Kornimate/medical-research-clean huggingface dataset:
evaluation of panel reactive antibody in children following stage i palliation for hypoplastic left heart syndrome

Conditions: Congenital Heart Disease

Summary: the purpose of this study is to determine whether children and adolescents 8-18 years of age with hlhs and related lesions who have undergone stage i palliation during infancy using an allograft patch demonstrate continued evidence of hla antibody formation.

this study will be of a prospective cross-sectional design, consisting of three groups. the first two groups (study groups) will consist of (1) subjects with hlhs and other related lesions who have undergone stage i palliation using an allograft patch during infancy and (2) subjects with "single ventricle" lesions who have undergone stage ii palliation using allograft without antecedent stage i palliation. the third group (control group) will consist of subjects who have undergone corrective or palliative surgery for chd during infancy in which an allograft patch was not used, and in which there have been no further exposures to allograft. we have chosen to study both (1) subjects who have undergone stage i and ii palliation and (2)subjects who have undergone stage ii palliation only in an attempt to distinguish between sensitization that may occur from allograft exposure during stage i palliation and that which may occur during stage ii palliation.

Eligibility criteria:
inclusion criteria: * children and adolescents between 8 and 18 years of age. * parents/guardian permission (informed consent) * assent of the study subject * subjects followed within the chop cardiology division * operative note(s) available for review in medical record * have undergone stage i, stage ii palliation, or corrective surgery for congenital heart disease during infancy (\<1 year of age) not requiring allograft material. exclusion criteria: * refusal or withdrawal of informed consent and/or assent. * unavailability of medical records to confirm operative details. * additional surgeries (e.g., other than stage i or ii palliation) utilizing allograft * exposure to allograft at any point in control group age \ 18 years * presence of genetic syndrome known to affect immunologic function (e.g., digeorge syndrome)
long term clinical implications in chinese patients with aortic intramural hematoma

Conditions: Aortic Intramural Hematoma

Summary: the study evaluates outcomes of intramural hematomas after long-term follow up and establish predictive factors in chinese population.

270 intramural hematoma patients with clinical and imaging follow up were retrospectively studied in present study. the primary endpoint was consisted of aortic disease-related death, aortic dissection, penetrating atherosclerotic aortic ulcer , thickening of aorta hematoma and aortic complications requiring surgical or endovascular treatment.

Eligibility criteria:
inclusion criteria: * type a aortic hematoma * type b aortic hematoma exclusion criteria: * aortic without initial intimal flap formation.

Keywords: aortic intramural hematoma chinese patients clinical outcomes
preventive effects of bosentan on the systemic cardiovascular consequence of sleep apnea

Conditions: Obstructive Sleep Apnea; Hypertension

Summary: the study will compared the effects of bosentan, an endothelin receptor antagonist, and nasal continuous positive airway pressure (ncpap), obstructive sleep apnea current reference treatment, on diastolic blood pressure in untreated mildly hypertensive sleep apnea patients. the hypothesis is that blocking endothelin receptors with a drug will have the same systemic blood pressure lowering effect than ncpap in sleep apnea patients.


Eligibility criteria:
inclusion criteria: * documented obstructive sleep apnea * with untreated mild systemic hypertension exclusion criteria: * pregnancy or lactation * daytime alveolar hypoventilation * severe arterial hypertension (systolic pressure \> 180 mmhg; diastolic pressure \> 110 mmhg) * treatment with anti-hypertensive drugs * cardiovascular disorder other than mild hypertension * severe daytime sleepiness (score on the epworth sleepiness scale ≥15) or at-risk occupation * contra-indication to ncpap treatment * known allergy to bosentan * active treatment with a drug whose efficacy is reduced by cytochromes p450, 2c9, 3a4 and2c19 isoenzyme activation * active treatment with a drug acting on systemic arterial blood pressure or endothelial function * liver or kidney dysfunction

Keywords: cardiovascular system sleep endothelial function endothelin system
effects of phenytoin on cocaine use in humans - 2

Conditions: Cocaine-Related Disorders

Summary: the purpose of this study is to determine the effects of phenytoin on the self-administration of smoked cocaine.

