Kornimate/medical-research-clean huggingface dataset:
clinical study of b001 injection in subjects with neuromyelitis optic spectrum disorder (nmosd)

Conditions: NMO Spectrum Disorder

Summary: the objectives of this phase ib study are to evaluate the efficacy, safety, pharmacokinetics, pharmacodynamics and immunogenic profiles of b001 in subjects with aquaporin-4 antibody (aqp4-igg) positive nmosd.


Eligibility criteria:
inclusion criteria: 1. nmosd as defined by either of the following 2015 criteria with anti-aqp4 antibody (ab) seropositive status at screening 2. clinical evidence of at least 1 documented relapse in last 12 months prior to screening 3. expanded disability status scale (edss) score from 0 to 7.5 inclusive at screening 4. age 18 to 70 years, inclusive at the time of informed consent exclusion criteria: 1. any previous treatment with anti-cd20, eculizumab, anti-blys monoclonal antibody (e.g., belimumab), any other treatment for prevention of multiple sclerosis (ms) relapse (e.g., interferon, natalizumab, glatiramer acetate, fingolimod, teriflunomide or dimethyl fumarate) within 6 months prior to baseline. 2. received immunosuppression such as azathioprine, mycophenolate mofetil, methotrexate, cyclophosphamide, tacrolimus, mitoxantrone, cyclosporine a, etc, and rug therapy, biological agents such as satralizumab, tocilizumab, eculizumab, etc, 3 months prior to the first administration. 3. evidence of serious uncontrolled concomitant diseases that may preclude participant participation, as described; other nervous system disease, cardiovascular disease, hematologic/hematopoiesis disease, respiratory disease, muscular disease, endocrine disease, renal/urologic disease, digestive system disease, congenital or acquired severe immunodeficiency. 4. known active infection within 3 months prior to baseline 5. pregnancy or lactation. 6. history of severe allergic reaction to a biologic agent 7. evidence of chronic active hepatitis b or c 8. evidence of active tuberculosis 9. following laboratory abnormalities at screening\*: 1. white blood cells (wbc) \<4.0 x10\^3/microliter (μl) 2. absolute neutrophil count (anc) 3. absolute lymphocyte count \<0.5 x10\^3/μl 4. platelet count \<80 x 10\^9/ l 5. aspartate aminotransferase (ast) or alanine aminotransferase 10. history of drug or alcohol abuse within 6 months prior to baseline 11. receipt of any live or live attenuated vaccine within 4 weeks prior to baseline 12. uncontrolled systemic diseases, including hypertension that cannot be effectively controlled after treatment (systolic blood pressure ≥150 mmhg and/or diastolic blood pressure ≥100 mmhg), diabetes, gastrointestinal diseases, etc.; or the investigator believes that there is anything inappropriate reasons for selection.
effect of posterior corneal toricity on refractive outcome of pseudophakia

Conditions: Astigmatism; Cataract

Summary: this study is to evaluate the necessity of considering posterior corneal toricity on refractive outcome of patients with cataracts and corneal astigmatism after implantation of intraocular lenses. this is determined by comparing total corneal and refractive astigmatism,and by comparing the expected refractive result with actual refractive astigmatism postoperatively,using total corneal and anterior corneal astigmatism to calculate respectively.


Eligibility criteria:
inclusion criteria: * cataract candidates * preoperative corneal regular astigmatism \>0.75d * willing and able to complete all required postoperative visits * able to comprehend and sign a statement of informed consent exclusion criteria: * significant intraocular lenses tilt or decentration * corneal scarring * irregular corneal astigmatism * other ocular diseases * surgical complication

Keywords: astigmatism pseudophakia
a study of ly2584702 in solid tumors

Conditions: Cancer

Summary: the purpose of this study is to assess the safety and tolerability of ly2584702 in japanese patients with advanced and/or metastatic solid tumors for which no proven effective therapy exists.


