Kornimate/medical-research-clean huggingface dataset:
rmp-a03 ocular suspension in patients with pterygium

Conditions: Pterygium

Summary: the goal of this clinical trial is to test the safety and efficacy of an ocular medication on the treatment of pterygium.

following informed consent, patients with pterygium who meet all eligibility criteria will be randomized to an 84-day double-blinded study to measure the safety and efficacy of the study drug as compared to placebo.

Eligibility criteria:
inclusion criteria: * must be at least 18 years old * diagnosis of pterygium with specified characteristics * bcva of 20/200 or better * willingness to attend all study visits and comply with the study procedures exclusion criteria: * presence of ocular disease * double pterygium * history of ocular surgery * presence of ocular trauma * use of any ocular medication * use of contact lens * allergy to any of the components of study drug * cannot properly administer study drug * clinically significant systemic disease that may place the subject at risk or confound study results * participation in an investigational study within 30 days prior to screening * female participants who are pregnant, nursing, planning a pregnancy, or not using a medically acceptable form of birth control (wocbp).
autonomic reflexes during intra-arterial chemotherapy for retinoblastoma

Conditions: Retinoblastoma; Retinoblastoma Bilateral; Chemotherapy Effect

Summary: prospective observational study in patients undergoing intra-arterial ophthalmic artery chemotherapy for the treatment of retinoblastoma. the main objective of the study is to evaluate the incidence of cardiorespiratory autonomic reflexes in these patients and to investigate the association between autonomic reflexes and perioperative clinical characteristics.


Eligibility criteria:
inclusion criteria: * all patients diagnosed with retinoblastoma and submitted to intra-arterial chemotherapy during the study period * informed consent form signed and dated by legal guardian and investigator * informed assent form signed by the patient if appropriate exclusion criteria: * refusal of the patient or guardian to participate in the research project

Keywords: retinoblastoma
diesel exhaust and mechanism of asthma

Conditions: Asthma

Summary: this experiment is designed to test the hypothesis that oxidative stress is responsible for changes in airway responsiveness in humans exposed to diesel exhaust.

the specific aim is to test the hypothesis that diesel exhaust (de) increases airway reactivity via oxidative stress, particularly in asthmatics. to test this hypothesis, we use a crossover in vivo experimental model in mild asthmatics and normal controls using a state-of-the-art diesel exhaust exposure facility. participants took n-acetylcysteine (600 mg) or placebo capsules three times daily for six days. on the final morning of supplementation, participants were exposed for 2 hours to either filtered air or diesel exhaust (300 µg·m-3 of particulate matter smaller than 2.5 microns). twenty-six non-smokers between 19-49 years were studied under three experimental conditions (filtered air with placebo, diesel exhaust with placebo and diesel exhaust with n-acetylcysteine) using randomized, double-blind, crossover design, with a two week minimum washout between conditions. methacholine challenge was performed pre-exposure (to determine baseline airway responsiveness) and post-exposure (to determine the effect of exposure).

Eligibility criteria:
inclusion criteria: * between 19-49 years, non smokers, asthmatics, healthy controls exclusion criteria: * smokers, pregnant or co-existing medical condition for which diesel exhaust would confer significant risk (i.e. coronary artery disease)

Keywords: air pollution diesel exhaust airway responsiveness asthma anti-oxidant
a study of mg7 redirected autologous t cells for advanced mg7 positive liver metastases(mg7-cart)

Conditions: Liver Metastases

Summary: the purpose of this study is to collect the data on the safety and potential effectiveness of intra-tumor injection of mg7-cart cells under ultrasound guidance in patients with liver metastases expressing mg7 positively.

designer t cells are prepared by pbmc which from patients by leukapheresis, and then activated and re-engineered to express chimeric antigen receptors (cars) specific for mg7, which is a glycosylated protein of cea. cells are expanded in culture and returned to the participant by intra-tumor injection at the dose of (1-6)×108 car positive t cells. the cells perfusion process would last for 1min to 2min. the dose of 1.5 grams/m2 of cyclophosphamide will be given two days before cart cell infusion.

