Kornimate/medical-research-clean huggingface dataset:
contrast-enhanced ultrasound imaging in diagnosing liver cancer in patients with cirrhosis

Conditions: Liver Cirrhosis

Summary: this clinical trial studies how well contrast-enhanced ultrasound imaging works in diagnosing liver cancer in patients with cirrhosis. diagnostic procedures, such as contrast-enhanced ultrasound imaging, may help find and diagnose liver cancer.

primary objectives: i. to evaluate the sensitivity, specificity, positive and negative predictive values of contrast-enhanced ultrasound (ceus) for diagnosis of hepatocellular carcinoma (hcc) in patients at risk for hcc in a multicenter setting. secondary objectives: i. to validate ceus liver imaging reporting and data system (li-rads) and determine the prevalence of hcc in each ceus li-rads category. ii. to evaluate inter-reader reliability of ceus for hcc diagnosis. iii. to evaluate covariates that might limit diagnostic performance of ceus for hcc diagnosis.

Eligibility criteria:
inclusion criteria: * capable of making informed decisions regarding his/her treatment * have known cirrhosis or other risk factors for hcc, based on american association for the study of liver diseases (aasld) and european association for the study of the liver (easl) guidelines (applicable in each site jurisdictions) * patients with untreated focal liver observations on liver ultrasound or multiphase contrast-enhanced ct or mri performed as part of clinical standard of care within 4 weeks before patient enrollment. or • patients with untreated focal liver observations scheduled for follow-up multiphase contrast-enhanced ct or mri, biopsy or surgical excision as part of clinical standard of care. ceus should be performed within 4 weeks before or after follow-up imaging or within 4 weeks before biopsy or surgical excision. exclusion criteria: * patients who are pregnant or lactating * patients with focal liver observations less than 5 mm or greater than 5 cm in size * patients with contraindications to ceus * patients with contraindications to both ct and mri * patients who are medically unstable, terminally ill, or whose clinical course is unpredictable * liver nodule previously treated with trans-arterial or thermal ablation * patients who have received an investigational drug in the 30 days before ceus, or will receive one within 72 hour after their ceus exam
kronos early estrogen prevention study (keeps)

Conditions: Menopause; Arteriosclerosis

Summary: the study will examine the effects of estrogen and progesterone on the development of atherosclerosis in menopausal women when hormone treatment is initiated within 3 years of the menopausal transition.

the keeps is designed to explore the hypothesis that early initiation of hormone therapy, in women who are at the inception of their menopause, will decrease the rate of accumulation of atherosclerotic plaque, indicating a likely delay in the onset of clinical cardiovascular disease. the study is designed as a multicenter, 4 year randomized clinical trial. it will evaluate the effectiveness of of 0.45 mg/day of oral conjugated equine estrogens or 50 mcg/day of transdermal estradiol via skin patch changed weekly (each in combination with cyclic oral, micronized progesterone, 200 mg daily for 12 days per month), versus placebo in preventing progression of carotid intimal medial thickness by sonogram and the accrual of coronary calcium in women aged 42-58 who are within 36 months of their final menstrual period at initiation of treatment. a number of secondary endpoints including biochemical and genetic risk factors for cardiovascular and thrombotic disease, and effects on cognition will also be studied. the study will enroll a total of 720 women in 2005-6, with an anticipated completion of the trial in 2010.