the purpose of this study was to determine the effects of phenytoin on smoked cocaine-base self-administration using our laboratory self-administration model. a total of 12 patients randomized, 6 to phenytoin and 6 to placebo treatment group. there were 2 phases in this 10-day inpatient study. phase 1 subjects underwent one cocaine self-admin session. randomization took place at the start of phase 2, day 4 where subjects received either placebo or phenytoin. the subjects assigned to phenytoin treatment received an oral loading dose (20mg/kg) aimed at achieving plasma phenytoin concentration of (10-20 mg/l). during phase 2, subjects had the opportunity to self-administer cocaine on days 5, 7, and 9. the plasma phenytoin levels were expected to decrease gradually during phase 2 which provided an opportunity to study the effect of decreasing phenytoin plasma concentrations on cocaine self-administration.

Eligibility criteria:
inclusion criteria: males/females between the ages of 20-40. history of smoked cocaine use on the avg. of at least 2 times/week over a 6 month period. have currently used at least 1 g of cocaine within a 4-6 hr period. current history of good health, normal serum albumin levels and normal qtc intervals. nonreactive for hiv. no participation in any of our studies for the past 6 months. for females: not pregnant as determined by pregnancy screening nor breat feeding, and using acceptable birth control methods (e.g. birth control pills, diaphragm, condoms plus foam). exclusion criteria: history of suicide attempt, bipolar disorder, schizophrenia, or generalized anxiety disorder. current problem with major depressive disorder. current use of alcohol or other durgs on a daily basis. history of major medical illnesses. currently on parole, probation or a legal history of violence. treated for chemical dependency within the past 6 months. use of any psychotropic drugs including maois in the past 6 months.

Keywords: cocaine dependence
utility of rotem® for risk stratification of post-invasive procedure hemorrhage in patients with cirrhosis (cir-rotem)

Conditions: Cirrhosis, Liver

Summary: the assessment of post-procedural bleeding risk in cirrhosis remains a clinical challenge due to the lack of precise predictive tools and its high associated mortality. although guidelines recommend a restrictive transfusion policy, adherence remains low, with a high rate of prophylactic transfusions despite unclear benefits. this multicenter, prospective, and observational study will evaluate the utility of rotem in bleeding risk stratification for cirrhotic patients with significant abnormalities in conventional hemostasis tests undergoing high-risk invasive procedures. the primary objective is to establish cut-off values with a high negative predictive value, optimizing transfusion decisions and reducing unnecessary blood product use. additionally, the study will analyze the relationship between rotem, inflammation biomarkers, and coagulation factors, along with a cost-effectiveness analysis comparing different transfusion strategies. this will be the largest study to date assessing rotem in this setting, overcoming the limitations of previous studies, which have been mostly retrospective with heterogeneous populations and procedures. its findings could contribute to the standardization of transfusion management in cirrhosis and improve healthcare resource efficiency. the widespread availability of rotem in other disciplines within the national health system will facilitate its implementation in this clinical setting without requiring additional investment in equipment.


Eligibility criteria:
inclusion criteria: * age between 18 and 85 years. * clinical, analytical, elastographic, histological, and/or imaging criteria consistent with the diagnosis of hepatic cirrhosis. * undergoing a high-risk invasive procedure, either in an outpatient setting or during hospitalization. * platelet count below 50,000/μl or inr greater than 1.5 with a platelet count below 100,000/μl. * signature of informed consent. exclusion criteria: * cirrhotic patients with acute-on-chronic liver failure (aclf) as defined by easl criteria, and patients admitted to intensive care units. these patients are excluded because hemostatic alterations in aclf and critically ill patients are different and more pronounced compared to those in outpatient or general medical ward settings. * chronic kidney disease stage ≥3. * presence and/or history of thromboembolic complications. * presence of non-hepatic tumors. * presence of any primary hematologic disease (including inherited coagulopathies or thrombophilia). * recent surgery (\<8 weeks). * history of organ transplantation, including liver transplantation. * pregnancy. * use of anticoagulants, antiplatelet agents other than acetylsalicylic acid, and/or antifibrinolytic therapy. * active disseminated intravascular coagulation.