Eligibility criteria:
inclusion criteria: * mg7 expression positive by histologically confirmed; * aged between 18 and 69; * persistent cancer after at least one prior standard of care chemotherapy, has no willing for surgery or cannot be suitable for surgery patients; * tumor is too big to surgical resection; * life expectancy greater than 4 months; * satisfactory organ and bone marrow function as defined by the following: (1) creatinine \ 55%; (3) hemoglobin\>9g/dl, bilirubin 2.0×the institution normal upper limit; * without bleeding disorder or coagulation disorders; * dont allergy to radiocontrast agent; * birth control; * adequate venous access for apheresis, and no other contraindications for leukapheresis; * voluntary informed consent is given. exclusion criteria: * pregnant or lactating women; * concurrent use of systemic steroids. recent or current use of inhaled steroids is not exclusionary; * patients in the situation of: (1) 30 days before apheresis is still in the period of other antitumor drug observation; (2) patient dont recuperate from earlier acute adverse influence brought by any treatments accepted before; * four weeks before recruit accepted radiation therapy; * previously treatment with any gene therapy products; * feasibility assessment during screening demonstrates\<30% transduction of target lymphocytes, or insufficient expansion (\<5-fold) in response to cd3/cd28 costimulation; * any serious, uncontrolled diseases (including, but not limit to, unstable angina pectoris, congestive heart failure, grade iii or iv cardiac disease, serious arrhythmia, liver and kidney disorders or metabolic diseases, cns diseases); * patient with severe acute hypersensitive reaction; * taking part in other clinical trials; * study leader considers not suitable for this tiral.
continuous versus demand-based oxygen in patients with fibrotic interstitial lung disease and chronic obstructive pulmonary disease

Conditions: Interstitial Lung Disease; Chronic Obstructive Pulmonary Disease

Summary: the goal of this randomised clinical trial is to compare the efficacy of exertional oxygen delivery by continous versus demand-based flow systems in patients with fibrotic interstitial lung disease and chronic obstructive pulmonary disease . the main questions it aim to answer: is there a difference in lowest oxygen saturation? is there a difference in saturation: time below \<90%, pulse rate, distance and patient preferences ? it is a cross over study, so all patients will test both methods. participants will perform 2 6-minute walk tests with the two different oxygen delivery systems.

the study design is a single center, randomized, open-label cross-over exploratory comparative study to investigate the efficacy of two different oxygen delivery systems. patients with chronic obstructive pulmonary disease or fibrotic interstitial lung disease that during a six-minute walk test can walk at least 50 m and desaturate below 88%, can be included in the study. the participants are performing 2 6-minute walk tests, randomized to perform the test with oxygen bottles or portable concentrators first. primary endpoint is the difference in the lowest oxygen saturation between the two systems. secondary endpoints are amongst others: difference in percentage of time and number of minutes when oxygen falls below 90%, mean and maximum pulse rate, distance and time taken to recover during the 6-minute walk test and scores from questionnaires. after 3-6 months, semistructured interviews will be done to record participants' experiences of ambulatory oxygen therapy.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * verified diagnosis of fibrotic interstitial lung disease or chronic obstructive pulmonary disease * desaturation \< 88% during 6-minute walk test or currently receiving ambulatory oxygen by continous oxygen * able to walk at least 50 meters during a 6-minute walk test * self-reported stable respiratory symptoms in the previous 2 weeks * cognitively able to understand and participate in the study * written informed consent exclusion criteria: * any physical condition including paralysis, lower extremity pain, or other musculoskeletal problems limiting exercise performance * unstable heart condition or symptomatic stenotic valve disease * smoking during the previous 24 hours * pregnant women * anemia, hb \< 7.3 mmol/l (women) or \< 8.3 mmol/l (men) * non-invasive ventilation

Keywords: interstitial lung disease chronic obstructive pulmonary disease oxygen therapy palliation
safety and efficacy of exe844 otic suspension in otitis media at time of tympanostomy tube insertion (omtt) - study 2

Conditions: Otitis Media With Effusion in Children; Otitis Media Recurrent

Summary: the purpose of this study is to evaluate exe844 plus tympanostomy tubes compared to tympanostomy tubes only based on sustained clinical cure at end-of-therapy (eot).


