Kornimate/medical-research-clean huggingface dataset:
succinylated gelatin for prevention of fluid retention in patients with breast cancer receiving docetaxel chemotherapy

Conditions: Fluid Retention

Summary: breast cancer patients who received docetaxel chemotherapy were randomly divided into two groups; experimental group: the patients received intravenous infusion of succinylated gelatin one day before and on the day of chemotherapy, 500ml each time, once per day; control group: observation. primary endpoint: total incidence of fluid retention. secondary endpoints: severity and duration of fluid retention, change in quality of life score.


Eligibility criteria:
inclusion criteria: * signed informed consent * age ≥18 years * diagnosed with breast cancer * ecog 0-2 * received chemotherapy with docetaxel exclusion criteria: * existed peripheral edema, ascites and pleural or pericardial effusion * serum creatinine exceeds 1.5 times of the upper normal limit * total serum bilirubin exceeds 1.25 times of the upper normal limit, or asat exceeds 2 times of the upper normal limit

Keywords: fluid retention chemotherapy succinylated gelatin breast cancer
phase iii randomized study of poloxamer 188 for vaso-occlusive crisis of sickle cell disease

Conditions: Sickle Cell Anemia

Summary: objectives: i. assess the efficacy of poloxamer 188 in reducing the duration of painful vaso-occlusive crisis in patients with sickle cell disease. ii. assess the effect of poloxamer 188 on duration and intensity of pain, total analgesic use, and length of hospitalization of these patients.

protocol outline: this is a randomized, double blind, placebo controlled, multicenter study. patients are stratified according to hydroxyurea use. patients are randomized to treatment poloxamer 188 or placebo. treatment begins within 12 hours of presentation with crisis. patients receive poloxamer 188 or placebo by continuous infusion for 48 hours. pain is assessed before, during, and after treatment. patients are followed on days 7-14 and 28-35.

Eligibility criteria:
protocol entry criteria: --disease characteristics-- * sickle cell disease confirmed by electrophoresis or high pressure liquid chromatography * at least one prior documented painful crisis episode but no greater than 10 crises per year for the last two years * sudden onset of acute pain lasting 4-12 hours and involving at least one site * severe crisis pain that requires parenteral analgesics and hospitalization, but not within the preceding 2 weeks --prior/concurrent therapy-- * surgery: at least 2 weeks since prior major surgery no concurrent surgery * other: at least 2 weeks since prior puncture of noncompressible vessels no prior therapy using poloxamer 188 no concurrent investigational drug no concurrent use of nonsteroidal anti-inflammatory drugs --patient characteristics-- * hematopoietic: no significant bleeding or bleeding disorder * hepatic: alt no greater than 2 times normal * renal: no active renal disease creatinine no greater than 1.0 mg/dl or creatinine clearance greater than 50 ml/min protein less than 300 mg/dl * cardiovascular: no evidence of acute myocardial ischemia or infarction * neurologic: at least 6 months since prior cerebrovascular accident or seizure * other: not pregnant fertile patients must use effective contraception during and for at least 30 days after treatment no history of chronic bacterial osteomyelitis no history of drug or alcohol abuse at least 6 months since prior use of illicit drug have adequate iv access no crisis with life-threatening complications such as: hepatic or splenic sequestration acute chest syndrome aplastic crisis no known infection or infection with encapsulated organism no evidence of septic shock not concurrently hospitalized for other conditions not concurrently on hypertransfusion program

Keywords: disease-related problem/condition genetic diseases and dysmorphic syndromes hematologic disorders pain rare disease sickle cell anemia
cetuximab, paclitaxel, carboplatin & radiation for esoph, gastroesoph & gastric cancer

Conditions: Esophageal Cancer; Gastric Cancer

Summary: cetuximab, paclitaxel, carboplatin and radiation for esophageal, gastroesophageal junction and gastric cancer

the primary objective of this phase ii trial is to estimate the rate of complete pathologic response as determined by surgical resection or post treatment endoscopy (for patients not undergoing resection) for the treatment regimen being tested. with a total accrual of 28 evaluable patients.

