Kornimate/medical-research-clean huggingface dataset:
concordance of inivata liquid biopsy with standard tissue biopsy

Conditions: Non-Small Cell Lung Cancer

Summary: this study aims to look at a comparison of liquid biopsy (blood sample) analysis compared with tissue biopsy in patients with advanced lung cancer

the primary aim of this study is to investigate the concordance of inivata liquid biopsy panel with standard tissue biopsy analysis for detecting genomic alterations in patients with advanced non-squamous non-small cell lung cancer (nsclc).

Eligibility criteria:
inclusion criteria: * written, signed and dated informed consent * male \& female patients aged 18 years and over diagnosed with stage iiib/iv non-squamous nsclc. * patients intended to initiate first-line treatment (arms a and b) * patients who plan to have or have had a recent tumor tissue biopsy taken as part of their standard of care (arm a) * patient must understand and be able, willing and likely to fully comply with all study procedures and restrictions. exclusion criteria: * patients who have received any approved or experimental cancer therapy since their most recent nsclc tissue biopsy * any history of metastatic cancer. * previous malignancy in the last 2 years (except basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix). * patient with a severe acute or chronic medical or psychiatric condition or laboratory abnormality

Keywords: lung cancer biopsy
effect of multimodal opioid-free anesthesia on return of bowel function in laparoscopic colorectal surgery

Conditions: Anesthesia; General Anesthesia; Analgesics, Opioid; Opioid Free Anesthesia; Postoperative Ileus; Colorectal Surgery; Laparoscopic Surgery; Analgesia; Dexmedetomidine; Lidocaine; Ketamine

Summary: the objective of this study is to determine if an opioid-free general anesthetic (ofa) technique utilizing lidocaine, ketamine, dexmedetomidine and magnesium reduce postoperative opioid consumption and speed return of bowel function in patients undergoing elective, laparoscopic, colorectal surgery compared to traditional opioid-containing general anesthetic techniques. it is hypothesized that this intraoperative ofa regimen will reduce postoperative opioid consumption, and expedite return of bowel function in this population.

the objective of this trial is to determine whether an opioid-free general anesthetic can help reduce postoperative opioid consumption and speed return of bowel function in patients undergoing elective, laparoscopic, colorectal surgery when compared with traditional opioid-containing techniques.

Eligibility criteria:
inclusion criteria: * age \> 18, american society of anesthesiology (asa) class i-iii patients scheduled for elective laparoscopic/laparoscopic assisted colorectal surgery exclusion criteria: * emergency surgery, open surgery, contraindications to laparoscopic surgery (ie. adhesions, inability to tolerate pneumoperitoneum), american society of anesthesiology (asa) class 4, age \< 18, pregnant or breastfeeding women, significant cardiorespiratory/hepatic/renal disease, allergy to any study drugs, inability to consent, inability to respond to pain assessments, inability to use the patient controlled analgesia device (pca)

Keywords: opioid-free opioid-sparing
redifferentiation therapy using alpha lipoic acid in thyroid cancer

Conditions: Thyroid; Cancer

Summary: radioiodine (i-131) therapy is of proven efficacy for treatment of differentiated thyroid carcinoma (dtc). however, loss of differentiation in recurrent or metastatic dtc which decrease i-131 uptake may decrease the efficacy of i-131 therapy. therefore, strategies to improve i-131 uptake are mandatory. this study is an open label clinical study to evaluate the effectiveness of alpha-lipoic acid (ala) for improving i-131 uptake in recurrent or metastatic of dtc with defective i-131 uptake.


Eligibility criteria:
inclusion criteria: 1. aged 20 to 75 years 2. under birth control, if fertile women 3. groups * who received radioactive iodine treatment for recurrent and metastatic thyroid cancer, and did not showed any uptake at post-therapeutic whole body scan * who planned to receive empirical radioactive treatment due to high expected recurrence exclusion criteria: * allergic to alpha-lipoic acid * severe heart failure, lung disease, or end-stage renal disease * liver function abnormalities (x2.5 above normal limits) * neuropsychologically unstable patients * previous history of drug medication such as oral steroid, digoxin, theophylline, carbamazepine, valproic acid, phenobarbital, methotrexate, cyclosporin, tacrolimus within 3 months before this recruitment. * who is already taking alpha-lipoic acid for other purpose.