Keywords: hemorrhage viscoelastic tests rotational thromboelastometry
analysis of factors associated with the occurrence of amniotic fluid entry in patients undergoing caesarean section

Conditions: Amniotic Fluid Embolism

Summary: to compare serum stn （neuraminic acid-n-acetylgalactose）antigen concentrations in patients undergoing cesarean section and to study the factors associated with amniotic fluid entry.compare the serum complement c4 concentration in patients in the amniotic fluid admission group with those in the non-admission group to study whether amniotic fluid admission triggers the body's immune response.to record the patients' blood pressure, heart rate, blood oxygen, and the occurrence of related symptoms and adverse reactions at the time of admission, at the time of blood collection, at the time of discharge from the room, and at the time of the occurrence of haemodynamic changes.

all patients were routinely fasted for 8 h and abstained from drinking for 4 h. after entering the operating theatre, intravenous access was opened, and blood pressure, heart rate, electrocardiogram, oxygen saturation and patient's symptoms were continuously monitored during the operation. after obtaining informed consent for anaesthesia from the patient and his family, intrathecal anaesthesia or general anaesthesia was administered according to the situation. venous blood was drawn from the patient 30 min after the foetus was dissected out, and samples were preserved to measure the concentration of serum stn antigen and the concentration of complement c4; data were collected through the resident workstation system and the manual anaesthesia system, and the patient's information included age, history of allergy, number of deliveries, and history of combining with other illnesses; and the pregnancy information included placenta type, amniotic fluid, hypertensive disorders of pregnancy, and whether or not the pregnancy was multiple; delivery data included whether or not elective caesarean section was performed, operator factors, intensity of contractions, method of rupture of membranes, and anaesthesia method.

Eligibility criteria:
inclusion criteria: * approved consent and informed consent of the patient by the ethics committee of the second hospital of shanxi medical university; * asa classification of i-iii; * age 20-50 years old; * no previous history of psychiatric diseases or psychotropic drugs; exclusion criteria: * suffer from diseases of the cardiorespiratory system; * those with communication difficulties who were unable to complete the screening questionnaire;
telesonography for visually estimating ejection fraction

Conditions: Heart Failure, Systolic

Summary: background: given that an experienced physician is not always available 24 hours a day, immediately and always available echocardiography is usually impossible in the emergency department (ed) and intensive care unit (icu). to compensate this limitation, the investigators have investigated that offsite expert guided, inexperienced practitioner-performed ultrasonography could be effectively performed. in this study, the investigators aimed to investigate whether the offsite expert can effectively evaluate the visually estimated ejection fraction (ef) while watching and guiding the echocardiographic procedure of onsite novice examiner using the social network video calling chat. methods: sixty patients presenting to the icu and requiring echocardiography will be included. sixty novice practitioners without any previous experience of echocardiography will participate. prior to their procedure, the onsite expert complete the echocardiography in advance and determine the ef using the modified simpson's method (msm, reference value). then, the novice physicians perform the echocardiography again with the offsite expert's guidance via video call. they obtain parasternal long and short axis view and ef is visually estimated to the nearest 5% (ex. 40%, 45% and etc) by the offsite expert while watching the ultrasound video on the smartphone display. the subjects requiring immediate management due to severe symptoms were excluded in this study. interobserver variability between the calculated by onsite expert and visually estimated by offsite expert was assessed. the agreement of the visual estimated ef obtained by onsite expert and offsite expert via smartphone was evaluated by linear regression and bland-altman plots.


Eligibility criteria:
inclusion criteria: * the patients admit to intensive care unit exclusion criteria: * hemodynamic unstable patients * patients requiring immediate management
fraction dose escalation of split-course hypofractionated concurrent chemoradiotherapy following induction chemo-immunotherapy in unresectable locally advanced esophageal squamous carcinoma: a phase i study.

