Kornimate/medical-research-clean huggingface dataset:
chilled platelet study "chips"

Conditions: Acute Blood Loss

Summary: a phase 3 randomized partial blind storage duration ranging study in patients undergoing complex cardiac surgery that will compare the transfusion of cold stored platelets to standard room temperature stored platelets. the primary objective is to establish that cold stored platelets have a non-inferiority (or superiority) to room temperature platelets.


Eligibility criteria:
inclusion criteria: * viable neonates ≥ 3 kg at time of enrollment (as defined in section 4.1) or age greater than 28 days and less than 85 years of age at time of consent; and * planned complex cardiac surgery with planned use of cardiopulmonary bypass, with an expectation of bleeding requiring platelet transfusion. exclusion criteria: * expected order for washed or volume reduced platelets * patient with known anti-platelet antibodies * platelet transfusion refractoriness due to anti-hla antibodies * known or suspected pregnancy * previously randomized in this study * conscious objection or unwillingness to receive blood products * known iga deficiency * known congenital platelet disorder * known congenital bleeding disorder * planned post-operative extracorporeal membrane oxygenation (ecmo), ventricular assist device (vad), and/or continuous renal replacement therapy (crrt)/ hemodialysis * patients intended to receive whole blood either intra-operative or post-operative for bleeding * platelet transfusion (of any type) within 24 hours prior to the date of surgery * pre-operative thrombocytopenia, defined as platelet count \<75x10(9)/l, based on the most recent labs completed within 72 hours prior to the date of surgery.

Keywords: platelets cold-stored platelets bleeding hemostasis complex cardiac surgery
lisaftoclax (apg-2575) combined with azacytidine (aza) in the treatment of patients with higher-risk myelodysplastic syndrome (glora-4).

Conditions: Higher-risk Myelodysplastic Syndrome

Summary: a global multicenter, randomized, double-blind, placebo-controlled, pivotal phase iii study. to evaluate overall survival (os) of lisaftoclax (apg-2575) combined with azacitidine (aza) vs. placebo combined with azacitidine in newly diagnosed patients with hr-mds.

this study intends to enroll patients with hr-mds to receive the therapy of lisaftoclax (apg-2575) combined with azacitidine (aza) or placebo combined with azacitidine.

Eligibility criteria:
inclusion criteria: 1. newly diagnosed higher-risk mds. 2. ecog score of ≤2. 3. expected survival ≥ 3 months. 4. adequate organ function. 5. female subjects of potential childbearing potential have a negative urine or serum pregnancy test before dosing. subjects of childbearing potential as well as their partners voluntarily use contraception deemed effective by the investigator during the treatment period and for at least six months after the last dose of study drug. 6. able to understand and voluntarily sign a written informed consent form, which must be signed prior to the performance of any trial-specified study procedures. 7. subjects are able to complete study procedures and follow-up examinations. exclusion criteria: 1. concomitant other malignancies or prior malignancies with disease-free intervals of less than 1 year at the time of signing the informed consent. 2. have undergone hematopoietic stem cell transplantation. 3. uncontrolled active infection 4. use of moderately potent inducers and moderately potent inhibitors of cyp3a4 within 7 days prior to the first dose of study drug. 5. mds or other conditions that cannot be administered enterally. 6. any condition that the subject is deemed to be inappropriate to participate in this study after evaluation by the investigator.

Keywords: higher-risk myelodysplastic syndrome lisaftoclax
open versus endovascular repair of abdominal aortic aneurysms

Conditions: Abdominal Aortic Aneurysm Without Rupture

Summary: this is an observational retrospective cohort study of all patients consecutively submitted to elective abdominal aortic aneurysm surgery repair at a tertiary referral centre between 2009 and 2015. patients were excluded if they were non-elective cases or had complex aortic aneurysms (juxta-renal, thoraco-abdominal or thoracic). differences between both groups of repair were assessed, as well as short- and long-term complications including medical complications, duration of hospital stay, major cardiovascular events, mortality and vascular reintervention.