Eligibility criteria:
inclusion criteria: * menses absent for at least 6 months and no more than 36 months * good general health * plasma fsh level greater than or equal to 35 miu/ml * estradiol levels \< 40 pg/ml * normal mammogram within 1 year of randomization exclusion criteria: * use of hormone replacement or supplement within 3 months of randomization * endometrial thickness \>5 mm by vaginal ultrasound * in utero exposure to diethylstilbestrol (des) * current smoking \> 10 cigarettes/day * obesity-body mass index \> 35 * history of clinical cardiovascular disease * history of cerebrovascular disease * history of thromboembolic disease * coronary calcium score ≥ 50 units * dyslipidemia-ldl cholesterol \>190 mg/dl * hypertriglyceridemia-triglycerides \>400 mg/dl * lipid lowering medication (statin, fibrate,or \> 500 mg/day of niacin) * nut allergy (prometrium includes peanut oil) * uncontrolled hypertension-systolic bp \>150 and/or diastolic bp \> 95 * hysterectomy * history of, or prevalent, chronic diseases including any cancer (other than basal cell skin cancers), renal failure, cirrhosis, diabetes mellitus, and endocrinopathies other than adequately treated thyroid disease * known hiv infection and/or medications for hiv infection * results of any safety laboratory test chemistries, (tsh, cbc, u/a) more than 20% abnormal

Keywords: perimenopause coronary disease estrogen replacement therapy hormone replacement therapy
bilateral elective neck dissection in salvage total laryngectomy

Conditions: Neck Cancer; Larynx; Larynx Cancer; Neck

Summary: the aim of this study is to evaluate the role of elective bilateral neck dissection in patients with clinically negative lymph nodes (cn0) who underwent salvage total laryngectomy, by estimating the prevalence of histologically positive occult lymph nodes (pn+). secondary objective will be the assessment of complication rate and the evaluation of 5-year overall survival (os) and 5-year disease-specific survival (dss) in these patients.


Eligibility criteria:
inclusion criteria -patients affected by recurrent laryngeal cancer after primary treatment failure (surgery or radiotherapy or chemoradiotherapy), with no clinical or radiological evidence of lymph node metastasis in the neck (cn0),who underwent salvage total laryngectomy and concomitant bilateral elective neck dissection (levels ii, iii, iv and vi). exclusion criteria: * patients who received other salvage laryngeal resection such as open partial horizontal laryngectomy, endoscopic partial laryngectomy, or who did not undergo bilateral selective neck dissection.

Keywords: neck dissection salvage total laryngectomy
lorazepam for the treatment of status epilepticus or repetitive status epilepticus in japan

Conditions: Status Epilepticus

Summary: the purpose of this study is to determine the efficacy, safety and pharmacokinetics of lorazepam on japanese patients with status epilepticus or repetitive status eplilepticus.


Eligibility criteria:
inclusion criteria: * subjects with status epilepticus or repetitive status epilepticus / cluster seizure who have seizures that can be evaluated by investigator's visual observations based on motor symptoms or who have seizures that can be evaluated by eeg. * subjects with status epilepticus accompanied by generalized seizure, partial seizure or secondarily generalized seizure lasting 5 minutes or longer * subjects with repetitive status epilepticus / cluster seizure accompanied by not less than 3 consecutive episodes of generalized seizure, partial seizure or secondarily generalized seizure in 1 hour. * subjects not younger than 3 months (either gender is eligible for the study) exclusion criteria: * subjects with known or suspected recurrent seizures due to illegal drug or alcohol withdrawal * subjects with known history of hypersensitivity to lorazepam or benzodiazepine * subjects with a known history of benzodiazepine abuse. * subjects currently receiving lorazepam * subjects with angle-closure glaucoma * subjects with myasthenia gravis * subjects with either of aspartate transaminase, alanine transaminase, total bilirubin, blood urea nitrogen, or creatinine at screening visit exceeding 2x the upper limit of normal of the institutional reference value (if the data is available) * subjects with white blood cell count less than 3000/mm3 or neutrophil count less than 1500/mm3 at screening visit (if the data is available)

Keywords: lorazepam status epilepticus
a study of treatment patterns and outcomes in participants with human epidermal growth factor receptor 2 (her2)-positive unresectable locally advanced or metastatic breast cancer

Conditions: Metastatic Breast Cancer; Locally Advanced Breast Cancer

Summary: this disease registry is a prospective, multicenter non-interventional study designed to observe anti-cancer treatment regimens and clinical outcomes in participants with her2-positive unresectable locally advanced breast cancer (labc) or metastatic breast cancer (mbc).