Eligibility criteria:
inclusion criteria: * have histological or cytological evidence of a diagnosis of advanced and/or metastatic cancer (solid tumors) that is refractory to standard therapy and/or therapies known to provide clinical benefit, or for which no standard therapy exists. * have the presence of disease amenable to efficacy assessment as defined by the response evaluation criteria in solid tumors (recist). japanese patients who have advanced non-measurable disease with elevation of a validated tumor marker may be eligible, if discussed and agreed upon by the investigator and lilly. * have adequate organ function including: * hematologic: absolute neutrophil count (anc) greater than or equal to 1.5 x 10\^9/liter (l), platelets greater than or equal to 100 x 10\^9/l, and hemoglobin greater than or equal to 9 gram/deciliter (g/dl) (transfusions are not allowed prior to enrollment within 2 weeks). * hepatic: bilirubin less than or equal to 1.5 times upper limit of normal (uln), alkaline phosphatase (alp), alanine transaminase (alt) and aspartate transaminase (ast) less than or equal to 2.5 times uln, or 5 times uln for patients with hepatic metastases. patients with bone metastases may enter with alkaline phosphatase values less than 5 times uln, as long as other hepatic parameters meet inclusion criteria. * renal: serum creatinine less than or equal to 1.5 times uln. * have a performance status of less than or equal to 2 on the eastern cooperative oncology group scale * have discontinued all previous therapies for cancer, including chemotherapy, radiotherapy, cancer-related hormonal therapy prior to study enrollment and recovered from the acute effects of therapy. * have an estimated life expectancy of 12 weeks or greater * are able to swallow capsules exclusion criteria: * have received treatment within 4 weeks of the initial dose of study drug with a drug that has not received regulatory approval for any indication. * have serious preexisting medical conditions or serious concomitant systemic disorders that, in the opinion of the investigator, would preclude participation in this study. * prior clinical history of tuberculosis (patient doubt tuberculosis is screening required), and positive test results in hepatitis b surface antigen (hbsag), or hepatitis c antibodies (hcab) (screening required). * have symptomatic central nervous system (cns) malignancy or metastasis. patients with treated cns metastases are eligible provided their disease is radiographically stable, asymptomatic, and they are not currently receiving corticosteroids and/or anticonvulsants. screening of asymptomatic patients without history of cns metastasis is not required. * have hematologic malignancies, or lymphoma.

Keywords: advanced cancer metastatic cancer p70s6 inhibitor
muscle in acromegaly and cushing's syndrome

Conditions: Cushing Syndrome; Acromegaly

Summary: cushing's syndrome (cs) and acromegaly determine myopathy and muscle weakness which persist long-term after control of hormone excess. fatty infiltration in skeletal muscle (myosteatosis) is associated with muscle atrophy, frailty, and increased morbidity and mortality in several human models. the study is aimed at evaluating muscle structure in patients with controlled cs and acromegaly, and correlate it with functional tests of muscle strength. in addition, circulating molecules potentially mediating persistent myopathy in these patients will also be assessed.

prior chronic exposure to glucocorticoids or growth hormone (gh) determines fat infiltration and persistent impairment of muscle structure in "cured" patients with cs or acromegaly, respectively. all this leads to irreversible changes in muscle strength and performance, markedly affecting morbidity and quality of life of these patients. in particular, muscle weakness would contribute significantly to the development of severe arthropathy associated with excess gh, as well as deterioration of bone status and increased risk of fracture, as described in patients with either cs or acromegaly in remission. our aim is to evaluate whether muscular mri is a useful tool for the assessment of myopathy and myosteatosis in these patients. if this is the case, we would have identified a non-invasive test that would allow the follow-up of patients at risk of developing functional motor problems, anticipating the onset of muscle weakness or fatigue and consequent deterioration of their quality of life. on the other hand, we will examine the role of micrornas, which can suppress the process of myogenic differentiation, as potential modulators of myopathy in these conditions. indeed, micrornas could be used in clinical practice as markers to identify patients at risk of myopathy, and develop strategies for their prevention. clarifying the impact of muscle fat infiltration on muscle strength would allow us to better understand the interaction between muscle and adipose tissue, encouraging research on potential mediators of this relationship, such as myostatin (mstn) (able to direct the mesenchymal cell muscle towards the formation of adipocytes at the expense of myocytes) and adiponectin (apn) (which keeps the levels of fat in the muscle low while favoring the formation and regeneration of muscle tissue).

Eligibility criteria:
inclusion criteria: * patients with cushing's syndrome or acromegaly who have been in remission for at least 5 years. exclusion criteria: * pregnancy, breastfeeding, chronic liver/kidney disease, chronic treatment with glucocorticoids.