Eligibility criteria:
inclusion criteria: * this is an observational retrospective cohort study of all patients consecutively submitted to elective aaa surgery repair at a tertiary academic referral center from south europe, between january 2009 and december 2015. exclusion criteria: * the exclusion criteria were non-elective cases, aortic intervention due to diagnosis other than infrarenal aaa and complex aortic aneurysms such as juxta-renal, thoraco-abdominal or thoracic aneurysms.
circulating cathodic antigen test compared to microscopy for diagnosis of urinary schistosomiasis in sohag

Conditions: Urinary Schistosomiases

Summary: schistosomiasis is a chronic infection endemic in 74 tropical and sub-tropical countries. sub-saharan africa carries the highest burden (90%) of schistosomiasis which caused by both schistosoma mansoni and schistosoma haematobium. the prevalence of schistosomiasis should be assessed to control of the infection. this is usually achieved through surveys based on the use of traditional parasitological methods as urine filtration for s. haematobium. however, these traditional methods are time consuming, require an experienced technician and multiple samples due to light-infection and irregular shedding. therefore, the point-of-care circulating cathodic antigen (poc-cca) urine test has been developed for the diagnosis of s. haematobium infection which is simple, rapid, sensitive and specific assay.


Eligibility criteria:
inclusion criteria: * 100 outpatient children aged between 5 - 16 years exclusion criteria: * outpatient children should not have received schistosomiasis treatment (within the past 6 months) prior to the study
vibro-acoustography imaging in diagnosing breast masses in women with a breast mass or breast cancer

Conditions: Breast Cancer

Summary: rationale: new diagnostic procedures, such as vibro-acoustography imaging, may be an effective method of diagnosing breast cancer. purpose: this clinical trial is studying how well vibro-acoustography imaging works in diagnosing breast masses in women with a breast mass or breast cancer.

objectives: * to study in vivo detection of breast masses by vibro-acoustography (va) imaging. * to evaluate the performance of va imaging in differentiating between benign and malignant breast masses identified as bi-rads 4 or 5. outline: patients undergo clinical mammography of the breast, followed by vibro-acoustography (va) imaging using ultrasonography over 90 minutes. patients may also undergo further imaging using clinical ultrasonography.

Eligibility criteria:
disease characteristics: * suspiciuos breast lesions identified as bi-rads 4 or 5 and 3 * hormone receptor status not specified patient characteristics: * female * menopausal status not specified * not pregnant * no condition that does not allow proper use of study imaging devices prior concurrent therapy: * see disease characteristics

Keywords: stage i breast cancer stage ii breast cancer stage iiia breast cancer stage iiib breast cancer stage iiic breast cancer stage iv breast cancer
prostate cancer monitoring using [18f]dcfpyl and blood based biomarkers

Conditions: Metastatic Prostate Cancer

Summary: primary objective: * to determine whether changes in uptake of \[18f\]dcfpyl pet/ct scans at baseline and after 6 weeks of treatment for metastatic castrate resistant prostate cancer, correlates with radiographic progression free survival (rpfs) as defined by prostate cancer working group 3 (pcwg3) criteria. secondary objectives: * to determine whether changes in uptake of \[18f\]dcfpyl pet/ct scans correlate with overall survival (os) * to determine whether baseline suvmax correlate with rpfs * to compare number of lesions detected with standard imaging at baseline and at the time of progression

prostate cancer is the most common cancer and the third most common cause of cancer deaths in american men. the lethal form of the disease is metastatic castrate resistant prostate cancer (mcrpc). serum prostate specific antigen (psa) testing has been relied upon heavily as a marker of disease and is commonly used in the community to guide therapy. pyl, also known as \[18f\]dcfpyl, is a second-generation fluorinated prostate-specific membrane antigen (psma) targeted positron emission tomography (pet) imaging agent. in preliminary studies it demonstrates a higher detection of metastatic prostate lesions compared to standard imaging. however, the role of \[18f\] pyl in tumor response to therapy has not been evaluated, specifically the potential to serve as a predictive biomarker of response. given the high cost of current therapeutic agents in mcrpc, there is a need for an early response biomarker to stratify which patients will benefit from therapy and which will not. this will also allow for earlier change in management of patients who will not response to these therapies, potentially improving patient outcomes.