Keywords: thyroid cancer redifferentiation lipoic acid
a pilot study of the efficacy of alli in the management of pre-operative weight loss required for bariatric surgery.

Conditions: Obesity

Summary: the primary goal of the study is to determine if orlistat 60mg (alli) is effective in helping patients achieve a required 10% weight loss goal prior to bariatric surgery. the medication will be added to the usual standard of care which includes education regarding diet and exercise and monthly meetings with a registered dietician.


Eligibility criteria:
inclusion criteria: * adult patients preparing for gastric bypass surgery exclusion criteria: * pregnancy

Keywords: gastric bypass surgery
effects of ethanol on intestinal permeability and integrity

Conditions: Healthy

Summary: alcohol consumption is a major health problem worldwide. it affects all systems of the body especially the gastrointestinal tract. acute or chronic alcohol consumption has deleterious effects on the gastrointestinal mucosa vary from increased intestinal permeability, structural changes to sever destruction of the epithelial lining cells. human data are still limited and most of the studies were performed in chronic alcohol abusers. the investigators hypothesize that moderate alcohol drinking also may increase small intestinal permeability and contribute to the subsequent disruption of the tight junction complex. this study may provide more insight into the effects of moderate alcohol drinking on the small intestinal permeability.


Eligibility criteria:
inclusion criteria: * signed informed consent form. * male gender to avoid the gender-related differences in ethanol metabolism. * between 18-45 years to avoid age-related changes in ethanol metabolism39. * normal medical history and physical examination. * normal liver function tests (i.e. alt, ast, and γgt) according to the reference values for normal ranges of the liver enzymes at the laboratory of clinical chemistry of the maastricht university medical center. * caucasian ethnicity. * bmi=18 - 30 kg/m2. exclusion criteria: * history of gastro-intestinal disorders or abdominal surgery. * history of alcohol abuse or current excessive alcohol consumption (\> 2 alcoholic beverages per day or \> 14 alcoholic beverages per week)40. * recent or chronic medications that may interact with ethanol metabolism or intestinal permeability i.e., nsaids, benzodiazepines and antidepressants. * smoking.

Keywords: permeability tight junctions cytokines inflammatory bowel diseases the effect of alcohol on the intestinal permeability may have major consequences on health. it's generally accepted that an increased intestinal permeability in alcoholic subjects lead to translocation of bacterial endotoxins from the gut lumen into the portal vein and then to the liver. in the liver, endotoxins trigger the immune system and activate the resident macrophages, kupffer cells. activation of kupffer cells leads to production of chemokines (il-8) and proinflammatory cytokines (il-1, tnfα),resulting in hepatocytes damage, inflammation, fibrosis and finally cirrhosis.
budesonide prophylaxis for engraftment syndrome after hematopoietic cell transplantation

Conditions: Engraftment Syndrome

Summary: the purpose of this study is to determine if budesonide prophylaxis starting day 5 after transplant reduces engraftment fever in autologous and allogeneic stem cell transplant recipients.


Eligibility criteria:
inclusion criteria: * • patients 18-80 years of age with a diagnosis of a hematological malignancy * meet the bmt program criteria to undergo hematopoietic stem cell transplantation for hematologi malignancies exclusion criteria: * • patients enrolled in investigational clinical trials * sct for non hematologic malignancies
veno-venous extracorporeal co2 removal in ards-patients to treat respiratory acidosis