Conditions: Esophageal Squamous Cell Carcinoma

Summary: this phase i study is to determine the maximum tolerated fraction dose (mtd) for split-course hypo-ccrt following induction chemo-immunotherapy in la-escc patients, to clarify the dosimetric advantage of split-course hypo-ccrt, and to investigate the treatment-related toxicities and quality of life of the new regimen.

this phase i study is to determine the maximum tolerated fraction dose (mtd) for split-course hypo-ccrt following induction chemo-immunotherapy in la-escc patients, to clarify the dosimetric advantage of split-course hypo-ccrt, and to investigate the treatment-related toxicities and quality of life of the new regimen.

Eligibility criteria:
inclusion criteria: * histologically confirmed escc * ii-ivb stages (ivb stage only with metastatic celiac or supraclavicular lymph nodes) based on the tnm staging system proposed by the international union against cancer (uicc 2002) * eastern cooperative oncology group (ecog) performance status score 0-1 * charlson comorbidity index score≤4 * oral medication can be administered despite esophageal obstruction * adequate hematological, renal and hepatic functions exclusion criteria: * contraindication for radiotherapy or chemotherapy * prior malignancies, except for curable non-melanoma skin cancer or cervical carcinoma in situ * distant metastasis, except for celiac or supraclavicular lymph nodes metastases

Keywords: split-course hypofractionated concurrent chemoradiotherapy fraction dose escalation induction chemo-immunotherapy unresectable locally advanced esophageal squamous carcinoma
the natural history of injury-related disuse osteopenia

Conditions: Osteopenia

Summary: determine the severity and time course (natural history) of disuse osteopenia that occurs in the lower extremity(ies) and lumbar spine of patients sustaining lower extremity injuries that require the patient to maintain restricted weight bearing status (12 weeks) following the surgical fixation of the patient's injuries. the investigators hypothesize that there will be a significant decrease in the bone mineral density in the lower limbs of patients undergoing restricted weight bearing for peri-articular injuries of the lower extremity. this loss of bone mineral density is often prolonged in its duration and may lower subsequent fracture threshold and prolong the time to recovery and return to activities.

it is well documented that restricted weight bearing even for relatively short periods (12 weeks) associated with the surgical treatment of peri-articular injuries of the lower extremity (ie acetabulum, distal femur, tibial plateau, pilon, talus, calcaneus) can lead to a measurable decrease in bone density in the injured limb. furthermore, this osteopenia can persist for extended periods of time - much longer than the original period of restricted weight bearing. this relative osteopenia can delay recovery from injury, lower fracture threshold for subsequent injury and potentially delay return to active duty in the case of a wounded warrior. there exists a significant body of research in the modulation of the osteopenia associated with restricted weight bearing as it pertains to long term space flight (microgravity).

Eligibility criteria:
inclusion criteria: 1. age 18-70 at time of injury 2. previously normal community ambulator (without ambulatory aid) prior to injury exclusion criteria: 1. presence of a total or hemi hip prosthesis in the injured extremity 2. presence of lumbar fusion l1-l4 3. previous ipsilateral lower extremity trauma 4. history of medical treatment for known osteoporosis (calcium and vitamin d supplementation alone is not an exclusion criteria) 5. ambulatory dysfunction prior to injury 6. inability to cooperate with dxa scanning 7. head injury on admission requiring invasive monitoring or treatment 8. inability to adhere to weight bearing restrictions 9. inability to provide consent 10. non english speaking 11. pregnancy
long-term impact on cardiopulmonary function and quality of life in patients recovered from covid-19.

Conditions: COVID-19

Summary: function is an observational cohort study conducted by researchers from the instituto de medicina tropical alexander von humboldt at universidad peruana cayetano heredia and cayetano heredia hospital. the overall aim is to asses the long-term impact of sars-cov-2 infection on the cardiopulmonary function and quality of life in patients recovered from covid-19, through a 6-month follow-up structured in 4 visits with clinical assessments and imaging studies performed by specialists.


