Kornimate/medical-research-clean huggingface dataset:
haic combined with lenvatinib and sintilimab for hepatocellular carcinoma with pvtt

Conditions: Carcinoma, Hepatocellular; Liver Neoplasms; Sintilimab; Portal Vein Tumor Thrombus

Summary: this study intends to evaluate the efficacy and safety of hepatic arterial infusion chemotherapy of oxaliplatin, 5-fluorouracil and leucovorin plus lenvatinib and sintilimab for patients hepatocellular carcinoma and portal vein tumor thrombus.

hepatic arterial infusion chemotherapy (haic) of oxaliplatin, 5-fluorouracil and leucovorin was effective and safe for hepatocellular carcinoma. lenvatinib was non-inferior to sorafenib in overall survival in untreated advanced hepatocellular carcinoma, and sintilimab, an programmed cell death protein-1 (pd-1) antibody, was effective and tolerable in patients with hepatocellular carcinoma and portal vein tumor thrombus. no study has evaluated haic plus lenvatinib and sintilimab. thus, the investigators carried out this prospective, single-arm study to find out it.

Eligibility criteria:
inclusion criteria: * 1. clinical diagnosis of hcc; 2. age between18 and 75 years; 3. refused to sorafenib treatment; 4. type i pvtt, type ii pvtt, or type iii pvtt. 5. child-pugh class a or b; 6. eastern cooperative group performance status (ecog) score of 0-2; 7. hemoglobin ≥ 8.5 g/dl total bilirubin ≤ 30mmol/l serum albumin ≥ 32 g/l asl and ast ≤ 5 x upper limit of normal serum creatinine ≤ 1.5 x upper limit of normal inr ≤ 1.5 or pt/aptt within normal limits absolute neutrophil count (anc) \>1,500/mm3 8. prothrombin time ≤18s or international normalized ratio \< 1.7. 9. ability to understand the protocol and to agree to and sign a written informed consent document. exclusion criteria: * 1. diffuse hcc; 2. extrahepatic metastasis; 3. obstructive pvtt involving both the left and right portal vein or main portal vein. 4. serious medical comorbidities. 5. evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy 6. known history of hiv 7. history of organ allograft 8. known or suspected allergy to the investigational agents or any agent given in association with this trial. 9. cardiac ventricular arrhythmias requiring anti-arrhythmic therapy 10. evidence of bleeding diathesis. 11. patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.

Keywords: carcinoma, hepatocellular lenvatinib sintilimab portal vein tumor thrombus oxaliplatin 5-fluorouracil leucovorin
a clinical trial comparing oseltamivir with placebo and zanamivir with control as first line treatment for human swine influenza infection

Conditions: Upper Respiratory Tract Infection; Influenza

Summary: to evaluate the efficacy of oseltamivir ,as compared with the placebo arm and zanamivir with its control arm with respect to symptoms duration among patients infected with influenza a (h1n1) virus.

the outbreak of respiratory illnesses in mexico that began in march 2009 was caused by a swine origin influenza a (h1n1) virus (s-oiv) that had not been recognized previously in pigs or humans. as of 17 may 2009, 39 countries have officially reported 8480 cases of influenza a (h1n1) infection. the h1n1 influenza a virus appears sensitive to oseltamivir and zanamivir in vitro, but resistant to amantadine and rimantadine. this study is to test the oseltamivir, zanamivir and placebo arms as the first line treatment for human swine influenza infection. through the study, the investigators may have better understanding about the clinical and, biochemical, virological profiles of oseltamivir/zanamivir on the h1n1 virus, and optimizing the treatment strategy among the chinese population.