Conditions: ACUTE RESPIRATORY DISTRESS SYNDROME

Summary: hypothesis: extracorporeal removal of co2 can treat hypercapnia and respiratory acidosis, which allows application of lung protective ventilation. this downgrading of mechanical ventilation promotes better and more quickly lung recovery. aim: the aim of the study is to treat respiratory acidosis and to reduce plateau pressures by using an extracorporeal removal of co2 (ecco2-r). this prospective study will include 10 patients with an acute respiratory distress syndrome (ards). ards is an inflammatory response in the lungs, the onset is acute with pulmonary oedema and shows bilateral densities on chest radiography. the take up of oxygen and the loss of co2 in the lungs are difficult. moreover the patient's blood can become acidic due to too much co2. to promote a better gas-exchange, the patient with ards will be mechanically ventilated. this can be aggressive and harmful for the lungs. with the use of an extra-corporeal co2-remover, co2 can be removed so that the mechanical ventilation setting will be less aggressive and will decrease lesions in the lung. the veno-venous extracorporeal co2-remover pumps blood from a vein via a catheter through an oxygenator (gas exchanger that adds oxygen to the blood and extracts carbon dioxide from the blood) and back into a vein. the investigators will use a standard dialysis catheter that will be put in a large vein. to prevent clotting of the system, the patient will receive heparin. in the study the investigators will work in periods of two hours, the situation before and after carbon dioxide removal will be compared. with this study the investigators want to prove that the co2 in the blood decreases with at least 20 % with the use of the extracorporeal co2 remover. more over the investigators want to prove that lower mechanical ventilation settings (thanks to co2-removal by the ecco2-r) will produce fewer lesions to the lungs.


Eligibility criteria:
inclusion criteria: * acute onset of ards criteria on chest x-ray or ct scan * moderate (pao2/ fio2 \<200) or severe ards (pao2/ fio2 \<100) (fio2: fraction of inspired oxygen) * respiratory acidosis with ph\< 7,25, * with plateau pressure of 28cmh20 or higher, exclusion criteria: * \<18 years of age * pregnancy * obesity with bmi\> 30 * contraindication for anticlotting therapy * chest wall abnormalities * no presumed consent of representatives
treating acute mi patients with aggrastat on their way to hospital

Conditions: Acute Myocardial Infarction

Summary: treating an ami patient with st elevation with aggrastat in the ambulance on his or her way to the hospital.


Eligibility criteria:
inclusion criteria: patients with acute myocardial infarction with st elevation , and moving by ambulance to poriya hospital exclusion criteria: * women less than 50 years old and 80 years old, bleeding tendency, stroke in the past
study of t900607-sodium in chemotherapy naive patients with hepatocellular carcinoma.

Conditions: Hepatocellular Carcinoma

Summary: the purpose of the study is to determine whether t900607-sodium is effective and safe in treating hepatocellular carcinoma, a type of liver cancer.


Eligibility criteria:
inclusion criteria * histologically or cytologically confirmed diagnosis of hcc * child-pugh liver classification of a or b * subjects must not have received prior chemotherapy or radiotherapy for their hcc * at least 18 years of age * bidimensionally measurable disease amenable to ct scanning. at least one lesion must be least 1 x 1 cm in size. * karnofsky performance status of at least 70% * estimated life expectancy of at least 12 weeks * females of childbearing potential must have a negative pregnancy test and agree to use an effective contraceptive * subject must be able to comply with study procedures and follow-up examinations. * signed written informed consent * lab values (obtained ≤ 7 days prior to study enrollment): * anc at least 1.5x10e9/l, * platelet count at least 100x10e9/l, * creatinine within 2 times upper limit of normal * ast and alt within 5 times upper limit of normal * bilirubin within 1.5 times upper limit of normal * albumin great than 2.8 g/dl exclusion criteria * severe, concurrent disease, infection or co-morbidity that, in the judgment of the investigator, would make the subject inappropriate for enrollment * nyha class iii/iv cardiac disease, left ventricular ejection fraction (lvef) of \<50%, or acute anginal symptoms * patients who have received any investigational agent within 4 weeks of enrollment * patients who are pregnant or breast-feeding * history of prior malignancy other than cancer studied within the last 5 years, except for adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix * history of central nervous system metastases or carcinomatous meningitis * major surgery within 4 weeks of enrollment * patients who have received prior chemotherapy, chemoembolization, immunotherapy, or radiotherapy for their hcc. prior surgical resection, intratumoral ethanol injection, hormonal therapy, cryosurgery, radiofrequency ablation, selective internal radiation or embolization, is permitted only if \> 6 weeks has passed since therapy and there is an indicator lesion (\> 1 x 1 cm) outside the area of prior treatment (recurrence at the margin or resection is allowed)