Eligibility criteria:
inclusion criteria: * recurrent acute otitis media (raom) or chronic otitis media with effusion (come) and eligible for bilateral myringotomy and tympanostomy tube insertion. * suspected bacterial infection at time of surgery in at least 1 ear. * willing to refrain from water immersion of the ears following surgery without the use of adequate ear protection during swimming, bathing, showering and other water-related activities. * legally authorized representative (lar) must read and sign the informed consent. * parent or caregiver must agree to comply with the requirements of the study and administer study medication as directed, complete required study visits, and comply with the protocol. * other protocol-specified inclusion criteria may apply. exclusion criteria: * previous otologic or otologic-related surgery within the past 30 days or ongoing complications. * middle ear pathology in either ear other than otitis media. * current acute otitis externa (aoe), malignant otitis externa (moe) or other conditions which could interfere with evaluation of the study drug. * any systemic disease or disorder, complicating factor or structural abnormality that would negatively affect the conduct or outcome of the study based upon assessment by the investigator. * known or suspected allergy or hypersensitivity to quinolones or other active or inactive ingredients present in the medications to be used in the study. * other protocol-specified exclusion criteria may apply.
tifact study - tissue factor expression by adipose tissue in extremely obese subjects.

Conditions: Obesity

Summary: tissue factor is the main activator of coagulation cascades. excessive tissue factor expression is made responsible of thrombosis in a number of clinical situations including thrombosis in contact with atherosclerotic plaques. recent work showed that tissue factor gene expression in adipose tissue was significantly increased in obese versus lean mice. the main objective of this study is to show that tissue factor expression is increased in human adipose tissue obtained from obese subjects and to identify its main tissular origin by comparing abdominal and subcutaneous adipose tissue. the secondary objectives are to identify the cell origin of tissue factor (adipocytes versus stromal cells) and to analyze the relation ship between blood tissue factor and (i) tissue factor expressed by adipose tissue, (ii) the amount of subcutaneous and profound adipose tissue, and (iii) coagulation activation markers.

tissue factor is the main activator of coagulation cascades. excessive tissue factor expression is made responsible of thrombosis in a number of clinical situations including thrombosis in contact with atherosclerotic plaques. recent work showed that tissue factor gene expression in adipose tissue was significantly increased in obese versus lean mice. the main objective of this study is to show that tissue factor expression is increased in human adipose tissue obtained from obese subjects and to identify its main tissular origin by comparing abdominal and subcutaneous adipose tissue. the secondary objectives are to identify the cell origin of tissue factor (adipocytes versus stromal cells) and to analyze the relation ship between blood tissue factor and (i) tissue factor expressed by adipose tissue,

Eligibility criteria:
inclusion criteria: * bmi \> 35 * stable obesity * abdominal or pelvic surgery * agree to participate to the study exclusion criteria: * malignancy, * infectious or inflammatory disease, notably hiv infection * pregnancy * history of ischemic cardio or neurovascular event, lower limb arteritis

Keywords: tissue factor obesity adipose tissue microparticles
herombopag + rhtpo in severe immune thrombocytopenia