Eligibility criteria:
inclusion criteria: * male or female patients 18 years or older with body weight \>40kg * written informed consent * presented within 48 hours of onset of influenza-like illness * presumptive diagnosis of h1n1 satisfying the following clinical and laboratory criteria: * clinical criteria * fever \>38 oc (infrared forehead thermometer will be used to measure the temporal artery temperature under the skin) and * at least one upper respiratory tract infection (cough, running nose, sore throat) * laboratory criteria positive rapid test result for influenza a (by influenza rapid diagnostic test) within 48 hours of onset of flu-like symptoms exclusion criteria: * age below 18 years * persons who lack the ability to care for themselves * patient with critical condition or already developed severe respiratory distress with hypoxaemia on presentation * pregnancy or lactation * coexisting liver disease * coexisting cardiovascular disease except stable hypertension without complication * coexisting chronic pulmonary disease * coexisting immuno-compromised medical conditions or on concurrent immunosuppressive therapies * renal failure * terminal malignancies or terminal end-organ failure with an estimated life-expectancy of less than 3 months * known intolerance to oseltamivir or zanamivir * known history of significant neurological disorders that can compromise respiratory function or the handling of respiratory secretions or that can increase the risk for aspiration or those * subjects who have received oseltamivir as prophylaxis for h1n1 infection * subjects who have received any investigational drug within 1 month prior to study entry * subjects with a mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study

Keywords: upper respiratory tract infection influenza a human swine influenza
ropivacaine though laterosternal catheters after cardiac surgery

Conditions: Cardiac Surgery

Summary: this is a prospective double-blinded and randomised study involving patients undergoing cardiac surgery with median sternotomy, the effects on postoperative analgesia of a 48-hr continuous infusion of ropivacaine 2 mg.ml-1, at the rate of 4 ml.hr-1 through two catheters inserted at the lateral edges of the sternum will be studied, versus a control group in which normal saline will be infused in the same conditions.

diverse methods for infusion of local anaesthetics after cardiac surgery have been proposed, but none of them provided high-level evidence of efficacy. the catheters studied here are designed for a surgical insertion before closure of the sternotomy, with the aim of infusing the drug the closest possible of the terminations of intercostal nerves.

Eligibility criteria:
inclusion criteria: * scheduled cardiac surgery. exclusion criteria: * - surgery in emergency * thoracotomy * cardiac graft * redo * pregnancy * patient's refusal * minor or adult under legal protection * psychiatric ongoing disease * addiction to opiates * ongoing opiate treatment * inability to use a pca device * respiratory insuffiency (vital capacity or maximal expired volume per sec. \ 50 mmhg) * intra-aortic balloon * severe renal insuffiency * history of allergy or intolerance to: morphine, acetaminophen, bupivacaine.

Keywords: sternotomy pain respiratory function opiates patient-controlled scheduled cardiac surgery under general anaesthesia without any locoregional anaesthesia protocol other than this presently studied
krt-232 in subjects with relapsed or refractory small cell lung cancer

Conditions: Small-cell Lung Cancer; Small Cell Lung Carcinoma; Small Cell Lung Cancer Extensive Stage; Small Cell Lung Cancer Recurrent

Summary: this study evaluates krt-232, a novel oral small molecule inhibitor of mdm2, for the treatment of patients with relapsed or refractory small cell lung cancer. this study will be conducted in 2 parts. part 1 will evaluate two treatment arms, each with a different krt-232 dose. part 2 will continue the evaluation of the selected treatment arms from part 1.


Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed diagnosis of sclc documented as tp53wt * disease must be measurable per recist version 1.1 * evidence of radiographic progression during or after at least one prior platinum-containing therapy with no curative therapy available. subjects who have received only one prior line of therapy must not be candidates for platinum-based regimens at relapse. * subjects must have received a checkpoint inhibitor (pd-1 or pd-l1) unless contraindicated if checkpoint inhibitors are approved and available. * ecog ≤ 2 exclusion criteria: * symptomatic or uncontrolled central nervous system (cns) metastases. * prior treatment with mdm2 inhibitors * chemotherapy, immune therapy, cytokine therapy, or any investigational therapy within 14 days prior to the first dose of study treatment * grade 2 or higher qtc prolongation (\> 480 milliseconds per nci-ctcae criteria, version 5.0) * history of major organ transplant

Keywords: navtemadlin
virtual reality exposure therapy versus exposure in vivo for social phobia

Conditions: Social Anxiety Disorder; Social Phobia

Summary: the current study aims at comparing the efficacy of exposure in vivo and exposure via virtual reality for social anxiety disorder. 70 patients with social anxiety disorder will be randomized to either one of the active conditions or to a waiting-list condition. participants on the waiting-list will be offered either exposure in vivo of in virtual reality after a waiting period of five weeks. levels of psychopathology will be assessed at pre- and post-treatment as well as three and 12 months after treatment.