Keywords: hcc
median effective dose of lidocaine for the prevention of pain caused by the injection of propofol formulated with medium-/long-chain triglycerides

Conditions: Lidocaine; Injection Pain

Summary: propofol is widely used in general anesthesia induction, but the occurrence of peripheral intravenous pain is relatively high, causing anxiety, fear and other adverse emotions in patients , aggravating the stress response, and even leading to adverse events of cardiovascular system . the use of mediate-long chain fat emulsion propofol partly reduces the incidence of injection pain but patients can still suffer from different degrees of pain. advanced intravenous injection of lidocaine can alleviate the pain of propofol injection, but its application method and dose are controversial. it is worthy of further discussion on how to select the appropriate dose of advanced intravenous injection of lidocaine to effectively prevent the injection pain of mediate-long chain fat emulsion propofol, and simultaneously avoid the adverse reactions of intravenous lidocaine, thus improving patient satisfaction and perioperative safety. in this study, in order to provide clinical references, sequential method was used to find the median effective dose (ed50) by means of pre-intravenous injection of lidocaine to suppress pain in mediate-long chain fat emulsion propofol injection.


Eligibility criteria:
inclusion criteria: * ages ranged from 18 to 65. * asa ⅰ or ⅱ level. exclusion criteria: * allergy or contraindication to lidocaine or propofol; required for central venipuncture catheterization; * abnormal liver or kidney function; * heavy drinking and long-term use of sedatives, analgesics or anti-anxiety drugs; * hearing and language impairment; * peripheral vascular disease; * severe cardiovascular disease or neurological disorders; * failure of one-time peripheral venipuncture; * infection of hand or wrist skin.
interview time: training inspired minds for employment

Conditions: Autism Spectrum Disorder

Summary: the purpose of the study is to see if an internet job interview training program can help people that have autism improve interview skills and access to jobs. participants will be randomized to use virtual interview training (vit) or continue services as usual (active control group).

participants will have assessments that will be done over the computer or in-person at school or program site. assessments will be about participants background, employment history, mood and feelings, autistic traits, memory, mental health issues, such as depression and anxiety, and other things. some assessments will be audio and/or video recorded. please note that there will be teachers and staff consented (approximately n=32) to deliver the intervention, however, will not count for the clinical trial. therefore, the information will not be added to the anticipated enrollment numbers in study design.

Eligibility criteria:
inclusion criteria: * participants have a diagnosis on the autism spectrum * participants are enrolled in pre-employment transition services * participants have at least a third-grade reading level * are unemployed or employed and job-seeking exclusion criteria: - not enrolled in pre-employment transition services

Keywords: job interview skills students
gut microbiota and alzheimer's diseases

Conditions: Alzheimer Disease

Summary: the investigator will perform clinical studies to test a hypothesis that participants who have alzheimer's disease will have different gut/oral microbiota profile as compared to the participants who do not have alzheimer's disease. the investigators will also check the microbiome of their partners in this study. the investigators plan to perform the studies in 150 participants in shanghai tenth's people's hospital and also in the houses in shanghai city. investigators will also measure the beta-amyloid in the feces of the participants. finally, the investigators will determine cognitive function in these participants.

studies have shown that gut/oral microbiome and beta-amyloid in body may have a significant impact on the behavior and brain pathology consistent with alzheimer's disease (ad) neuropathogenesis. the objective of this study is to assess whether the gut/oral microbiome and feces beta-amyloid of ad patients are different from those of the participants without ad and their partners. the investigators plan to recruit 150 subjects, including three groups of normal elders, ad patients and the partners of the ad patients. the cognitive function will be assessed and the feces and oral samples will be collected to determine whether there are differences or correlations.