Eligibility criteria:
inclusion criteria: * patients are required to have pathologically confirmed adenocarcinoma or squamous cell carcinoma of the esophagus, gastroesophageal junction, or stomach. * patients may have mediastinal, celiac adenopathy, peri-portal and regional gastric lymphadenopathy. * there must be no evidence of distant organ metastases. * no prior radiation for gastric or esophageal cancer. * patients must be \> 18 years of age, and nonpregnant * patients must have an anc \> 1,500/ul, platelets \> 100,000/ul, creatinine \< 2 x upper limit normal (uln) and bilirubin \< 1.5 x uln, and ast \< 3 x uln. * ecog performance status 0-2. * patients must not have significant infection or other coexistent medical condition that would preclude protocol therapy. * female patients, must either be not of child bearing potential or have a negative pregnancy test within 7 days of starting study treatment. patients are considered not of child bearing potential if they are surgically sterile (they have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are postmenopausal. pregnant or lactating females are not eligible. * all patients must sign informed consent exclusion criteria: any of the following criteria will make the patient ineligible to participate in this study: * acute hepatitis or aids. * active or uncontrolled infection. * significant history of uncontrolled cardiac disease; i.e., uncontrolled hypertension, unstable angina, recent myocardial infarction (within prior 6 months), uncontrolled congestive heart failure, and cardiomyopathy with decreased ejection fraction. * prior therapy which specifically and directly targets the egfr pathway. * prior severe infusion reaction to a monoclonal antibody. * any concurrent chemotherapy not indicated in the study protocol or any other investigational agent(s).

Keywords: esophageal cancer gastroesophageal cancer gastric cancer
study of the vascular disrupting agent npi-2358 in patients with advanced solid tumors or lymphoma

Conditions: Cancer

Summary: this is a phase 1 clinical trial examining the safety, pharmacokinetics and pharmacodynamics of escalating doses of the vascular disrupting agent npi-2358 in patients with refractory solid tumors or lymphoma. the formation of new blood vessels (angiogenesis) is an important component of tumor growth and vascular disrupting agents are intended to target the differences between these tumor blood vessels and the blood vessels in normal tissues. npi-2358 has also been seen to directly affect tumor cells.


Eligibility criteria:
inclusion criteria: * ecog performance status ≤ 2 * pathologically or histologically confirmed solid tumor malignancy * patients must not be candidates for regimens known to provide clinical benefit. * all adverse events of any prior chemotherapy, surgery, or radiotherapy, must have resolved to national cancer institute common terminology criteria for adverse events (nci ctcae) (v. 3.0) grade ≤ 2, except for neurological toxicity that must have resolved to grade ≤ 1. * adequate bone marrow reserve, hepatic and renal function * signed informed consent exclusion criteria: * administration of chemotherapy, biological, immunotherapy or investigational agent (therapeutic or diagnostic) within 21 days prior to receipt of study medication (6 weeks for nitrosoureas or mitomycin c; 12 weeks for radioimmunotherapy). major surgery, other than diagnostic surgery, within 6 weeks before first study drug administration. radiotherapy within 4 weeks (some types of radiation therapy are excluded regardless of interval since treatment). * significant cardiac history or findings * underlying conditions or medications associated with bleeding diathesis * disorders associated with significant vascular pathology * lung cancer with central chest tumors * prior treatment with vascular disruptive agents * seizure disorder requiring anticonvulsant therapy; prior transient ischemic attack or cerebrovascular accident * brain metastases * severe chronic obstructive pulmonary disease (copd) with hypoxemia * active uncontrolled bacterial, viral, or fungal infection, requiring systemic therapy * known infection with human immunodeficiency virus (hiv), active hepatitis a, b, or c * patients with a prior hypersensitivity reaction to any product containing solutol and/or propylene glycol * pregnant or breast-feeding women. female patients must be postmenopausal, surgically sterile or they must agree to use acceptable methods of birth control. female patients with childbearing potential must have a negative serum pregnancy test. male patients must be surgically sterile or agree to use an acceptable method of contraception. * concurrent, active second malignancy for which the patient is receiving therapy, excluding basal cell carcinoma of the skin or carcinoma in situ of the cervix

