or radicular symptoms in the arms. this study will examine the efficacy of mirtazapine in in the treatment of pdph after obstetric surgery under spinal anesthesia and compared its efficacy with that of sumatriptan.


Eligibility criteria:
inclusion criteria: * asa i and ii patients. * patients undergoing obstetric surgeries under spinal anesthesia. and complaining from moderate-to-severe pdph after 25g or 27g spinal needle puncture. exclusion criteria: * refusal of the intervention or participation in the study. * patient under age of 18 years old. * psychiatric illness. * patients with a history of ischemic heart disease, pregnancy-induced hypertension, chronic hypertension, cardiac, vascular, liver or renal impairment. * patients with a history of migraine. * patients with known hypersensitivity to study drugs. * patients currently using ergotamine, monoamine oxidase inhibitors, or selective serotonin reuptake inhibitors.
safe discharge in lower gastrointestinal bleeding

Conditions: Lower GI Bleeding

Summary: the increasing incidence in lower gastrointestinal bleeding (lgib) leads to a rise in hospital admission. many lgbi are self-limiting thus the several scores to identify low risk patients suited to outpatient care have been described. we aim to compare two of this scores (oakland score and sha2pe score) in terms of performace to predict "safe discharge" from the emergency department.

the growing incidence of lower gastrointestinal bleeding (lgib) is leading to a rise in hospital admissions even though most lgib episodes are self-limiting. the oakland and sha2pe scores were designed to identify patients best suited to outpatient care. our aim is to validate the sha2pe score and compare both of these scores in terms of predictiveness of safe discharge. we conducted a retrospective observational study of lgib patients admitted to our hospital between june 2014-june 2019. during this period, data from all lgib episodes admitted from the ed were collected in an electronic anonymized database created specifically for this study. if any of the principal variables or critical information was missing, the patient was excluded from the study.

Eligibility criteria:
inclusion criteria: * all \> 18 year old patients, male and women, admitted to our hospital between june 2014 and june 2019 because of lgib (lower gastrointestinal bleeding). exclusion criteria: * patients in whom lgib occurred while already admitted for an other cause. * patients with lgib transferred from another hospital due to comorbidities or severity of the gastrointestinal bleeding episode. * patients with post-polypectomy lgib (endoscopic polypectomy \<14 days before admission). * patients with gastrointestinal bleeding of unknown origin after a complete study. * patients who had undergone digestive tract surgery in the previous month. * patients with an ostomy. * patients with known colorectal cancer who had not undergone surgery.

Keywords: discharge lower gastrointestinal bleeding oakland score sha2pe score
matrix metalloproteinases neutralizing agents in oral lichen planus

Conditions: Oral Lichen Planus

Summary: the current study will be conducted to evaluate the effectiveness of matrix metalloproteinases inhibitors on erosive oral lichen planus.

matrix metalloproteinases inhibitor (orochem) will be given to patients with oral erosive lichen planus three times daily for 3 weeks. then the subjective discomfort and pain severity as well as the objective disease severity scores will be collected.

Eligibility criteria:
inclusion criteria: * patients diagnosed with erosive olp confirmed with a biopsy. * patients should have symptomatic lesions exclusion criteria: * patients who were under anticoagulant medications, suffering from any systemic diseases or having any physical or mental abnormality, pregnant and lactating women, smokers.

Keywords: matrix metalloproteinase inhibitors, orochem, olp