Eligibility criteria:
inclusion criteria: * histologically confirmed diagnosis of prostate cancer * age ≥ 18 years of age * eastern cooperative oncology group (ecog) performance status ≤ 2 (karnofsky ≥ 60%) * metastatic castrate resistant prostate cancer as defined by prostate cancer working group 3 * eligible to receive systemic treatment (abiraterone, enzalutamide, docetaxel, cabazitaxel) for their disease * ability to understand and willingness to sign a written informed consent document * wiling to comply with clinical trial instructions and requirements exclusion criteria: * history of another active malignancy within 3 years, other than basal cell and squamous cell carcinoma of the skin * presence of prostate brachytherapy implants * administration of another radioisotope within five physical half-lives of trial enrollment * radiation or chemotherapy within 2 weeks prior to trial enrollment * serum creatinine \> 3 times the upper limit of normal * serum total bilirubin \> 3 times the upper limit of normal * aspartate aminotransferase (ast) or alanine aminotransferase (alt) \>5 times the upper limit of normal * inadequate venous access
beta-1,3/1,6-d-glucan ganoderma lucidum on non-infectious and idiopathic uveitis

Conditions: Uveitis

Summary: to investigate the effect of beta-1,3/1,6-d-glucan from mycelium extract of indonesian ganoderma lucidum as an adjuvant to methylprednisolone for non-infectious and idiopathic uveitis

patients with non-infectious and idiopathic uveitis will receive standard treatment with methylprednisolone, but will be randomized to receive either beta-1,3/1,6-d-glucan from mycelium extract of indonesian ganoderma lucidum or placebo. follow up will be performed on week-2, week-4, week-6, month-2, and month-3. outcomes measured are anterior chamber cells, visual acuity, and serum tnf-alpha levels.

Eligibility criteria:
inclusion criteria: 1. patients with non-infectious and idiopathic uveitis. 2. indicated to receive oral steroid and have signs of anterior segment inflammation. 3. anterior chamber inflammation \>= +2 according to sun criteria. 4. age between 18 and 65 years old, good general condition, consented to be involved in the research, and are willing to come regularly according to follow up schedule. exclusion criteria: 1. received systemic steroid and/other immunosuppressive drugs two weeks before the start of the trial. 2. received antibiotics one week before the start of the trial. 3. contraindicated to oral steroid. 4. other primary ocular disorder, such as glaucoma, anterior segment dysgenesis, or others. 5. pregnant and nursing women. 6. patients with history of hypersensitivity/ allergy to ganoderma species or other fungi.

Keywords: non-infectious uveitis idiopathic uveitis
ruxolitinib as gvhd prophylaxis in aa patients

Conditions: The Prophylactic Value of Ruxolitinib for aGVHD in HSCT Recipients of AA

Summary: our study aimed to determine the prophylactic value of ruxolitinib for agvhd in hsct recipients of aa.ruxolitinib was initiated at the beginning of conditioning regimen at 5 twice daily until 3 months post-transplantation. the cumulative incidence of agvhd within 6 months after hsct will be the primary observation item.


Eligibility criteria:
inclusion criteria: * (1) diagnosed as aplasitic anemia, including v/saa,caa and haaa. (2) age elder than or equal to 14 years; (3) informed consent may be signed by themselves. (4) hiv negative, hbv, hcv negative; (5) informed consent must be signed before the start of the study procedures, and informed consent must be signed by the patient himself or his immediate family. considering the patient 's condition, if the patient' s signature is unfavorable for disease treatment, the informed consent form should be signed by the legal guardian or the patient 's immediate family member exclusion criteria: * (1) received a previous allogeneic hsct; (2) uncontrolled infection at enrollment; requires mechanical ventilation or is hemodynamically unstable at the time of enrollment; (3) has severe hepatic insufficiency (defined as child-pugh class c; has serum aspartate aminotransferase (ast) or alanine aminotransferase (alt) \> 5 xthe upper limit of normal (uln) or serum total bilirubin \> 2.5 x uln. (4) has end-stage renal impairment with a creatinine clearance less than 10 ml/min. (5) has both moderate hepatic insufficiency and moderate renal insufficiency; (6) has documented positive results for human immunodeficiency virus antibody (hivab), hepatitis c virus antibody (hcv-ab) with detectable hcv rna, or hepatitis b surface antigen (hbsag) within 90 days prior to enrollments; (7) has active solid tumor malignancies with the exception of localized basal cell or squamous cell skin cancer or the condition under treatment (e.g., lymphomas). (8) suffering from mental disorders or other conditions and unable to cooperate with the requirements of study treatment and monitoring; (9) unable or unwilling to sign the consent form; (10) patients with other special conditions assessed as unqualified by the investigator
an observational study on patients with non-squamous nsclc who reached a long pfs after avastin (bevacizumab)-based first-line therapy