Keywords: solid tumors lymphomas
decade-long insights into transperineal prostate biopsy in a west china population

Conditions: Prostate Cancer; Pathology

Summary: prostate cancer (pca) remains one of the most prevalent malignancies affecting men globally. the disease spectrum of pca ranges from indolent tumors, which may require minimal to no intervention, to aggressive, potentially lethal forms. the complexity of pca underscores the critical need for precise diagnostics, as early and accurate detection is key to improving patient outcomes and tailoring appropriate treatment strategies. there have been remarkable advancements in biopsy technology. significant strides in magnetic resonance imaging (mri), especially with the establishment of the prostate imaging reporting and data system (pi-rads), have substantially improved the accuracy of pca detection. the combination of mri with traditional biopsy methods, including mri-targeted biopsy (mri-tbx) and systematic biopsy (sbx), also marks a major advancement in the field. despite advances in pca detection, the need for improving diagnostics and in-depth assessment of the latest pbx techniques through extensive, longitudinal studies remains critical. besides, based on the world health organization (who) classification, pca includes a range of pathological forms beyond the commonly known acinar adenocarcinoma. however, the prevalence and demographic distribution of non-adenocarcinoma types, as well as the characteristics of patients with these rarer forms, remain unclear. leveraging pbx records spanning over 10 years and involving 10,038 cases, this study aims to shed light on temporal trends in pbx positivity, the evolving clinical profiles of pca patients, and the differences in clinicopathological characteristics of pca between western and asian populations.


Eligibility criteria:
inclusion criteria: * patients suspected of pca who underwent transperineal pbx at our medical center, from 2011 to 2022 exclusion criteria: * patients with other cancers
pilot study on the use of acupuncture for postpartum depression

Conditions: Post-partum Depression

Summary: the proposed study is a randomized controlled trial to examine the efficacy and safety of active acupuncture versus placebo acupuncture for the treatment of postpartum depression. the investigators hypothesis is that active acupuncture would be superior to placebo acupuncture in the short-term treatment of postpartum depression.

this study will be a randomized, controlled, subject- and assessor-blind trial in patients with postpartum depression. eligible subjects will be randomly assigned to active acupuncture or placebo acupuncture. the subjects will receive acupuncture treatment twice per week for 4 consecutive weeks. the acupuncturist of this trial will not participate in data collection and data entry. the trial assessor will be blind to the subjects' treatment allocation.

Eligibility criteria:
inclusion criteria: * ethnic hong kong chinese aged 18 years or above; * within 6 months of giving birth; * edinburgh postnatal depression scale (epds) (cox et al., 1987) score higher than or equal to 12 or being diagnosed as depressed by their obstetrician; * meeting the diagnostic and statistical manual of mental disorders-iv diagnosis criteria for major depressive disorder; * 17-item hamilton depression rating scale (hdrs17) (hamilton, 1960) score of between 12 and 19 at screening and baseline assessment; * willingness to give informed consent and comply with trial protocol. exclusion criteria: * suffering from other psychiatric disorders such as schizophrenia, other psychotic disorders, bipolar disorder or substance use disorder; * serious physical illnesses or mental disorders due to a general medical condition which are judged by the investigator to render unsafe; * a significant risk of suicide according to the rating of hdrs17 item 3 (score higher than 2), i.e., presence of ideas or gesture of suicide; * a presence of idea of self-harming according to the rating of epds item 10 (score higher than 0); * a significant risk of infanticide according to the investigator assessment; * any acupuncture treatment during the previous 12 months prior to baseline; * valvular heart defects, bleeding disorders or taking anticoagulant drugs; * infection or abscess close to the site of selected acupoints; * herbal remedies or psychotropic drugs that are intended for depression are taken within the last 2 weeks prior to baseline or during the study. * receiving counseling or psychological therapies at baseline or during the study; * participation in any clinical trial within the previous 3 months prior to baseline;