Keywords: muscle weakness myopathy
a study of the pharmacokinetics and safety of single-dose inhaled icf004 in healthy volunteers and patients with interstitial lung disease

Conditions: Interstitial Lung Disease (ILD); Healthy Volunteers

Summary: this phase 1 clinical trial investigates the pharmacokinetics and safety profile of single-dose inhaled icf004, an epigallocatechin gallate (egcg) powder formulation, in healthy volunteers and patients with interstitial lung disease (ild). the randomized, double-blind, dose-escalation study employs a parallel-group design with three inhaled dose cohorts (4mg, 8mg, and 12mg) and one oral comparator arm (600mg teavigo®), enrolling a total of 42 patients (12 per inhaled group, 6 in oral group) and 42 healthy volunteers (12 per inhaled group, 6 in oral group). the trial features comprehensive pharmacokinetic sampling through 15 timed blood collections over 24 hours and bronchoalveolar lavage at specified intervals (1h, 6h, 12h, or 24h post-dose) to characterize both systemic and pulmonary drug exposure. the study incorporates rigorous safety monitoring including adverse event tracking, vital sign measurements, and laboratory assessments over a 7-day observation period following drug administration. conducted at shanghai jiao tong university's ruijin hospital over a 12-month period (july 2025-july 2026), this investigation aims to establish the foundational pharmacokinetic parameters and safety profile of inhaled egcg delivery in ild patients while comparing pulmonary bioavailability against conventional oral administration.


Eligibility criteria:
icd patients: inclusion criteria: 1. age ≥40 years, any gender 2. diagnosed or suspected ild (ipf or ctd-ild) based on hrct or thin-section ct 3. fvc ≥40% predicted, dlco ≥40% predicted, fev1/fvc ≥0.7 4. able to tolerate bronchoscopy 5. willing to use effective contraception during study 6. able to abstain from coffee/tea products 48h before to 48h after dosing 7. capable of proper inhaler use exclusion criteria: 1. pregnancy or lactation 2. allergy to study drug components 3. active respiratory infection or acute cardiopulmonary disease 4. abnormal liver function (alt/ast/ggt \> uln or total bilirubin \> uln) 5. recent smoking (within 6 months) or alcohol abuse 6. participation in other clinical trials within 3 months 7. blood donation ≥400ml within 3 months 8. hbv dna ≥2000 iu/ml or hcv rna ≥1000 iu/ml or hiv positive
bilateral dual transversus abdominis plane block for robotic assisted laparoscopic surgery

Conditions: Pain Treatment; Robotic Assisted Laparoscopic Surgery; Bilateral Dual Transversus Abdominis Plane Block

Summary: to evaluate the effects of bilateral dual transversus abdominis plane block on postoperative pain after robotic assited laparoskopic surgery and measure the plasma-level of ropivacain after the bilateral dual transversus abdominis plane block.

after randomisation patients for robotic assisted laparoscopic surgery will receive bilateral dual transversus abdominis plane block containing either ropivacain or isotonic potassium chloride. the investigators will record pain-score, opioid-consumption and sensibility on the abdominal wall in the postoperative periode. also a blood sample will be taken at 15, 30, 60, 120 and 240 minutes after the block in order to measure the plasma-level of ropivacain after bilateral dual transversus abdominis plane block. the investigators assume that there will be significant effect on postoperative pain and that the level of plasma-ropivacain will be acceptable.

Eligibility criteria:
inclusion criteria: * patients scheduled for robotic assisted laparoscopis surgery * acceptance to participate exclusion criteria: * allergies to local analgetics * daily use of strong opioids

Keywords: postoperative pain opioid consumption termanalgesia plasmaropivacain level
the performance of multi-tracer multimodality pet in lymphoma

Conditions: Positron-Emission Tomography

Summary: investigating the performance of multi-tracer multimodality pet in lymphoma

in this study investigators evaluated nodal and extranodal lymphoma lesions uptake by different molecular probe such as fdg, fapi-04 via multimodality pet (pet/ct and pet/mr). our previous studies have shown that uptake of fapi-04 on pet may be an indicator of lymphoma lesions. the combination of pet with ct/mr allows for depicting metabolic, functional and morphological properties of tumor lesions at the same time, which is therefore an alternative attractive pairing for diagnosis, staging and prognosis of lymphoma.