Conditions: Non-Squamous Non-Small Cell Lung Cancer

Summary: this retrospective observational study will analyse demographic, clinical and treatment-related data of patients with non-squamous non-small cell lung cancer (nsclc) who had reached \>/= 9 months of progression-free survival after avastin (bevacizumab)-based first-line therapy. data will be collected for approximately 9 months.


Eligibility criteria:
inclusion criteria: * adult patients, \>/= 18 years of age * non-squamous non-small cell lung cancer (nsclc) treated with first-line avastin-based therapy * progression-free survival of \>/= 9 months reached exclusion criteria: * n/a
the use of he4 with simple ultrasound rules to predict malignancy in a pelvic mass

Conditions: Pelvic Mass

Summary: our objective is to determine if the combination of simple ultrasound features (iota simple rules) and a new biomarker (he4) together with a common tumour marker (ca 125) can accurately predict ovarian cancer in women found to have a pelvic mass on ultrasound. the investigators hypothesize that the use of two biomarkers (he4 and ca 125) in a mathematical algorithm (risk of malignancy algorithm, roma) can be used to predict malignancy in a pelvic mass which has indeterminate ultrasound features. this is a prospective cohort study involving women undergoing operation for a pelvic mass. 720 women scheduled to have an operation to remove a pelvic mass would be recruited from 3 hospitals (qmh, uch and pyneh). pre-operatively, each woman will have an ultrasound assessment using the iota simple rules criteria and have blood taken for tumour markers he4 and ca 125. in women where iota ultrasound rules are inconclusive, 2 strategies for prediction will be compared - calculation of risk by roma (strategy a) vs referral for an expert ultrasound (strategy b). these pre-operative risk predictions will be correlated with the final pathology found at the operations. main outcome measures include the sensitivity, specificity, positive and negative predictive powers for strategy a compared to strategy b. sensitivity and specificity will be compared using the mcnemar test. area under the roc curve (auc) will be calculated and compared using the delong method for the 2 strategies. the investigators expect auc of both strategies will be similar. this would suggest that roma can replace expert ultrasound in the pre-operative prediction of ovarian cancer.


Eligibility criteria:
inclusion criteria: * women over the age of 18 * found to have a pelvic mass on ultrasound, mri, ct or pet scan * scheduled for operation (laparoscopic or open) for a pelvic mass (including ovarian cystectomy and oophorectomy) * women who would understand the informed consent exclusion criteria: * women who refused a transvaginal scan * pregnant women * surgical removal is delayed for more than 120 days from the date of the ultrasound examination * previous history of ovarian, peritoneal or fallopian tube cancer or unknown malignancy * history of bilateral oophorectomy

Keywords: biomarker he4 ca-125 iota roma rmi pelvic mass ovarian cancer
study of ntx®-265: human chorionic gonadotropin (hcg) and epoetin alfa (epo) in acute ischemic stroke patients

Conditions: Stroke

Summary: the purpose of this study is: * to assess the neurological outcome in acute ischemic stroke patients treated with ntx®-265, when compared with patients given a placebo control. * to assess the safety and tolerability of ntx®-265 when given to acute ischemic stroke patients.