Eligibility criteria:
inclusion criteria: * individuals must meet all of the following criteria (either for group a or b) in order to participate in the study: * individuals of any sex over 18 years of age * a positive covid-19 test result by nasopharyngeal swab for either rt-pcr or antigenic techniques within the last 14 days prior the enrollment. a laboratory-based confirmatory report will be required * recruitment time close around the discharge date or no longer than 7 days after discharge * group a: individuals who had not reported signs or symptoms suggestive of covid-19 infection * group b: individuals who had reported signs or symptoms suggestive of covid-19 infection exclusion criteria: * an individual meeting any of the following criteria at the time of enrollment will be excluded from study participation: * a negative covid-19 test result by nasopharyngeal swab for either rt-pcr or antigenic techniques * known inability to keep adherent to the study (ex. incarceration, migration, travel) * active pregnancy confirmed by either qualitative urine or quantitative blood beta-hcg test

Keywords: covid-19 sars-cov-2 cardiovascular function respiratory function life quality long covid covid19 sequelae function test
laparoscopic ultrasound in diagnosing patients with pancreatic cancer

Conditions: Pancreatic Cancer

Summary: rationale: new diagnostic procedures, such as laparoscopic ultrasound, may improve the ability to detect pancreatic cancer and determine the extent of disease. purpose: phase ii trial to study the effectiveness of laparoscopic ultrasound in diagnosing patients with stage i or stage ii pancreatic cancer.

objectives: i. determine whether a comprehensive laparoscopic examination of the abdomen with laparoscopic ultrasonography improves staging of pancreatic cancer with respect to (a) better assessment (compared to ct) of the extent of localized extra pancreatic disease, (b) vascular invasion, (c) regional lymph node involvement, and (d) metastatic deposits in liver parenchyma. ii. assess whether one of the newer minimally invasive imaging techniques, laparoscopic ultrasonography, predicts vascular invasion in pancreatic cancer. iii. develop an optimal cost effective strategy for assessing resectability in pancreatic cancer. outline: patients who have undergone routine clinical staging (ct scan, angiogram, etc.) and who have been classified as potentially resectable undergo laparoscopy and laparoscopic ultrasound (l+lus). at the end of the l+lus, based on the new findings patients are reclassified as either potentially resectable or potentially unresectable. all patient then undergo definitive staging: those who have metastasis to the liver that can be pathologically confirmed by biopsy at the time of the laparoscopy are classified as unresectable and do not undergo laparotomy; all others undergo laparotomy and then are classified as resectable or unresectable. if 8 or more patients are misclassified at the time of the l+lus, then this study is terminated. projected accrual: there will be 50 patients accrued into this study with 25 patients in each stage. in order to accrue 50 patients, approximately 70 patients will undergo the initial routine clinical staging (ct scan, angiogram, etc.).

Eligibility criteria:
disease characteristics: histological or radiological evidence of stage i or ii pancreatic cancer no evidence of metastatic disease on ct scan patient characteristics: age: over 18 performance status: ecog 0-2 life expectancy: not specified hematopoietic: not specified hepatic: not specified renal: not specified cardiovascular: no prohibitive anesthetic risk due to cardiac disease pulmonary: no prohibitive anesthetic risk due to respiratory disease prior concurrent therapy: biologic therapy: not specified chemotherapy: not specified endocrine therapy: not specified radiotherapy: not specified surgery: no adhesions from previous surgery that preclude laparoscopy

Keywords: stage i pancreatic cancer stage ii pancreatic cancer
intensive meditation and migraines: effects on health and well being

Conditions: Chronic Daily Headache

Summary: participants completing training in intensive meditation and continuing frequent practice for one year would experience reduced frequency, duration and severity of headaches along with improved awareness of the triggers of their symptoms, improved quality of life and mental health, improved heart rate variability, and reduced inflammation.


Eligibility criteria:
inclusion criteria: * chronic daily headache, defined as a headache at least 15 days of the month, of which at least 8 are migraines. exclusion criteria:1. * severe depression, anxiety, panic attacks, psychosis or dementia that may interfere with ability to participate in a 10 day course * active alcoholism on screening or use of illicit drugs within the last 3 months * already completed a 10 day course * actively involved in another form of meditation over the past 6 months * women who are pregnant, planning pregnancy during trial period, or lactating.

Keywords: migraine headache vipassana meditation intensive