Conditions: Immune Thrombocytopenia

Summary: severe immune thrombocytopenia (itp) is a life-threatening acquired hemorrhagic disease with dramatically decreased platelet number and clinical bleeding symptoms. some patients with severe itp did not respond to first-line treatment including steroids and ivig. it was critical for them to use effective treatments to promote platelet and reduce the risk of fatal bleeding. in this study, the patients with severe itp will be treated with hetrombopag, rhtpo, and the combination of hetrombopag and rhtpo, respectively. the effect evaluation includes the increase of platelet number and decrease of bleeding scores. changes of coagulation, platelet activation, fribrinolysis influence, and thrombotic events will also be accessed for the safety of treatments. the aim of this study is to demonstrate that the combination of hetrombopag and rhtpo for severe itp is more effective than the other two monotherapy and does not increase thrombotic events or thrombosis risk.

patients with severe itp will be randomly assigned to three groups: rhtpo group, herombopag group, herombopag combined with rhtpo group. the effective rate of treatment, the rate and amplitude of platelet increase, the response time of platelet maintenance, and the effect of combination therapy on hemostasis will be compared. at the same time, the investigators will analyze the markers of thrombosis and thrombotic events to assess the safety of combination therapy.

Eligibility criteria:
inclusion criteria: 1. male or female,70 ≥age≥18； 2. diagnosed as primary immune thrombocytopenia； 3. platelet count was less than 10 × 10e9 / l with active bleeding, or bleeding score ≥ 5 points； 4. no use of ivig, avatrombopag, eltrombopag or romiplostim 2 weeks before treatment； 5. rituximab was used for at least 2 months, and other immunosuppressants were stable for at least 4 weeks. 6. there was no history of platelet transfusion one week before treatment. exclusion criteria: 1. secondary thrombocytopenia caused by other autoimmune diseases and virus infection was excluded； 2. patients with active malignant tumors, pregnancy, severe cardiovascular， cerebrovascular diseases and a history of arteriovenous thrombotic diseases were excluded； 3. patients deemed unsuitable for enrollment by the investigator； 4. patients with thrombotic disease or serious uncontrolled cardiovascular and cerebrovascular disease; 5. patients reject to participate in the study.

Keywords: immune thrombocytopenia severe herombopag recombinant human thrombopoietin
cardiotoxicity profile of abiraterone in prostate cancer : a pharmacovigilance study

Conditions: Arrhythmias, Cardiac; Atrial Fibrillation and Flutter; Tachycardia, Supraventricular; Cardiac Failure

Summary: abiraterone associated with prednisone is used in prostate cancer. abiraterone is a selective small-molecule inhibiting cytochrome p450 17a1 (cyp17a1), a key enzyme in androgen synthesis. cyp17a inhibition is also responsible for mineral corticosteroid related adverse events as hypokaliemia, fluid retention, and hypertension. primary hyperaldosteronism is associated with cardiovascular toxicities such as atrial fibrillation and cardiac failure. other androgen-deprivation therapies are not associated with increased mineral corticosteroid level. this study investigates reports of cardiovascular toxicities for treatment including l02 (sex hormones used in treatment of neoplastic diseases), and g03 (sex hormones) used in prostate cancer in the french pharmacovigilance database and in the eudract database.

due to its peculiar pharmacology, abiraterone is potentially associated with more cardiotoxicity as compared to other androgen-deprivation therapies. this study investigates the main characteristics of patients affected by cardiovascular side effects of which supraventricular arrhythmias (including atrial fibrillation, atrial flutter, supraventricular tachycardia), and cardiac failure imputed to drugs classified as l02, and g03 according to anatomical therapeutic chemical (atc) classification. a causality assessment according to the world health organization-the uppsala monitoring centre (who-umc) is systematically applied.