Eligibility criteria:
inclusion criteria: * diagnosis of her2-positive unresectable labc or mbc within 6 months prior to enrollment exclusion criteria: * none specified
treatment of postoperative pain after total hip arthroplasty using intravenous lidocaine infusion

Conditions: Postoperative Pain Management After Total Hip Arthroplasty

Summary: this study will focus on patients undergoing total hip arthroplasty and loma linda university medical center \& east campus. these patients will be randomized to receive a low dose lidocaine infusion or placebo, in addition to the patient controlled analgesia pump. these groups will be compared to one another statistically to determine which group shows the safest and most satisfying pain control.


Eligibility criteria:
inclusion criteria: * adult male or female undergoing a total hip arthroplasty subject is american society of anesthesiologists physical status 1, 2, or 3 subject has voluntarily signed and dated the informed consent document approved by the irb be english speaking exclusion criteria: * age \> 80 years old or younger than 18 years old congestive heart failure hepatic insufficiency neurological disorders psychiatric disorders steroid treatment no history of atrial fibrillation chronic pain disorder with opioid treatment

Keywords: postoperative pain management
quantitative us for evaluation of hepatic steatosis in nafld

Conditions: Fatty Liver; Fatty Liver, Nonalcoholic

Summary: the purpose of this study is to evaluate diagnostic performance of quantitative ultrasonographic parameters for the assessment of hepatic steatosis with find optimal cut-off values in patients with non-alcoholic fatty liver disease using magnetic resonance imaging proton density fat fraction (mri-pdff) and mr spectroscopy as the reference standard.


Eligibility criteria:
inclusion criteria: * patients with known nafld or suspected of having nafld * patients who are scheduled hepatectomy for living donor liver donation * aged ≥ 18 years who are willing and able to complete all procedures exclusion criteria: * excessive alcohol consumption within 2 years (40g/day for men, 20g/day for women) * clinical, laboratory, or histologic evidence of a liver disease other than nafld, including viral hepatitis, autoimmune hepatitis, or genetic or acquired disorders * use of steatogenic or hepatotoxic medication * evidence of decompensated liver disease * history of liver surgery * contraindication to mri * any other condition believed by investigator to affect a patients' compliance, or completion of the study
prevalence of musculoskeletal disorders of upper limb in type 1 diabetes patients

Conditions: Type 1 Diabetes

Summary: osteopenia and osteoporosis, particularly related to insulinopenia, are common in type 1 diabetes and increase the risk of fractures. musculoskeletal disorders of the upper limb are a common complication of type 1 diabetes. however, there is no official recommendation for screening for musculoskeletal disorders in france.

the aim of the study is to describe prevalence of musculoskeletal disorders of upper limb in type 1 diabetes patients.

Eligibility criteria:
inclusion criteria: * male or female * aged of 18 and more * with type 1 diabetes * agreeing to participate in the study exclusion criteria: * none

Keywords: musculoskeletal disorders prevalence
clinical and cpet parameters that predict improvement in functional capacity after tavi

Conditions: Aortic Stenosis Disease

Summary: determining clinical and cardiopulmonary exercise testing parameters that may predict improvement in capacity after transcatheter aortic valve implantation

transcatheter aortic valve implantation (tavi) has emerged as a less invasive alternative to surgical aortic valve replacement, especially for high-risk patients. however, existing research on functional outcomes after tavi has yielded mixed results. to our knowledge, the potential functional benefit of tavi has not been well explored using cardiopulmonary exercise testing (cpet). the present study aims to 1) characterize the mid-term exercise tolerance response to tavi, and 2) determine the clinical (symptoms, frailty, quality of life, etc.) and functional factors (parameters derived from cpet) that determine the magnitude of this response. a positive functional response to tavi will be considered as an increase in vo2 max \> 2.5ml/kg/min or \>10% of its baseline value one month post-tavi. the exercise test will be conducted by a physiotherapist and supervised by a physician using a standard incremental cardiopulmonary exercise testing on cycle ergometer (ergoline 900, ergoline, bitz, germany (ce-0123) and ergocard professional, medisoft, sorinnes, belgium (ce-1434)). to this end, 161 patients with severe aortic stenosis scheduled for tavi will be included in 3 expert centres. they will be evaluated clinically and functionally (incremental cpet) in the 2 weeks prior to the procedure and 4-6 weeks after.