Eligibility criteria:
inclusion criteria: * 18 - 65 years old * a primary diagnosis of social anxiety disorder as measured with the scid * fluency in dutch. exclusion criteria: * psychotic episodes in the past, suicidal intentions or substance dependence. * behavior therapy in the preceding one year.

Keywords: social anxiety disorder social phobia virtual reality exposure
traumatic spinal cord injury: effects of corporal suspension and pendulum exercises

Conditions: Spinal Cord Injuries

Summary: the purpose of this study was to evaluate the effects of an exercise program proposed by the chordata® method on the functionality, maximal isometric torque, muscle activity and muscle thickness of trunk muscles in patients with traumatic spinal cord injury. the hypothesis is that the chordata® method could reduce the deleterious effects of the traumatic spinal cord injury.

participants were allocated into one of two groups (rehabilitation or control). rehabilitation group (8 weeks of rehabilitation; chordata® method) control group (patients with up to three years of traumatic spinal cord injury): participants maintained their daily-life activities routine during the same eight weeks period and were tested before and after this control period. at the end of the control period, patients interested at participating on the training program were included in the intervention group

Eligibility criteria:
inclusion criteria: - patients that suffered traumatic spinal cord injury in the last 42 months, capable of transporting themselves for rehabilitation at the physical therapy clinic and for the neuromuscular tests at the laboratory where measurements were performed. exclusion criteria: * body weight above 95kg * physical and functional limitations impeding them of performing physical activity * physically incapacitating diseases (e.g severe cardiovascular and respiratory diseases, neurodegenerative diseases, oncologic diseases, systemic arterial hypertension) * visual deficit that impeded reading * recurrent vertigo or hypotension to exercise * engaged in other treatments that could constitute a confounding effect * changed their daily life activities during the study

Keywords: spinal cord wounds and injuries rehabilitation
dose-response, safety and efficacy of febuxostat in subjects with gout

Conditions: Gout

Summary: the purpose of this study is to determine the efficacy of febuxostat, once daily (qd), in reducing serum urate levels in subjects with gout.

gout is a chronic urate crystal deposition disorder, which if left untreated may result in progressive disease characterized by joint and bone destruction from tophaceous deposits and renal impairment due to gouty nephropathy. hyperuricemia, defined as a serum urate concentration of \>7.0 milligrams per deciliter (mg/dl), is the underlying metabolic aberration leading to urate crystal deposition in gout. gout has several clinical presentations, including: recurrent acute attacks of inflammatory arthritis; deposition of monosodium urate monohydrate crystals in joints, bones and even parenchymal organs (tophaceous gout); renal impairment; and uric acid nephrolithiasis. as serum urate levels increase beyond \>7.0 mg/dl, the risks for gouty arthritis or for renal calculi increase. currently allopurinol is the only xanthine oxidase inhibitor available. allopurinol is the agent of choice for reduction of serum urate levels in patients with: uric acid overproduction; unresponsive or intolerant to uricosuric agents; impaired renal function; uric acid urolithiasis; or tophi. febuxostat (tmx-67) is a non-purine selective xanthine oxidase inhibitor being developed as an orally administered agent for management of hyperuricemia in patients with gout.

Eligibility criteria:
inclusion criteria: * hyperuricemia (serum uric acid ≥8.0 mg/dl). * must meet american college of rheumatology criteria for gout. * must have adequate renal function (serum creatinine \<1.5 mg/dl). * females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from screening throughout the duration of the study. exclusion criteria: * history of xanthinuria * alcohol consumption \>14/week * has a history of significant concomitant illness. * has active liver disease. * has a body mass index greater than 50 kilogram per meter² (kg/m²) * any other significant medical condition that would interfere with the treatment, safety or compliance with the protocol, as defined by the investigator.

