Kornimate/medical-research-clean huggingface dataset:
comparison trial of white light, autofluorescence and narrow band imaging bronchoscopy

Conditions: Lung Cancer

Summary: the purpose of the study is to compare the three methods of bronchoscopic imaging to determine what combination is optimum to identify neoplastic mucosal abnormalities. the ability to decrease the rate of false-positive and false negative findings of bronchoscopy also will be studied for each spectroscopic technique separately and for their combination.

patients with known or suspected malignancies of the lung and with a medical indication for a bronchoscopy will be invited to participate in the study. all patients must be over 18 years old and must sign informed consent. the endoscopic examination of the bronchial tree will be performed using a commercially available flexible fluorescence bronchoscope (11004bi; karl storz; culver city, ca) and the flexible white light video-bronchoscope (bf-t180; olympus; center valley, pa). images obtained will be photographed using both video recordings and parallel images of white light and imaged bronchoscopy. these digital images will be electronically stored and evaluated at a later time. biopsies will be obtained of all suspected abnormalities. these will be correlated with the images. images will be identified as normal, suspect or abnormal based upon each modality independently, paired with the spectral image and all three combined. the control will be an area considered normal by all modes of bronchoscopy. images will be graded at the time of bronchoscopy. later, all images will be graded in a blind fashion by two independent bronchoscopists. standard statistical analysis using paired student's t test will be applied. we anticipate that the combination of one or more imaged bronchoscopy techniques will increase accuracy by 25%. power calculation to detect such a difference will require 140 abnormal specimens. if 50% of patients examined have an abnormality, the study population will need to be around 300 patients. histopathology reports will be obtained on all specimens. abnormal results will be discussed with the individual patient and appropriate procedures will be performed based upon best medical practices. these procedures and patient follow-up are beyond the scope of the study.

Eligibility criteria:
inclusion criteria: * patients with lung abnormalities that have an indication for bronchoscopy exclusion criteria: * inability to tolerate bronchoscopy

Keywords: bronchoscopy endoscopy image enhancement autofluorescence narrow band image
hiv exposure in utero and metabolic disease risk in hiv-negative young adults

Conditions: HIV-exposed Uninfected

Summary: globally, over 1 million babies are born to mothers with hiv each year. with the advent of prenatal antiretroviral therapy, up to 98% of these individuals may be hiv-exposed uninfected (heu). a growing literature suggests that in utero hiv exposure - even in the absence of subsequent infection - may be associated with adverse health outcomes in infancy and childhood. however, there is little information about the long-term health implications of in utero hiv exposure later in life, such as into adulthood. in this study, for the first time, we seek to prospectively evaluate metabolic and immune indices among heu young adults as compared to well-matched hiv-unexposed uninfected controls. this study serves as a necessary first step toward optimizing clinical care for this expanding and aging heu population, including the implementation of novel screening and prevention strategies.


Eligibility criteria:
inclusion criteria: hiv-exposed uninfected (heu) mother-young adult dyads 1. male or female young adult, 18-35 years old 2. documentation of hiv infection in mother with date of diagnosis preceding young adult birth date 3. negative hiv test in young adult control mother-young adult dyads 1. matching to heu dyad 2. negative hiv test in mother and young adult exclusion criteria: all young adults 1. pregnancy within 6 months or active nursing 2. change in blood glucose or blood pressure medication within 3 months 3. change in estrogen or testosterone therapy within 3 months 4. chronic glucocorticoids (except steroid inhalers or creams) within 3 months 5. antiretroviral therapy use within 6 months (i.e., prophylaxis) 6. significant chronic illness judged by the investigator to represent a contraindication to participation

Keywords: hiv-exposed uninfected in utero exposure metabolic immune
a clinical study to evaluate the clinical outcomes of hepatectomy with nutritional risk after preoperative nutritional support

Conditions: Liver Cancer

Summary: objective:to study the clinical outcomes of hepatectomy with nutritional risk after preoperative nutritional support. study design: 1.prospective，randomized, controlled clinical study;2.patients: the subjects were from peking union medical college hospital (pumch). study arrangement: 1. the collection of patients with selected standard 2. preoperative evaluation included nutritional status,liver function and tumor characteristics 3. the experimental group received preoperative nutritional support for 4 days,the control group got nothing 4. both groups received conventional therapy after operation 5. the comparation of the clinical outcomes in both groups


Eligibility criteria:
inclusion criteria: 1. a diagnosis of hepatocellular carcinoma (hcc) was made before operation 2. nutritional risk screening 2002(nrs-2002) was greater or equal 3 points with in 24 hours after admission

Keywords: liver tumor
haph registry: time course and prognostic significance of pulmonary artery pressure in highlanders.