Eligibility criteria:
inclusion criteria: * pathologically diagnosed as lymphoma; * written informed consent for receiving fapi-04 pet examinations. * cancer planned chemotherapy or immunotherapy scheme. * expected survival ≥ 12 weeks exclusion criteria: * cannot lie supine for half an hour; * refuse to join the clinical researcher; * severe liver or kidney dysfunction * pregnancy or lactation

Keywords: positron-emission tomography lymphoma
major activation of ncc in graft urinary exosomes

Conditions: Kidney Transplantation

Summary: hypertension is common disorder after renal transplantation and is associated with mortality. calcineurin inhibitor (cni), by activating ncc cotransporter, may be a major determinant of hypertension, included in a "gordon like" syndrome. however, prevalence of ncc activation by cni is unknown. our objective is to determine the prevalence of ncc activation three months after transplantation in patient treated by cni.

hypertension is common disorder after renal transplantation and is associated with mortality. calcineurin inhibitor (cni), by activating ncc cotransporter, may be a major determinant of hypertension, included in a "gordon like" syndrome. gordon syndrome is a rare genetic disorder where ncc cotransporter is overactivated and cause hypertension, metabolic acidosis and tendency to hyperkaliemia. few studies evaluated ncc expression by exosomes techniques in human kidney transplant, and mostly compared ncc expression in specific subpopulation (for example with or without hypertension). thus, prevalence of ncc activation by cni is unknown. to determine it, we will include prospective patients in bordeaux and la réunion who undergo urine and blood tests three months after transplantation, and a control group with no transplantation and no use of cni. first, we will compare kidney recipients and control and use immunoblot to quantify ncc expression in urinary exosomes to identify the population of transplanted with a high activation. then, we will analyze the relationship between ncc activation and clinicobiological features of gordon's syndrome.

Eligibility criteria:
for kidney transplant group : * inclusion criteria: * age≥18years * recipients three months after kidney transplantation using calcineurin inhibitors * glomerular filtration rate\>15ml.mn.m2 ckd-epi * renal ultrasound underwent before inclusion * no opposition at participating at the research * exclusion criteria: * use of diuretic thiazides or aldosterone receptor antagonists in the month preceding inclusion * graft artery stenosis with indication of interventional radiology or surgery for control group : * inclusion criteria * no previous transplantation * age≥18years * no hypertension * no metabolic disorders (dysnatremia, dyskaliemia, acidosis or alkalosis) * no opposition at participating at the research * exclusion criteria: * use of diuretic thiazides or aldosterone receptor antagonists in the month preceding inclusion

Keywords: calcineurin inhibitors hypertension kidney transplant acidosis gordon syndrome
smoking relapse-prevention intervention for cancer patients

Conditions: Smoking Cessation

Summary: the purpose of this study is to test different ways to help cancer patients maintain their smoking abstinence. participants may receive educational materials as part of the study.

this study involves participation at four distinct time points over a one-year period. * baseline assessment * 2-month follow-up telephone call * 6-month follow-up telephone call * 12-month follow-up telephone call

Eligibility criteria:
inclusion criteria: * have smoked at least 10 cigarettes per day for at least one year prior to cancer diagnosis * able to read and write english * able to give informed consent * have quit smoking after receiving their cancer diagnosis * have not quit greater than 3 months prior exclusion criteria: * individuals who have been abstinent for greater than 3 months are not included because they are less likely to relapse. a quit will be defined as self-reported no smoking for 24 hours. individuals with metastatic disease will be excluded because participation in the study might be burdensome.

Keywords: relapse prevention smoking habit forever free
sequential treatment of hepatocellular carcinoma by transarterial chemoembolization and local ablation or external radiation

Conditions: Hepatocellular Carcinoma

Summary: hepatocellular carcinoma (hcc) can present itself in many forms (size, number of lesions) for the treatment of which a therapeutic panel can be elaborated and layered. if a curative treatment cannot be considered in case of an hcc classified in an intermediate stage, a transcatheter arterial chemoembolization (tace) can be proposed. in case of a partial response or the treatment of some lesions of a multifocal hcc, a combined treatment by stereotaxic radiotherapy (ck), radiofrequency ablation (rfa) or microwave ablation (mwa) may be initiated in accordance with a decision of the multidisciplinary consultation meeting. the aim of this study was to evaluate the clinical outcome of hcc receiving mwa, rfa or ck after downstaging with tace.