Eligibility criteria:
inclusion criteria: * aged 60 and older exclusion criteria: * with other acute gastrointestinal diseases * with other severe neuropsychiatric disorders

Keywords: gut microbiota alzheimer's diseases
train your brain: neurofeedback intervention for ptsd

Conditions: Stress Disorders, Post-Traumatic

Summary: the investigator's aim is to evaluate the efficacy of two types of neurofeedback treatments for ptsd symptoms reduction. half of the participants will receive the current standard for ptsd neurofeedback care undergoing alpha/theta neurofeedback regulation. the other half will receive the newly developed limbic modulation index neurofeedback.

traumatic stress is commonly resistant to existing therapeutics, possibly due to high treatment dropout rates along with a failure to target the relevant underlying neural mechanisms. neuromodulation of deep limbic areas such as the amygdala may play a critical role in the effective recovery from traumatic stress. human studies have shown the importance of such modulation during the encoding of traumatic stimuli, showing greater amygdala activation for subsequently remembered traumatic stimuli. in addition, a prospective study among previously healthy soldiers showed that hyper-activation of the amygdala prior to military traumatic exposure corresponded with more severe post-traumatic symptoms following exposure. together these finding points to the amygdala as a plausible neuromodulation target for preventive or early interventions of post-traumatic disturbances. local neuromodulation of the amygdala could improve treatment specificity and the overall intervention outcome. the main goal of the suggested research is to further develop and implement a non-invasive, portable and cost-effective brain-imaging tool that will provide individual on-line guidance for amygdala modulation. this closed-loop brain training will enhance individual resilience to and coping with potentially traumatic stress as well as alleviate consequential psychopathologies.

Eligibility criteria:
inclusion criteria: * previous diagnosis of ptsd * ptsd symptoms within the last 30 days exclusion criteria: * any active psychosis or suicidal intent * a severe traumatic brain injury (one in which consciousness was lost for greater than 6 hours) * any of the following neurological disorders: parkinson's, alzheimer's, brain tumor, or brain lesion.

Keywords: ptsd post-traumatic stress disorder acute stress syndrome emotion regulation depression anxiety sexual assault combat ptsd
a study to evaluate the safety and pharmacokinetics after oral concurrent administration of fimasartan and hydrochlorothiazide in healthy male volunteers

Conditions: Essential Hypertension

Summary: to evaluate drug-drug interaction between fimasartan and hydrochlorothiazide.

fimasartan (br-a-657-k), a selective blocker of at1 receptor subtype, showed the rapid and potent antihypertensive effect in many hypertensive models. phase i study, fimasartan (br-a-657-k) 20 mg \~ 480 mg single dosing with healthy subjects, demonstrated that the fimasartan (br-a-657-k) was very safe and well tolerated. another phase i study, fimasartan (br-a-657-k) 120mg and 360mg dosing for 7 days, also showed that fimasartan (br-a-657-k) was safe and tolerable though one temporal adverse event was observed in high dose. a open-labeled, multiple-dosing, crossover, parallel clinical study to evaluate drug-drug interaction between fimasartan and hydrochlorothiazide. 34 male healthy volunteers were enrolled during 2 months. in part a, 240 mg of fimasartan per day was taken for 1 week. after 7 day washout period, 240 mg of fimasartan and 25mg of hydrochlorothiazide per day were taken for 1 week. then blood and urine samples were collected 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 and 24 hours at 7 day and 21 day. in part b, 25 mg of hydrochlorothiazide per day was taken for 1 week. after 7 day washout period, 240 mg of fimasartan and 25mg of hydrochlorothiazide per day were taken for 1 week. then blood and urine samples were collected 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 and 24 hours at 7 day and 21 day.

Eligibility criteria:
inclusion criteria: * age: 20 - 45 years * sex: male * body weight: greater than 55 kg * written informed consent exclusion criteria: * known allergy to fimasartan and hydrochlorothiazide * existing cardiac or hematological diseases * existing hepatic and renal diseases * existing gastrointestinal diseases * acute or chronic diseases which could affect drug absorption or metabolism * history of any serious psychological disorder * positive drug or alcohol screening * smokers of 10 or more cigarettes per day 3 month ago * participation in a clinical trial during the last 2 months prior to the start of the study

Keywords: fimasartan drug interaction