Conditions: High Altitude Pulmonary Hypertension; Sleep Apnea

Summary: the purpose of the current study is to evaluate the clinical and physiologic course of kyrgyz highlanders with high altitude pulmonary hypertension (haph) by performing a longitudinal cohort study. to this end, the investigators will invite the same highlanders who participate din the study in 2017 to undergo follow-up examinations in 2024, in order to allow comparisons of current results with baseline data from 2017.


Eligibility criteria:
inclusion criteria: * permanently living \>2500 m * written informed consent exclusion criteria: * highlanders who cannot follow the study investigations, * patients with moderate to severe concomitant lung disease (fev1\ 20 cigarettes/day or \>20 pack-years. * coexistent unstable systemic hypertension or coronary artery disease that required adjustment of medication within the last 2 months * regular use of medication that affects control of breathing (benzodiazepines, opioids, acetazolamide)

Keywords: high altitude illness pulmonary hypertension sleep apnea disease progression hypoxia
chidamide combination with lenalidomide in patients with relapsed or refractory peripheral t-cell lymphoma

Conditions: Relapsed or Refractory Peripheral T-cell Lymphoma

Summary: the purpose of this open label,single arm,phase ⅱ clinical trail is to determine the safety and efficacy of chidamide combination with lenalidomide for relapsed or refractory peripheral t-cell lymphoma.

histone deacetylase(hdac) inhibitor has been used in relapsed or refractory peripheral t-cell lymphoma.there are no international studies of chidamide combination with lenalidomide for relapsed or refractory peripheral t-cell lymphoma. therefore, this study intends to select the oral hdac inhibitor chidamide combined with lenalidomide for relapsed or refractory peripheral t-cell lymphoma, and explore its efficacy and safety.

Eligibility criteria:
inclusion criteria: * peripheral t cell lymphoma (ptcl); * no remission or relapse after at least one previous systemic treatment； * at least one assessable lesion； * 18-75 years; * ecog ps 0-2; * proper functioning of the major organs; * expected survival time ≥3 months. exclusion criteria: * previous received treatment of hdac inhibitor or lenalidomide; * central nervous system (cns) involvement; * serious heart problems; * known allergies to experimental drug ingredients; * diagnosed with or receiving treatment for a malignancy other than lymphoma; * uncontrolled active infection, with the exception of tumor-related b-symptom fever; * unable or unwilling to receive antithrombotic therapy; * history of deep vein thrombosis (dvt) or pulmonary embolism (pe) in the past 12 months;
thromboelastogram in postdelivery preeclamptic patients

Conditions: Preeclampsia; Coagulation Disorder; Pregnancy Complications

Summary: there are no studies evaluating the effect of aging on hemostasis of preeclamptic patients. additionally, although there are some studies that establish normal reference values for teg profiles in healthy term pregnant patients, conflicting results have been found in preeclampsia. reference values are important to establish baseline parameters in cases of pre-eclampsia complicated by postpartum hemorrhage. the investigators will evaluate reference values for teg in postdelivery preeclamptic patients and the difference between vaginal delivery and cesarean section.

after approval by the institutional review board and informed consent from participants, the investigators are obtaining blood samples for teg processing, from pregnant patients admitted to the maternity unit of augusta university medical center. patients are being classified in 2 groups: term pregnant patients with diagnosis of pre-eclampsia who undergo cesarean section and those having spontaneous vaginal delivery. each group will be divided into subgroups according to maternal age: 18-25 years, 26-35 years, \>36 years. pre-eclampsia is defined and classified according to the definitions of the american college of obstetricians and gynecologists published in 2013.

