Kornimate/medical-research-clean huggingface dataset:
exosome-based liquid biopsies for upper gastrointestinal cancers diagnosis

Conditions: Gastric Cancer; Esophagus Cancer

Summary: this study constitutes a case-control investigation employing a retrospective approach. plasma samples from individuals with esophageal cancer, benign esophageal diseases, gastric cancer, benign gastric diseases, and a healthy control group were systematically collected. advanced data-independent acquisition (dia) proteomics and single-vesicle membrane protein detection techniques were employed to quantify protein content within exosomes. specific protein biomarkers indicative of early-stage upper gastrointestinal tumors were identified. external validation of these protein markers was conducted using parallel reaction monitoring (prm) technology on an independent validation cohort. the objective is to establish protein marker predictions for early diagnosis of upper gastrointestinal tumors and prognostication of therapeutic efficacy.

this study employs a multicenter, retrospective cohort design, collecting and analyzing plasma and tissue exosome protein data from patients with upper gastrointestinal tumors (stage i-ii), upper gastrointestinal benign diseases, and a healthy control group who have visited beijing friendship hospital, and other relevant sub-center hospitals over the past five years. concurrently, relevant clinical and pathological information is recorded. samples from the training cohort undergo traditional quantitative exosome proteomic analysis (data-independent acquisition, dia) and single-vesicle membrane protein analysis (pba). a comprehensive upper gastrointestinal tumor-specific exosome protein database is constructed, incorporating extensive information. subsequently, bioinformatics methods are employed to conduct in-depth analysis of the extensive protein data, screening for proteins with high specificity for upper gastrointestinal tumors, capable of direct detection on the exosome membrane surface. by establishing and evaluating diagnostic models, we aim to quantify the diagnostic potential of these markers, providing a scientific basis for future early screening methods for upper gastrointestinal tumors. finally, external validation of these protein markers in an independent validation cohort ensures their reliability and stability across different patient populations. the academic significance of this research lies in its thorough exploration of exosome proteomics in early cancer diagnosis, offering potential innovative breakthroughs for academic progress and clinical practice in this field.

Eligibility criteria:
inclusion criteria: * confirmed diagnosis of upper gastrointestinal cancers or benign upper gastrointestinal diseases through gastroscopy and pathological examination. * collection of plasma samples prior to surgical treatment. * availability of complete clinical data. exclusion criteria: * previous reception of anti-tumor treatments (including radiotherapy, chemotherapy, etc.) before blood collection. * coexistence of other systemic tumors. * absence of plasma sample collection before surgical treatment. * incomplete clinical data. * pregnancy status
a safety and efficacy study of ispronicline (tc-1734-112) in subjects with age associated memory impairment (aami)

Conditions: Age-Related Memory Disorders

Summary: the purpose of this phase ii study is to evaluate the efficacy and safety of ispronicline (tc-1734-112) compared to placebo (inactive substance pill) in patients with age associated memory impairment (aami). aami is characterized as cognitive impairment including memory loss and poor concentration associated with aging.


Eligibility criteria:
inclusion criteria: * male or female subjects aged 50-80 years. * lives with a significant other. * has subjective memory complaints. verbal verification of this subjective memory complaint will be obtained from the significant other. * has no severe, uncontrolled medical condition. * if receiving treatment for a medical condition, that treatment has been stable for at least 2 months before entering the trial and to remain stable throughout the trial. exclusion criteria * aged less than 50 years or greater than 80 years. * lives alone. * has any medical condition not adequately controlled, or likely to interfere with performance of the study procedures. * medication for a medical condition has been changed in the last 2 months or during the trial. * administration of acetylcholinesterase inhibitors and gingko biloba within 2 months prior to entering the study. * has evidence of depression or anxiety * meets dsm-iv criteria for alzheimer's or vascular dementia. * has participated in an investigational drug trial in the previous 30 days.

Keywords: aami memory impairment decline in cognitive function age associated memory impairment
immunogenicity and safety study of gsk biologicals' herpes zoster vaccine with various formulations in adults >= 50 years

Conditions: Herpes Zoster

Summary: the goal of this randomized observer-blind trial is to further refine the formulation of vaccines containing gsk1437173a in older adults by comparing the cellular and humoral immune responses and the safety profiles of the different formulations.