Eligibility criteria:
inclusion criteria: * a hcc treated by tace followed by rfa, mwa and/or ck * from 01/2010 to 12/2020 * treated by nancy regional university hospital (tace, rfa, mwa) and institut de cancérologie de lorraine (ck) exclusion criteria: * combined treatment over one year following the last tace * no baseline, in between or after combined treatment imaging * lesion appeared after tace treatment

Keywords: hepatocellular carcinoma transarterial chemoembolization stereotactic body radiotherapy radiofrequency ablation microwave ablation
uncomplicated nausea and vomiting in the emergency department

Conditions: Nausea; Vomiting

Summary: nausea and vomiting is a common complaint in the emergency department. treatment is important for many reasons. in addition to patient comfort, there are adverse effects secondary to vomiting such as dehydration, metabolic alkalosis, mallory-weiss tears, and aspiration. two mediations common used for nausea in ed patients include ondanesetron and metoclopramide.

this study will compare ondansetron 4 mg vs 2 mg vs metoclopramide 10 mg to look for efficacy in nausea and vomiting treatment for patients in the ed with many different causes. we will also look for cost effectiveness as well, since metoclopramide is much less expensive than ondansetron, which is less expensive at lower doses. there is little research about nausea medication in the ed literature even though these medications are used frequently in the ed for many causes of nausea.

Eligibility criteria:
inclusion criteria: * 18 years or older with nausea and at least 1 episode vomiting in the last 12 hours presenting to the york hospital emergency department exclusion criteria: * patients known to have hypersensitivity to the drugs ondansetron or metoclopramide * gastrointestinal hemorrhage, mechanical obstruction or perforation * patients with pheochromocytoma * seizure disorder * patients receiving other drugs which are likely to cause extrapyramidal reactions such as butapherones and phenothiazines * patients experiencing hyperemesis gravidum * patients unable to understand the informed consent (intoxicated, spanish speaking) * prior antiemetics within 12 hours * inability to perform visual analog scale * renal dialysis

Keywords: nausea vomiting ondansetron metoclopramide randomized double-blind nausea and vomiting in the emergency department
safety and tolerability of repeat dosing of gsk233705/gw642444 in copd

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: the purpose of this study is the evaluate the safety and tolerability of repeat dosing of the combination of inhaled gsk233705 and gw642444 administered once-daily in subjects with copd.


Eligibility criteria:
inclusion criteria: * male and females 40 to 80 years of age (inclusive) * copd diagnosis * current or previous smokers with a cigarette smoking history of at least 10 pack- * post-albuterol fev1/fvc of 0.70 or less * post-albuterol fev1 of 35% to 80% (inclusive) exclusion criteria: * pregnant or lactating females * current diagnosis of asthma * respiratory disorders other than copd * clinically significant cardiovascular, neurological, psychiatric, renal, immunological, endocrine, or hematological abnormalities that are uncontrolled * clinically significant sleep apnea * previous lung resection surgery * clinically significant abnormalities confirmed by chest x-ray that are not related to copd * hospitalization for copd within 3 months of screening * use of antibiotics for lower respiratory tract infection within 6 months of screening * abnormal and clinically significant 12-lead ecg findings * current malignancy in remission for less that 5 years * medical conditions that would contraindicate the use of anticholinergics * positive hepatitis b or c test * history of alcohol or drug abuse * unable to withhold albuterol for 6 or more hours * use of long term oxygen therapy * conditions that would limit the validity of informed consent * use of gw642444 or gsk233705 in previous studies * use of an investigation drug with 30 days of screening * use of inhaled corticosteroids (ics) at a dose greater than 1000mcg of fluticasone propionate or equivalent * hypersensitivity to beta-agonists * concurrent use of long-acting beta-agonists (laba) or long-acting muscaring antagonists, laba/ics combination products, cytochrome p450 inhibitors, oral or depot corticosteroids, theophyllines, oral beta agonists, oral leukotrine modulators, inhaled short acting anticholinergics.

Keywords: copd long-acting beta agonist emphysema chronic bronchitis chronic obstructive pulmonary disease (copd) bronchodilator long acting muscarinic antagonist