Eligibility criteria:
inclusion criteria: * age \> 18 years mental competence gestational age \> 37-week informed consent diagnosis of preeclampsia (with or without features of severity) exclusion criteria: gestational age \ 35 maternal comorbid conditions other than preeclampsia
mer-tk in human cardiac cells

Conditions: Myocardial Inflammation; Myocardial Infarction

Summary: the relationship between the immune system and the myocardium after myocardial ischemia is an evolving field of research. crosstalk occurs between macrophages and cardiac myocytes to promote cardio-protection and resolution of inflammation after myocardial ischemia and reperfusion injury (mi/r injury). myeloid-epithelial-reproductive tyrosine kinase (mertk), a member of the tam family of tyrosine kinase receptors (tyro-axl-mertk), is a macrophage receptor that mediates efferocytosis, anti-inflammatory signaling, and resolution of inflammation. after mi/r injury, intact mertk is necessary for the phagocytosis of dead cardiac myocytes and to promote anti-inflammatory signaling. proteolytic cleavage of mertk to its inactive form, soluble mer, restricts the capacity of macrophages to phagocytize dead cardiac myocytes and impairs mertk-dependent anti-inflammatory signaling resulting in suppressive effects on cardiac remodeling and function. the thorp lab at northwestern university has previously measured soluble mer levels in both adult mice and humans and found that soluble mer concentrations increase after mi/r injury. in adult mi patients, soluble mer was measured post coronary artery reperfusion and was found to be increased (average 3200 pg/ml compared to 1700 pg/ml) compared to controls with stable cardiovascular disease. based on murine data, the lab further postulated that reperfusion injury may directly interfere with mertk-dependent cardiac repair as reactive oxygen species formed during reperfusion injury induce proteolytic cleavage of mertk to soluble mer. myocardial infarctions are rare events in pediatric patients. however, pediatric hearts are exposed to periods of hypoperfusion, ischemia, and inflammation during times of stress such as cardiac bypass and critical illness, and it is unknown how soluble mer levels change in response to these events. thus, i was interested in investigating how soluble mer levels change after mi/r injury induced by cardiac bypass as well as in the utility of soluble mer as a biomarker of cardiac inflammation and injury in pediatric patients.


Eligibility criteria:
inclusion criteria: * all patient ages from birth-19 years-old as well as cyanotic and acyanotic cardiac lesions will be included exclusion criteria: * patients will be excluded if both pre and post bypass blood samples are not available.
cross-cultural adaptation and validity of mini bestest in balance disorders in the autonomous city of buenos aires: validation study protocol

Conditions: Vestibular Disease; Peripheral Vestibular Disorder

Summary: the objective of this study is to carry out the cross-cultural adaptation of the mini bestest (a balance assessment scale) into argentine spanish, as well as to study its validation in patients with peripheral vestibular disorders in the autonomous city of buenos aires.


Eligibility criteria:
inclusion criteria: * subjects \>18 years of age, * with vestibular alterations of peripheral etiology, within the second year of evolution * time of evolution of symptoms ≤ 2 years * independent walking with or without walking assistance device * who are at the beginning of a vr program * no diagnoses of psychiatric disorders or cognitive impairment, * sign the informed consent exclusion criteria: * who have suffered amputation in one of their lower limbs, * history of neurological pathologies (stroke, multiple sclerosis, neuromuscular disease)
parvovirus h-1 (parvoryx) in patients with progressive primary or recurrent glioblastoma multiforme.

Conditions: Glioblastoma Multiforme

Summary: investigation on safety, tolerability and efficacy of h-1 parvovirus (h-1pv) in subjects suffering from glioblastoma multiforme.

investigation on safety, tolerability and efficacy of h-1 parvovirus (h-1pv) in subjects suffering from glioblastoma multiforme. h-1pv will primarily be administered either intratumoral or intravenously. ten days thereafter a complete or a subtotal tumor resection with a subsequent administration of h-1pv into the walls of the resection cavity will be carried out.