Eligibility criteria:
inclusion criteria: * a male or female 50 years of age or above at the time of the first vaccination; * written informed consent obtained from the subject; * subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study; * if the subject is female, she must be of non-childbearing potential, or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for 2 months after completion of the vaccination series. exclusion criteria: * use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period; * chronic administration (defined as more than 14 consecutive days) of immunosuppressants or other immune-modifying drugs within three months prior to the first vaccine dose. * planned administration/ administration of a vaccine not foreseen by the study protocol within one month before the first study vaccination or scheduled within 30 days after study vaccination; * previous vaccination against hz; * previous vaccination against varicella; * history of hz; * history of allergic disease or reactions likely to be exacerbated by any component of the vaccine; * any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease or immunosuppressive/cytotoxic therapy; * administration of immunoglobulins and/or any blood products within the 3 months preceding the first injection of study vaccine or planned administration during the study period; * acute disease at the time of enrolment. * any other condition that, in the opinion of the investigator, might interfere with the evaluations required by the study; * history of or current drug and/or alcohol abuse; * pregnant or lactating female; * female planning to become pregnant or planning to discontinue contraceptive precautions if of childbearing potential.

Keywords: cytokine vaccine herpes zoster (hz) cell mediated immunity (cmi) antibody response varicella zoster virus (vzv) shingles
ultrasound-guided monopolar versus bipolar radiofrequency ablation for genicular nerves in chronic knee osteoarthritis

Conditions: Chronic Knee Osteoarthritis

Summary: radiofrequency ablation of the genicular nerves using ultrasound is safe and effective for treating intractable knee osteoarthritis pain by using either monopolar or bipolar radiofrequency ablation. this technique is based on anatomical studies demonstrating that genicular nerves are accompanied by genicular arteries. ultrasound-guided rf genicular ablation yielded both significant reductions in knee pain and improvements in functional capacity.

the aim of this study is to compare between ultrasound guided monopolar and bipolar radiofrequency ablation in chronic knee osteoarthritis. osteoarthritis of knee joint is one of the most common disease conditions with advanced age and leads to considerable morbidity in terms of pain, stiffness, limitation in functions, disturbance in sleep and psychological disturbance a diagnostic genicular nerve block (gnb) with local anesthetic is performed before rf genicular ablation, and a successful response to gnb is considered to indicate the need for rf genicular ablation

Eligibility criteria:
inclusion criteria: * radiologic tibiofemoral osteoarthritis (kellgren-lawrence grade 2-4). * patients not responding to other treatments as physiotherapy, oral analgesics, and intraarticular injection with hyaluronic acids or steroids. * patients refused surgery. exclusion criteria: * patient refusal. * prior knee surgery. * acute knee pain. * intra-articular knee corticosteroid or hyaluronic acid injection in the past 3 months. * connective tissue diseases that affected the knee. * anticoagulant medication use. * local skin infection and sepsis at the site of intervention
investigation of the efficacy and safety of drotrecogin alfa (activated) in pediatric severe sepsis

Conditions: Sepsis

Summary: the purposes of this study are to determine: 1. whether drotrecogin alfa (activated) helps children with severe sepsis survive their condition more often or recover faster than children who do not receive drotrecogin alfa (activated). 2. whether drotrecogin alfa (activated) minimizes long term disabilities associated with severe sepsis. 3. the side effects that might be associated with drotrecogin alfa (activated) administration to children with severe sepsis.

the primary objective was to demonstrate that drotrecogin alfa (activated) compared with placebo reduced severe-sepsis-induced organ dysfunction as assessed by time to complete resolution of a composite of cardiovascular, respiratory, and renal organ failure in pediatric patients with severe sepsis. secondary objectives included: (1) to assess whether treatment with drotrecogin alfa (activated) reduced 28-day all-cause mortality in pediatric patients with severe sepsis compared with placebo patients, (2) to evaluate the effects of drotrecogin alfa (activated) on individual organ dysfunction (cardiovascular, respiratory, renal, hepatic, hematologic, neurologic, and cutaneous), (3) to demonstrate that drotrecogin alfa (activated) improved patient outcome as assessed by the pediatric overall performance category (popc) scale, (4) to demonstrate that drotrecogin alfa (activated) reduced major amputations (at or above the wrist, at or above the ankle, face, and genitals) in pediatric patients with neisseria meningitidis (proven or suspected) and/or purpura fulminans, (5) to demonstrate that drotrecogin alfa (activated) had antithrombotic and anti-inflammatory properties. the safety objective was to evaluate whether drotrecogin alfa (activated) had an acceptable safety profile when administered to pediatric patients with severe sepsis.

Eligibility criteria:
inclusion criteria: * suspected or proven acute infection. * abnormally high or low core body temperature * cardiovascular dysfunction which requires the use of vasoactive drugs (such as, dopamine, dobutamine, epinephrine) and is the result of severe sepsis. * respiratory dysfunction which requires the use of mechanical ventilation and is the result of severe sepsis. exclusion criteria: * patients at increased risk of bleeding. * patients at high risk for an intracranial bleed. * patients who have undergone a bone marrow transplant. * patients with end-stage renal disease. * patients whose family or primary care physician is unwilling to allow transfusion of blood products.
a phase 1 study of zl-1218 in subjects with advanced solid tumors

Conditions: Malignant Solid Tumor

Summary: the purpose of this study is to characterize the safety, tolerability, pharmacokinetics (pk), pharmacodynamics (pd), and preliminary antitumor activity of zl-1218 as a single agent and as combination therapy in subjects with advanced solid tumor malignancies.