Keywords: insomnia post-partum depression electroacupuncture acupuncture randomized clinical trial traditional chinese medicine
predictive value of mean flow velocity by tcd in early cerebral vasospasm in aneurysmal subarachnoid hemorrhage

Conditions: Subarachnoid Hemorrhage

Summary: aim of this work is to evaluate the transcranial doppler in prediction of cerebral vasospasm in aneurysmal subarachnoid hemorrhage and also to evaluate their advantages over clinical scales in predicting cv.

cerebral vasospasm is defined as narrowing of a cerebral blood vessel enough to cause reduction in distal blood flow. seventy percent of asah patients develop angiographic vasospasm but only 30% progress to develop evident neurological deficits. cerebral vasospasm may be asymptomatic with no clinical symptoms and signs but only abnormal investigations, such as vascular stenosis by angiography or high blood flow speed by doppler ultrasound. standard tests used to determine the source of bleeding and diagnose cerebral vasospasm (cv) include neuroimaging studies that administer contrast either intravenously (computed tomography angiography \[cta\]) or intra-arterially (digital subtraction angiography \[dsa\]). cerebral blood flow measurements using computed tomography (ct) perfusion techniques may detect the degree of cerebral ischemia in a very early stage. although well-tolerated, these studies cannot be readily performed on the bedside and expose the patient to additional radiation, thus significantly restricting their use in daily cerebral hemodynamics monitoring. moreover, they involve patient transportation to the ct scanner and utilization of resources such as nurses, technologists, and ancillary personnel. early detection of cerebral vasospasm is an important step in the way of the improvement of the outcome and the survival of asah patients. transcranial duplex (tcd) is a non-invasive modality which can assess the cerebral blood vessels diameters and flow velocities that can be a useful maneuver in early detection of vasospasm after asah

Eligibility criteria:
inclusion criteria: * adult patients diagnosed with spontaneous aneurysmal sah diagnosed by non-contrast brain ct scan at the onset and confirmed by ct angiography within 72 hours of onset were included exclusion criteria: * patient with previous history of disabling brain injuries causing focal neurological signs (e.g. motor weakness). * patients with poor temporal tcd window required for bedside evaluation of cv. * patients with decompensated systemic illness like hepatic, renal and cardiac were excluded. * patients with deep coma (gcs\<6) were excluded.
bendamustine and rituximab with or without orelabrutinib in mcl treatment

Conditions: Mantle Cell Lymphoma (MCL)

Summary: this multicenter, open-label, randomized controlled trial aims to evaluate the efficacy and safety of orelabrutinib in combination with bendamustine and rituximab (obr) versus bendamustine and rituximab (br) in patients with intermediate- to high-risk mantle cell lymphoma (mcl) who are ineligible for transplantation. the primary objective is to assess the complete response (cr) rate during the induction phase, with secondary objectives including progression-free survival (pfs), overall survival (os), objective response rate (orr), and safety. exploratory analysis will investigate the correlation between tumor biomarkers and treatment efficacy.