Eligibility criteria:
inclusion criteria: * age over or equal to 18 years old, * diagnosis of glioblastoma multiforme, * written informed consent, * recurrent or progressive disease despite previous radio- and/or chemotherapy, * indication for complete or subtotal tumor resection, * life expectancy of at least 3 months, * consent for sampling and investigation of biological specimens, * karnofsky performance score over or equal to 60, * adequate seizure control, * adequate bone marrow function: neutrophils \> 1.5 x 10exp9/l, platelets \> 100 x 10exp9/l, hemoglobin \> 9.0 g/dl, * adequate liver function: bilirubin \< 2.0 g/dl, asat, alat, ap, ggt \< 3 x uln, * adequate renal function: creatinine \< 1.8 g/dl, * adequate blood clotting: aptt \< 35 sec, inr \< 1.2, * negative serology for hiv, hbv and hcv, * negative beta-hcg test in women of childbearing potential, * commitment to use adequate contraception (in both genders) for up to six months after study entry, * commitment to omit exposure to infants \< 18 months of age or immunocompromised individuals for up to 28 day after first administration of imp. exclusion criteria: * multifocal disease, * evidence of distant tumor metastases, * contraindications for mri, * active infection within 5 days prior to the study inclusion, * chemotherapy within 4 weeks prior to the study inclusion, * radiotherapy within 6 weeks prior to the study inclusion, * participation in another interventional trial within the last 30 days, * treatment with antiangiogenic substances within 21 days prior to therapy.

Keywords: progressive glioblastoma multiforme recurrent glioblastoma multiforme oncolytic virus
testosterone replacement therapy and liraglutide effects on weight loss in hypogonadism.

Conditions: Hypogonadism; Obesity

Summary: the purpose of this study was to compare the effects of liraglutide and testosterone replacement therapy on features of hypogonadism and weight loss in obese men with persistent features of hypogonadism after unsuccessful lifestyle measures.


Eligibility criteria:
an extension study to assess the long-term safety and efficacy of pasireotide in participants with acromegaly

Conditions: Acromegaly

Summary: acromegaly is a rare, serious condition characterized by chronic hypersecretion of growth hormone (gh), generally caused by a gh-secreting pituitary adenoma. the study assessed the long-term safety and efficacy of pasireotide in participants with acromegaly.


Eligibility criteria:
inclusion criteria: * participants who have completed all four treatment regimens in the core study csom230b2201 (nct00088582) and achieved biochemical control in growth hormone (gh) and insulin-like growth factor-1 (igf-1) levels after at least one month of pasireotide administration at any of the three doses. * participants who did not experience any unacceptable adverse events or tolerability issues during the core study csom230b2201. exclusion criteria: * participants who experienced or developed compression of the optic chiasm causing any visual field defect during the core study csom230b2201. * participants who required a surgical intervention for relief of any sign or symptom associated with tumor compression during the core study csom230b2201. * participants who experienced or developed congestive heart failure, unstable angina, sustained ventricular tachycardia, ventricular fibrillation or acute myocardial infraction during the core study csom230b2201. other protocol-defined inclusion/exclusion criteria may apply.

Keywords: acromegaly pasireotide gh igf-1
multicentre prospective clinical trial for rfa tumour aspirator treatment of primary and secondary malignancies of the liver

Conditions: Liver Cancer

Summary: the primary aim for this trial is to assess whether the rfa aspirator device is safe and of clinical benefit in patients with primary or secondary malignant liver tumours