Eligibility criteria:
inclusion criteria: * adult men and women ≥ 18 years of age. if 18 years is not the age of majority, then adult men and women ≥ age of majority per local regulation. * eastern cooperative oncology group (ecog) performance status of 0-1. * life expectancy \> 12 weeks. * subjects must have histologically confirmed and documented diagnosis of locally advanced unresectable or metastatic advanced solid tumor that is refractory to standard treatment, or intolerant to standard treatment, or for which no standard treatment exists.subjects must have at least one target lesion as defined by recist v1.1 on ct, pet/ct, or mri scan. * subjects must have a site of disease which is not previously irradiated and is safe and amenable to biopsy per the treating institution's guidelines. subjects must be willing to undergo a tumor biopsy at screening and on treatment, per the protocol guidelines. * subjects must have a site of disease which is not previously irradiated and is safe and amenable to biopsy per the treating institution's guidelines. subjects must be willing to undergo a tumor biopsy at screening and on treatment, per the protocol guidelines. exclusion criteria: * symptomatic or uncontrolled brain metastasis requiring concurrent treatment, inclusive of but not limited to surgery, radiation, and/or corticosteroids. * prior exposure to ccr8 inhibitor (anti-ccr8 antibody) or hypersensitivity to any ingredient of the study drug. * out of range value within 10 days prior to the first dose of study treatment. * subjects have received a live or live-attenuated vaccine within 30 days of planned start of study therapy. * subjects with known history of, or any evidence of active, non-infectious pneumonitis. * impaired cardiac function or clinically significant cardiac disease within the last 3 months before administration of the first dose of the study drug. * treatment with any systemic anti-cancer treatment (including investigational products) within 4 weeks before first dose of study drug. * non-palliative radiotherapy within 2 weeks prior to first dose of study drug or have had history of radiation pneumonitis. * major surgery within 4 weeks of the first dose of study drug. * infections requiring systemic antibiotic therapy. * any medical conditions that would, in the investigator's judgement, prevent the subject's participation in the clinical study due to safety concerns, compliance with the study procedures, or interpretation of the study results.
biomarkers for diagnosis of lung nodules

Conditions: Lung Abscess

Summary: a need exists for non-invasive testing to aid in clinical decision-making for computerized tomography (ct) scan detected lung nodules of indeterminate etiology. the investigators hypothesize that biomarkers detectable in blood, sputum or urine may be useful for guiding clinical decisions in the setting of ct detected lung nodules to determine which nodules are malignant and which are benign. the investigators also hypothesize that these biomarkers will decrease in concentration to the normal range after successful surgical treatment of malignant lung nodules.

the biomarkers for diagnosis of lung nodules study is a prospective study of a cohort of 500 individuals with lung nodules of indeterminate etiology that are identified by ct scans. either biopsy or repeat ct scans must be clinically indicated to determine the etiology of the nodule. patients will be asked to allow investigators access to ct scan images and spirometry data, and provide blood, sputum, urine, and exhaled breath samples over the course of the study. patients will also be asked to allow investigators to access pathology records if a biopsy or surgical excision of the nodule is clinically indicated.

Eligibility criteria:
inclusion criteria: 1. adult 18-85 years of age 2. patients referred to pulmonologists, oncologists, or thoracic surgeons for the evaluation of peripheral lung nodules found on ct scan. 3. repeat ct scans, biopsy or surgical excision are clinically indicated to determine the etiology of the nodule. 4. one or more lung nodules must be between 8 mm and 30 mm in the greatest diameter. 5. patients must be fully informed of the investigational nature of the procedure and sign an informed consent. - exclusion criteria: 1. lung nodules or masses greater than 30 mm in the greatest dimension. 2. lung nodules that have solid calcification. 3. lung nodules or masses with ct evidence of partial or complete obstruction of a lobar bronchus, main stem bronchus or the trachea. 4. no prior cancer with the exception of non-melanoma skin cancer. 5. life expectancy of \< 6 months 6. any individual who does not give oral and written consent for participation -

Keywords: lung nodules a need exists for non-invasive testing to aid in clinical decision-making for ct scan detected lung nodules of indeterminate etiology.
diagnostic value of optical enhancement technology in early esophageal squamous neoplasia

Conditions: Early Esophageal Squamous Neoplasia

Summary: the aims of the present study： 1. to investigate the diagnosing value of optical enhancement technology for early esophageal squamous neoplasia. 2. to assess the detection rate of early esophageal squamous neoplasia by virtual chromoendoscopy with optical enhancement technology .

detection and differentiation of esophageal squamous neoplasia (esn) are of value in improving patient outcomes.optical enhancement technology can serves in the diagnosis of gi neoplasia. however, its performance in esn has not yet been reported.the aims of the present study is: 1. to investigate the diagnosing value of optical enhancement technology for early esophageal squamous neoplasia. 2. to assess the detection rate of early esophageal squamous neoplasia by virtual chromoendoscopy with optical enhancement technology .