Eligibility criteria:
inclusion criteria: * all those patients ≥ 18 years of age with severe aortic stenosis approved for transfemoral tavi. both sexes, male and female will be included in the study. exclusion criteria: very severe aortic stenosis, defined as a valve area of ≤0.6 cm2 , mean gradient ≥60 mmhg or vmax \>5 m/s * previous syncope * proven exercise-induced arrhythmias * previously known dynamic left ventricular outflow tract (lvot) obstruction, defined as lvot gradient of ≥ 30 mmhg by echocardiography * concomitant coronary artery disease pending percutaneous coronary intervention * inability to consent * physical limitation to perform an exercise test * non-elective procedure * valve-in-valve procedure
comparison of rt in patients with sleep apnea with and without complaints of daytime sleepiness

Conditions: Sleep Apnea

Summary: not all patients with the obstructive sleep apnea syndrome (osas), mostly mild, have excessive daytime sleepiness. sleep fragmentation provides the performance decrease with increasing reaction time to external stimuli and correlates with excessive sleepiness. so, the study aims at assessing the effect of sleep fragmentation on the reaction time and it's maintenance in patients with osas compared with healthy, to better clarify were patients with and without somnolence differ. for that, will be recruited 30 male volunteers aged between 20 and 50 year old to participate in the study. they will be distributed in three groups: "control" (without symptoms of sleepiness and apnea and hypopnea index (ahi) less than 5), "ss" (with ahi between 5 and 15 without symptoms of somnolence) and group "cs" (with ahi between 5 and 15 with symptoms of somnolence). the groups will undergo a polysomnography and subsequently, the test and maintenance of wakefulness and pvt battery tests. the reaction time will be compared, as well as the ability to keep the reaction time over time between groups to see whether there is a difference between the motor performance throughout the day and the perception of sleepiness.


Eligibility criteria:
inclusion criteria: * man * aged between 20 and 45 years old * bmi between 20-30 exclusion criteria: * cigarette smoke * drug intake * other sleep disturbances

Keywords: apnea pvt reaction time
sodium lactate infusion in glut1ds patients

Conditions: GLUT1 Deficiency Syndrome; GLUT1DS1; GLUT1DS2; Epilepsy; Lactic Acid Blood Increased; Ketogenic Dieting

Summary: this study investigates the effect of lactate infusion on epileptic discharges on eeg and seizure frequency in glucose transporter 1 deficiency syndrome (glut1ds) patients.

in glucose transporter 1 deficiency syndrome (glut1ds) cerebral glucose uptake from the systemic blood circulation is limited, because of deficient transport of glucose across the blood-brain barrier by the transporter protein (glut1). classically patients present with developmental problems, movement disorders and severe epilepsy. there is no curative treatment for glut1ds, and anti-epileptic drugs usually have little to no effect. the ketogenic diet, providing ketones as an alternative energy substrate for the brain is an effective treatment option for the epilepsy and movement disorders in many glut1ds patients. unfortunately, not in all glut1ds patients the ketogenic diet has a positive effect and other treatment options for these patients are very limited. traditionally, lactate is seen as a waste product of glycolysis during anaerobic conditions and a marker of ischemia. interestingly, research has shown the beneficial side of lactate as an energy source for different organs. it seems that the brain can indeed use lactate as an alternative energy metabolite, besides glucose and ketones. the aim of this study is to investigate whether lactate can be an alternative energy metabolite in the glut1ds brain, and reduce epileptic discharges on eeg when intravenously administered in patients with glut1ds.