Keywords: uric acid xanthine oxidase tophi drug therapy
pancreatic cancer detection consortium

Conditions: Pancreatic Cancer; Pancreatic Carcinoma; Pancreatic Adenocarcinoma; Pancreatic Ductal Adenocarcinoma; Pancreatic Neoplasms; Pancreatic Cancer Stage I; Pancreatic Cancer Stage; Pancreatic Cancer Resectable; Pancreatic Cancer Stage 0; Pancreatic Cancer Stage II; Pancreatic Cancer Stage III; Pancreatic Cancer, Adult; Pancreatic Cancer Non-resectable

Summary: this study aims to prospective validate an exosome-based mirna signature for noninvasive and early detection of pancreatic ductal adenocarcinoma.

pancreatic ductal adenocarcinoma (pdac) is one of the deadliest forms of cancer. it often goes undetected until it is at an advanced stage, making it challenging to treat. currently, only a small percentage of patients are diagnosed early enough for effective treatment. while a blood marker exists, called serum carbohydrate antigen 19-9 (ca19-9), it is used primarily to track the disease and it is unreliable for early detection. to address this problem, the researchers have developed a new method to analyze circulating vesicles (called exosomes), which contain specific genetic material called micrornas (mirnas). in a previous study, by analyzing both the mirnas that circulate freely in serum and the mirnas that are inside the exosomes, the researchers have already identified a combination of 13 mirnas that could accurately detect early-stage pdac. in this study, the researchers will test this method in a larger international cohort study. this study aims to confirm the effectiveness of this approach in accurately identifying pdac at its earliest stages.

Eligibility criteria:
inclusion criteria: * histological diagnosis of pancreatic ductal adenocarcinoma, stages i-iv (tnm classification, 8th edition) * received standard diagnostic and staging procedures as per local guidelines, and at least one sample was drawn before receiving any curative-intent treatment. * imaging- or endoscopy-based proof of lack of pancreatic ductal adenocarcinoma at the time of sampling (non-disease controls) exclusion criteria: * lack of written informed consent.

Keywords: micro rna exosome cell free early detection screening
assessing the efficacy and safety fo dextenza, sustained release dexamethasone 0.4 mg insert(s) for the treatment of pain, inflammation, and cystoid macular edema following 27 gauge vitrectomy with internal limiting membrane peel for the treatment of retinal edema associated with macular pucker.

Conditions: Vitrectomy; Macular Pucker; Retinal Edema

Summary: assessing the efficacy and safety of dextenza, sustained release dexamethasone 0.4 mg inserts following 27 gauge vitrectomy with internal limiting membrane peel

assessing the efficacy and safety of dextenza, sustained release dexamethasone 0.4 mg inserts, when placed within the lower eye lid canaliculus or both the upper and lower canaliculi for the treatment of pain, inflammation, and cystoid macular edema following 27 gauge vitrectomy with internal limiting membrane peel for the treatment of retinal edema associated with macular pucker

Eligibility criteria:
inclusion criteria: a patient's study eye must meet the following criteria to be eligible for inclusion in the study: * symptomatic macular pucker with retinal edema * age 18 years and older * scheduled vitrectomy and internal limiting membrane peel * willing and able to comply with clinic visits and study related procedures * willing and able to sign the informed consent form exclusion criteria: a patient who meets any of the following criteria will be excluded from the study: * patients under the age of 18 * pregnancy ( must be ruled out in women of child-bearing age with pregnancy test) * active infectious systemic disease * active infectious ocular or extraocular disease * obstructed nasolacrimal duct in the study eye (s) * hypersensitivity to dexamethasone or prednisolone eye drops * patients being treated with immunomodulating agents in the study eye(s) * patient being treated with immunosuppressants and/or oral steroids * patients with severe disease that warrants critical attention, deemed unsafe for the study by the investigator
a study of anti-pd-1/ctla-4 bispecific ak104 plus lenvatinib in first-line advanced hepatocellular carcinoma

Conditions: Hepatocellular Carcinoma

Summary: an open-label multi-center phase ib/ii study to evaluate the efficacy and safety of anti-pd-1/ctla-4 bispecific antibody ak104 plus lenvatinib as the first-line therapy for patients with advanced hepatocellular carcinoma.

this is a multi-center, multi-cohort, open-label phase 1b/2 clinical study to evaluate the anti-tumor activity, safety, pk profile, immunogenicity and potential biomarkers of ak104 plus lenvatinib for the treatment of advanced hepatocellular carcinoma.