Eligibility criteria:
inclusion criteria: 1. patients with high-risk factors for esophageal squamous cell carcinoma who meet any of follows： * long term living in the high incidence area of esophageal squamous cell carcinoma ； * first degree relatives have a history of esophageal squamous cell carcinoma ； * previous history of esophageal lesions （ esophageal squamous neoplasia ）； * the patients having a history of cancer； * a long history of smoking ； * a long history of drinking ； * having bad eating habits such as eating fast, hot diet, high salt diet, eating pickles. 2. patients aged between 40 to 74 years old. exclusion criteria: 1. having advanced esophageal carcinoma; 2. after esophageal surgery or endoscopic treatment ; 3. known esophageal radiotherapy or chemotherapy ; 4. esophageal stenosis; 5. acute bleeding; 6. a known allergy to iodine; 7. coagulopathy (prothrombin time \ 50 seconds); 8. having food retention; 9. severe hepatic ,renal, cardiovascular or metabolic dysfunction ; 10. being pregnant or lactating;

Keywords: early esophageal squamous neoplasia optical enhancement technology virtual chromoendoscopy
pilot study evaluating the safety and efficacy of open-label olanzapine

Conditions: Bipolar Disorder

Summary: inpatient study evaluating the safety and efficacy of open-label olanzapine monotherapy in treatment refractory bipolar mania: this study recruits adult subjects who are diagnosed with bipolar i disorder and presently experiencing an episode of mania. patients must be willing to spend initial 7 days in the hospital to observe response to medication. patients must be refractory (intolerant or non-responsive) to treatment with lithium and valproate or carbamazepine. patients receive study-related care at no cost. this study is sponsored by eli lilly and company.


Eligibility criteria:
inclusion criteria: * the subject satisfied diagnostic and statistical manual of mental disorders, 4th edition (dsm-iv) criteria for a primary diagnosis of bipolar disorder, most recently manic * the patient is willing to be hospitalized on an inpatient psychiatric unit for a minimum of seven (7) days. * subject has been treated with lithium in the past. * subject has been treated with divalproex or carbamazepine in the past. * subject has been treated with haldol or haloperidol in the past. exclusion criteria: * subjects lacks the capacity to provide informed consent * subject is a serious suicide risk or has medically unstable conditions as judged by the investigators * subject has been dependent on a drug (other than nicotine or caffeine) in the last three (3) months.
the molecular biology of paroxysmal nocturnal hemoglobinuria (pnh)

Conditions: Hemoglobinuria, Paroxysmal

Summary: this study is designed to better understand the molecular biology of paroxysmal nocturnal hemoglobinuria (pnh) and to determine if prion protein (prp) functions in long term hematopoietic stem cell renewal.

paroxysmal nocturnal hemoglobinuria (pnh) is characterized by hemolytic anemia, thrombosis, and variable cytopenia. it can be associated with significant morbidity including acute kidney failure, cerebral infarction, mesenteric infarction, budd-chiari syndrome, aplastic anemia, and leukemic transformation. the average survival time from diagnosis is 15 years. pnh is an acquired clonal disorder of the hematopoietic stem cell. two distinct populations of hematopoietic cells exist in each pnh patient: one non-clonal population of normal cells, and one clonal population of pnh cells. the clonal population of pnh cells is identified by a mutation in the pig-a gene that results in absence of the glycophosphatidylinositol (gpi) anchor of several surface proteins. consequently, these surface proteins are unable to perform their functions on the cell surface. deficiency of two of these surface proteins, cd55 (decay accelerating factor) and cd59 (membrane inhibitor of reactive lysis) that prevent complement mediated destruction, have been shown to underlie the clinical presentation of pnh. identifying the mutation causing the predominant clones may help us better understand the molecular biology of pnh. when this is accomplished, new therapies to control and eventually cure the disease can be designed. in addition, we propose to determine the function of prp in human hematopoietic stem cells. prp is a glycoprotein attached to the cell membrane by a glycosylphosphatidylinositol (gpi) anchor. in pnh, a disorder whose pathogenesis lies in the absence of gpi anchors, prp expression is reduced in monocytes and granulocytes from the pnh clone.

Eligibility criteria:
inclusion criteria: 1. subjects suspected of or diagnosed with paroxysmal nocturnal hemoglobinuria (pnh) 2. age \> 7 exclusion criteria: 1. those not meeting the inclusion criteria

Keywords: paroxysmal nocturnal hemoglobinuria pig-a mutation prion protein hematopoietic stem cells clonal disorder