Eligibility criteria:
inclusion criteria: * diagnosed with mcl (mantle cell lymphoma) through flow cytometry or histopathology, and has not received prior treatment. * age \> 18 years of age, both genders are eligible. * ann arbor stage ii-iv; for stage ii subjects, those who require systemic therapy based on the investigator's judgment are eligible. * at least one measurable lesion. * eastern cooperative oncology group (ecog) performance status score of 0-2. * any one of the following high-risk factors is present: mipi score of 4-11, ki67 \> 50%, tp53 abnormality, blastic or pleomorphic variation. * patients who are not suitable candidates for autologous hematopoietic stem cell transplantation. * laboratory tests (blood routine, liver and kidney function) meet the following requirements: a) blood routine: white blood cell count ≥3.0×10\^9/l, absolute neutrophil count ≥1.5×10\^9/l, hemoglobin ≥90g/l, platelet count ≥75×10\^9/l. b) liver function: transaminases ≤2.5 times the upper limit of normal, bilirubin ≤1.5 times the upper limit of normal. c) serum creatinine 44-133 mmol/l. * the investigator judges that the subject's life expectancy is greater than 12 weeks from the time of screening. * willing and able to participate in all required assessments and procedures of the study protocol. exclusion criteria: * patients who have previously received treatment with btk inhibitors. * patients with severe complications or serious infections. * patients with uncontrolled cardiovascular diseases, coagulation disorders, connective tissue diseases, serious infectious diseases, etc. * patients with active infections requiring systemic treatment, including bacterial, fungal, and viral infections. * hiv-infected individuals. * patients with mental disorders or those who are known or suspected to be unable to fully comply with the study protocol. * patients whom the investigator judges to have other conditions that make them unsuitable for participation in this study.
role of nfkbia and ptpn22 genes polymorphism in acute rejection susceptibility after living donor liver transplantation in egyptian patients.

Conditions: Liver Transplant Rejection

Summary: our study aimed at studying the impact of gene polymorphism of nfkbia and ptpn22 genes on rejection episodes in liver transplant egyptian recipients. also assess patients' factors associated with graft rejection.

liver transplantation is considered an effective therapy for severe liver disease, but graft dysfunction occurs in up to 13% of patients during the first year following transplantation, and rises to 35% after 5 years (keeffe, 1999; yu et al., 2001). graft rejection is one of the major immunological complications following liver transplantation (zheng et al., 2006). the nuclear factor of kappa light polypeptide gene enhancer b-cells inhibitor-alpha (nfkbia) gene encodes a member of the nuclear factor-kappa-b inhibitor family. polymorphisms in this gene might be associated with a susceptibility to acute rejection episodes following liver transplantation, as they may cause an increased activation level of the proinflammatory transcription factor nuclear factor of kappa light polypeptide gene enhancer in b-cells (nfκb). nfκb translocates to the nucleus and promotes the expression of a panel of genes (karin and ben-neriah, 2000). some of these, for example interleukin-2, interleukin-6, interleukin-12 or tumor necrosis factor-alpha, play an important role in the pathogenesis of allograft rejection and the activation of the immune system in general (wei and zheng, 2003). the protein tyrosine phosphatase nonreceptor 22 gene (ptpn22) encodes a strong t-cell regulator called lymphoid protein tyrosine phosphatase. previously, ptpn22 was described as a susceptibility gene for autoimmunity because it contains single nucleotide polymorphisms (snps) associated with several autoimmune diseases. one snp (rs2476601;1858g\>a) has emerged as a particularly potent risk factor for autoimmunity. we address the question whether ptpn22 polymorphismsare also associated with acute rejection after liver transplantation. (dullin et al., 2015).

Eligibility criteria:
inclusion criteria: * adult patients with esld were subjected to living donor liver transplantation due to different etiologies including hepatitis c virus (hcv), hepatitis b virus (hbv), autoimmune hepatitis (aih), portal venous thrombosis (pvt), cryptogenic hepatitis, primary sclerosing cholangitis(psc), hepatocellular and carcinoma(hcc) were eligible for the study. recipients received calcineurin inhibitors either tacrolimus or cyclosporine as primary immunosuppressant ± mmf or evorilumus ± mmf immediately after transplantation. exclusion criteria: * patients were excluded if they had multi-organ transplantation, had previously received a liver transplant, or were receiving an abo-incompatible transplant.

Keywords: gene polymorphism