Eligibility criteria:
inclusion criteria: * diagnosed with glut1ds and known in our center. * baseline characteristics include a high frequency of clinical seizures and epileptic discharges on eeg. * history of trying ketogenic diet with good compliance without beneficial effects. * age \> 6 years. * informed consent. exclusion criteria: * additional medical condition or illness that impairs the patient's ability to participate in the study (for example actual treatment of a malignancy, active infection, poorly controlled diabetes mellitus, hypertension, organ failure, clinically significant haematological or biochemical abnormalities). * elevated serum sodium (\> 145 mmol/l). * participation in another interventional study at start of the study or during the study. * presence of known panic disorders or a history of panic attacks.

Keywords: glut1 deficiency syndrome sodium lactate infusion epilepsy
shr-1210 alone or in combination with decitabine in relapsed or refractory hodgkin lymphoma

Conditions: Hodgkin Lymphoma

Summary: this is a two-stage, phase ii clinical trial for patients with relapsed or refractory hodgkin lymphoma. the purpose of stage i is to evaluate whether treatment with the study drug decitabine in combination with shr-1210 is safe and more effective than treatment with shr-1210 alone; and reverse the resistance of anti-pd-1 antibody in patients with hl who had previously treated with anti-pd-1 monotherapy. if it is deemed that the combination therapy is more efficacious than shr-1210 monotherapy (the cr rate of the combination group is at least 30% higher compared to monotherapy group with a minimal follow-up of 6 months in predicting 60 subjects naïve to anti-pd-1 antibody who are randomly assigned (2:1) to the above two groups), the stage ii study will be revised to a multicohort, decitabine-plus-shr1210 single-arm clinical trial. the primary objective of stage ii study is to evaluate the long-term response duration with decitabine-plus-shr-1210 in relapsed or refractory hodgkin lymphoma.


Eligibility criteria:
inclusion criteria: * 1 subjects must have histological confirmation of relapsed or refractory hodgkin lymphoma (hl). 2 12 to 75 years of age. 3 ecog performance of less than 2. 4 life expectancy of at least 3 months. 5 subjects with lymphoma must have at least one measureable lesion \>1 cm as defined by lymphoma response criteria. 6 subjects must have received at least four prior chemotherapy regimen, and must be off therapy for at least 4 weeks prior to day 1. subjects with autologous hematopoietic stem-cell transplantation are eligible which must be more than 3 months.subjects with anti-pd-1 antibody are eligible which must be resistance. 7 subjects must have adequate marrow, live, renal and heart functions. exclusion criteria: * 1 subjects with any autoimmune disease or history of syndrome that requires corticosteroids or immunosuppressive medications. 2 serious uncontrolled medical disorders or active infections, pulmonary infection especially. 3 active alimentary tract hemorrhage or history of alimentary tract hemorrhage in 1 month . 4 prior organ allograft. 5 women who are pregnant or breastfeeding. 6 women with a positive pregnancy test on enrollment or prior to investigational product administration. 7 subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness.

Keywords: relapsed/refractory; hodgkin lymphoma；decitabine; shr-1210
nutrition intervention to address anemia among adolescent girls in liberia

Conditions: Nutritional Anemia; Nutritional Deficiency; Iron Deficiency Anemia Treatment; Folic Acid Deficiency Anemia, Dietary; Adolescent Development; Knowledge, Attitudes, Practice; Food Habits

Summary: the purpose of this study is to evaluate the feasibility and effectiveness of weekly iron and folic acid (ifa) supplementation and one-time deworming treatment at the community level in improving hemoglobin levels among adolescent girls in liberia, west africa, and to assess the feasibility and effectiveness of a targeted nutrition education program in improving nutrition knowledge, attitudes, and practices in the same population.


Eligibility criteria:
inclusion criteria: * adolescent girl aged 10 - 19 years at the time of enrollment * lives within the selected study communities in montserrado or margibi counties * caregiver/adolescent consents to participate in the study exclusion criteria: * currently pregnant * active malaria infection as defined by positive rapid diagnostic test (rdt) * severe acute malnutrition at the time of enrollment * known malignancy * known sickle cell disease