Eligibility criteria:
inclusion criteria: * age 18-85 * nihss score 8-20 * stroke is ischemic in origin, supratentorial, and radiologically confirmed * patient is 24-48 hours from time of stroke onset when the first dose of ntx®-265 therapy is administered * reasonable expectation of availability to receive the full 9 day ntx®- 265 therapy and subsequent follow-up visits * reasonable expectation that patient will receive standard post-stroke physical, occupational, speech, and cognitive therapy as indicated * female patient is either not of childbearing potential or agrees to use two of the effective separate non-hormonal forms of contraception throughout the study exclusion criteria: * patients presenting with lacunar, hemorrhagic and/or brain stem stroke * patients who have received tissue plasminogen activator (tpa)following the index stroke * patients classified as comatose * women who have tested positive for pregnancy, or are breast-feeding, or are not using a birth control * serum hemoglobin \> 16 grams(g)/deciliter (dl)(males) or \> 14 g/dl (females); or platelet count \> 400,000/cubic millimeters(mm3) * advanced liver, kidney, cardiac, or pulmonary disease * elevated serum bilirubin,alkaline phosphatase, aspartate aminotransferase (ast) or alanine transaminase (alt),creatinine, or prostate-specific antigen (psa) levels * patients with a known history of hypercoagulability * expected survival \< 1 year * allergy or other contraindication to hcg or epo * a known diagnosis of cancer in the previous 5 years * uncontrolled hypertension * use of either hcg or epoetin alfa within the previous 90 days * any condition known to elevate hcg * patients with a pre-stroke/pre-morbid modified rankin score (mrs)≥ 2 * any patients not living independently * any other medical condition or degree of stroke such that, in the investigator's opinion, the patient should not be included in the trial * with the exception of the qualifying stroke, any other stroke within the previous 3 months * patients who cannot take anti-platelet or anti-coagulant therapy * pre-existing and active major psychiatric or other chronic neurological disease * alcohol abuse or have a history of substance abuse or dependency within 12 months prior to the study * currently participating in another investigational study
postoperative pain after root canal preparation using different engine-driven systems

Conditions: Asymptomatic Molar Teeth With Periapical Lesions

Summary: a hundred twenty patients who had an asymptomatic mandibular molar teeth with periapical lesion were included. for each patient, teeth were prepared with reciproc blue or protaper universal instruments. each tooth was obturated with gutta-percha and resin-based sealer using single cone technique for mesial roots and for distal roots single cone and cold lateral compaction technique. root canal treatment was performed in a single visit. postoperative pain was assessed as no, mild, moderate, or severe at 6, 12, 24, 48, 72 hours and 7 days after obturation.

the aim of this study was to compare the effect of root canal preparation techniques on the occurrence and intensity of postoperative pain in patients with asymptomatic mandibular molar teeth with periapical lesions.a hundred twenty patients who had an asymptomatic mandibular molar teeth with periapical lesion were included. for each patient, teeth were prepared with reciproc blue or protaper universal instruments. each tooth was obturated with gutta-percha and resin-based sealer using single cone technique for mesial roots and for distal roots single cone and cold lateral compaction technique. root canal treatment was performed in a single visit. postoperative pain was assessed as no, mild, moderate, or severe at 6, 12, 24, 48, 72 hours and 7 days after obturation.for the comparison of pain scores between the tested instrumentation systems, the mann whitney test was used. differences between postoperative pain intencity for each instrumentation technique, at different time intervals, were assessed by the friedman test. for the association of pain and an analgesic intake with gender, the chi-square test was performed. for the association of pain with age and an analgesic intake were calculated using mann whitney test. a p value \< .05 or less was considered significant.

Eligibility criteria:
inclusion criteria: * patients without systemic diseases * patients who had a mandibular first molar with asymptomatic periapical lesion without previous endodontic treatment with no sensitivity to percussion * patients who had no spontaneous pre-treatment pain * patients not having taken any analgesics, antibiotics or corticosteroids before the treatment visit, * patients who had no allergic reaction to naocl and no intolerance to nonsteroidal anti-inflammatory drugs. exclusion criteria: * patients who had severe periodontal disease * the teeth with previous endodontic treatment * the teeth with root canal calcification, root resorption * the teeth that could not be isolated with rubber dam or were not suitable for further restoration

Keywords: one-visit root canal treatment, engine-driven instruments, asymptomatic molar teeth wtih periapical lesions