patients with unresectable primary or secondary malignancies of the liver have limited treatment options which often only give a small survival benefit. rfa has been demonstrated to be effective in local tumour eradication and to extend patient survival. in this study rfa aspiration will be used to treat unresectable primary or secondary tumours of the liver. rfa will be used to develop a shell of tissue destruction around the tumour, with aspiration removing tissue and fluid from the centre of the lesion. the potential advantages of aspirating during ablation could be to reduce aerosol spread of tumour within the liver parenchyma and peritoneum. additionally, aspirating the ablated tissue may reduce the incidence of systemic side effects related to rfa when larger lesions are treated. this study would establish the safety and efficiacy of rfa aspiration in the treatment of unresectable primary/secondary malignancies of the liver. this protocol is for a prospective multi-centre clinical trial of the use of rfa aspiration in the treatment of patients with primary/secondary malignancies of the liver, which are not suitable for formal liver resection. the basis for unresectability being the presence of extra-hepatic disease, limited liver synthetic function, co-morbidity (asa\>3), bilobar disease and anatomical location. early and late complications relating to the usage of the rfa aspirator will be analysed. additionally, local recurrence and long term survival will be assessed. if the use of the rfa aspirator produces improved survival with minimal morbidity and mortality. then these initial results will justify further in depth studies to establish its clinical role. ii. specific aims/objectives the primary aim for this trial is to assess whether the rfa aspirator device is safe and of clinical benefit in patients with primary or secondary malignant liver tumours. iii. study overview it is anticipated that 100-200 participants will be recruited. the time period for patient recruitment will be for 2 years with follow up for 3 years. the total study period will be 5 years in order to allow the assessment of complications, local ablation success and survival benefit.

Eligibility criteria:
inclusion criteria: * eligible participants will be 18 years and older. * have unresectable primary/secondary malignant tumours of the liver. unresectable criteria being the presence of extra-hepatic disease, limited liver synthetic function, co-morbidity (asa 3), bilobar disease and anatomical location. * study specific signed informed consent will also have to be completed to allow patient inclusion. exclusion criteria: * age younger than 18 years old * pregnant women * uncorrectable coagulopathy

Keywords: radiofrequency ablation liver cancer complications liver tumors
coagulation in acute aortic dissection

Conditions: Acute Aortic Dissection; Coagulation Disorder

Summary: acute aortic dissection (aad) involving the ascending aorta (stanford classification type a) remains a life-threatening disease. excessive perioperative bleeding requiring massive transfusion of allogeneic blood products, and surgical reexploration remain major challenges in these patients. previous research has indicated that patients with aad show pronounced haemostatic alterations prior to surgery which are aggravated during major aortic surgery with cardiopulmonary bypass and hypothermia full heparinization. intensified anticoagulation management guided by heparin dose response (hdr) calculation, and repeated measurement of heparin concentration may be more effective than standard empiric weight-based heparin and protamine management monitored by activated clotting time (act) measurements to suppress thrombin generation during surgery for aad. this randomized controlled clinical trial compares the impact of two recommended anticoagulation management strategies during surgery for aad including deep hypothermia on activation of coagulation: heparin/protamine-management based on hdr-titration by means of hms plus® versus current institutional standard (hdr- versus act-approach). primary endpoint is thrombin generation as measured by early postoperative prothrombin fragment 1+2 (f1+2). secondary endpoints are other markers of coagulation and fibrinolysis as well as clinical outcome.

hypotheses: primary: hdr-approach is superior to act-approach in terms of suppressing thrombin generation after emergent surgery for acute aortic dissection (stanford type a). secondary: hdr-approach is superior with regard to * early postoperative haemostatic capacity * requirement of blood product transfusion and haemostatic agents * postoperative bleeding design: investigator-initiated, single-site, parallel-group (1:1), prospective, randomized, partially double-blinded trial in patients undergoing emergent surgery for acute aortic dissection comparing two heparin management strategies with superiority design. prior to randomization, patients are stratified according to preoperative organ dysfunction and anticoagulation therapy. acute research study design as patients with acute aortic dissection are considered incompetent according to the danish research ethics committees definition. deferred consent by the competent patient or her/his proxy (next of kin) and an independent physician) is used. 26 consecutive patients undergoing emergent surgery for acute aortic dissection (stanford type a) are randomized 1:1 into the following heparin management strategies with an act target of 480 seconds: * individualised hdr-approach * conventional act-approach no interim analysis. a sub-study to compare cost-benefit of both strategies is planned.

Eligibility criteria:
inclusion criteria: * age \> 18 years * emergent acute aortic dissection with cardiopulmonary bypass * incapable of providing informed consent exclusion criteria: * history of congenital coagulation disorder (haemophilia) * previous open cardiac surgery * death during induction of anaesthesia