Eligibility criteria:
inclusion criteria: * signed written informed consent form voluntarily. * histologically or cytologically documented hepatocellular carcinoma. * bclc stage c, and non-resectable bclc stage b . * at least one measurable lesion according to recist criteria. * ecog of 0 or 1. * adequate organ function. * estimated life expectancy of ≥3 months. * for women of childbearing potential: agreement to remain abstinent; for men: agreement to remain abstinent. exclusion criteria: * histologically or cytologically documented fibrolamellar hepatocellular carcinoma, sarcoma-like hepatocellular carcinoma, cholangiocarcinoma, etc. * history of hepatic encephalopathy or liver transplantation. * clinical significance of hydrothorax, ascites or pericardial effusion. * central nervous system metastases and/or carcinomatous meningitis. * any risk of bleeding; severe bleeding tendency or coagulation dysfunction, or under thrombolytic therapy. * occurred arteriovenous thromboembolic events within 6 months before the first administration. * tumor volume \> 50% liver volume; portal vein tumor thrombus or inferior vena cava tumor thrombus. * inadequately controlled arterial hypertension. * attack of symptomatic congestive heart failure (lvef\<50%); history of congenital long qt syndrome. * known presence or history of interstitial lung disease or required hormone treatment interstitial lung disease. * severe infections. * receipt of any anti-tumor treatment, chemotherapy, targeted therapy, immunotherapy, * enrollment of another clinical study within 4 weeks prior to the first administration of study drugs. * unable to receive an enhanced ct or mri scan of the liver.

Keywords: vegf anti-pd-1 tyrosine kinase inhibitor (tki) anti-ctla-4
intravenous dexmedetomidine in cesarean section under spinal anesthesia

Conditions: Cesarean Section Complications

Summary: the present study hypothesized that intravenous dexmedetomidine use during spinal anesthesia for cesarean section has a beneficial influence on hemodynamic stability and epigastric pain together with satisfactory analgesic effects and excellent safety profile for the mother and the newborn.

background and aim: hypotension and epigastric pain are commonly encountered during spinal anesthesia for cesarean section. dexmedetomidine (dex) is a highly selective α 2-adrenergic agonist. its effects entail sympatholytic, sedative, anesthetic, and analgesic actions. the present randomized study aimed to evaluate the effect of intravenous dex administration on the hemodynamic parameters and epigastric pain in women subjected to cesarean section. patients and methods: this study is a randomized double-blinded controlled trial. seventy patients were randomly assigned to one of two interventional groups: one group received spinal anesthesia and intravenous dex (1µg/kg) and the other group received spinal anesthesia and placebo (saline). the administrated drugs were slowly injected intravenously over 10 minutes then intrathecal block was achieved using 2-2.2 ml of hyperbaric bupivacaine (10 -12.5 mg) introduced at l3/4 or l4/5 interspace. primary outcome parameters included frequency of hypotension episodes, frequency of ephedrine doses needed, sedation score and epigastric pain episodes. secondary outcomes included time to onset of sensory and motor blocks, duration of sensory and motor blocks, operative duration, time needed to request of rescue analgesia, level of intrathecal block, and neonatal apgar score at 1 and 5 minutes.

Eligibility criteria:
inclusion criteria: * full-term pregnancy and american society of anesthesiologists (asa) physical status i/ii in women scheduled for elective cesarean section exclusion criteria: * severe hepatic or renal disease * severe cardiopulmonary disease * thyroid disorders multiple allergies prematurity * known fatal abnormality * known chronic gastrointestinal problems with epigastric pain e.g. peptic ulcer and reflux esophagitis.

Keywords: dexmedetomidine spinal anesthesia cesarean section epigastric pain