Eligibility criteria:
inclusion criteria: * case reported in the french pharmacovigilance database from 01/01/1985 to 16/05/2017 * case reported in the eudract database to may 2017 * adverse event reported were including the meddra terms: soc cardiac disorders; soc vascular disorders; hlt death, sudden death; hlgt water, electrolyte and mineral investigations; hlgt cardiac and vascular investigations (excl enzyme tests); and pt syncope. * patients treated with hormonal therapies included in the atc l02, and g03 exclusion criteria: * chronology not compatible between the drug and the toxicity

Keywords: cardiotoxicity abiraterone acetate androgen antagonist
phase 1/2a, randomized, double-blind, placebo-controlled, study to assess safety, tolerability, pk and pd response of pb1023 injection following single and multiple sq doses in adults with type 2 diabetes mellitus

Conditions: Diabetes Mellitus, Type 2

Summary: primary objective: to evaluate the safety and tolerability of single and multiple ascending doses of pb1023 administered as a subcutaneous (sc) injection in adult subjects with t2dm. secondary objectives: 1. to characterize the pharmacokinetic profile of pb1023 after single and multiple ascending doses of pb1023. 2. to assess the pharmacodynamic response of various single and multiple doses of pb1023 (daily fasting plasma glucose, and serial glucose, c-peptide and insulin levels in response to a liquid mixed meal tolerance test (mmtt).


Eligibility criteria:
inclusion criteria: * males or post menopausal or surgically sterile females age 18-75 years of age inclusive. * diagnosed with t2dm for \> or = 6 months with hba1c \> or = 6.0% but \< or = 9.0% while taking stable doses of one oral antihyperglycemic agent but \< or = 8.5% when taking two oral antihyperglycemic agents for up to a maximum of 3 months prior to screening. * fasting plasma glucose between 115 mg/dl and 269 mg/dl. * fasting c-peptide of \> or = 0.8 ng/ml. * bmi \< or = 40 kg/m2. * otherwise stable health except for t2dm. exclusion criteria: * currently taking a non-oral antihyperglycemic agent. * have taken a pparg agonist within 90 days of screening. * known allergy to an approved or investigational glp-1 receptor analog/agonist. * unstable cardiovascular disease as defined in clinical protocol. * history, symptoms or signs of pancreatitis or severe gastrointestinal disease. * personal or family history of medullary thyroid tumors history of multiple endocrine neoplasia syndrome type 2. * poor glucose control as defined in clinical protocol. * clinically significant renal and/or hepatic dysfunction as defined in clinical protocol. * absolute requirement for corticosteroids or received systemic steroids within 90 days prior to pb1023 administration. * pregnant or lactating females. * known history or active alcohol or drug abuse within 12 months prior to screening. * positive for hiv, hepatitis b surface antigen or hepatitis c antibodies. * participating in any other study within 30 days prior to screening. * other medical or psychiatric condition which in the opinion of the investigator would place the subject at increased risk.
the does optical coherence tomography optimize revascularization (doctor) recross study

Conditions: Coronary Disease

Summary: prospective, controlled, double randomized, non-blinded, multicenter, investigator initiated, academic superiority trial comparing optical coherence tomography (oct) guided vs. angiography guided wire recrossing in jailed side branches (sb) (1. randomization 1:1)(superiority) and comparing medtronic resolute integrity and xience prime for stent strut apposition in the sb ostium (2. randomization 1:1) (superiority). acute primary endpoint and 30 days clinical follow-up. hypothesis: oct guided wire recrossing in bifurcation stenting results in less malapposed struts in the segment facing the sb ostium. secondary hypothesis: treatment by medtronic resolute integrity stent results in less malapposed struts at the bifurcation segment compared to treatment by the abbott xience prime stent.

purpose: to assess the ability of oct to guide wire recrossing and reduce stent strut malapposition after kissing balloon dilatation. to compare stent strut apposition after treatment by two different stent designs using both guiding strategies of wire recrossing.

Eligibility criteria:
inclusion criteria: * stable or unstable angina pectoris or silent angina pectoris. * de novo coronary bifurcation lesions at "lad/diagonal", "cx/obtuse marginal", "right coronary artery (rca)- posterior descending artery (pda)/posterolateral branch" or "left main (lm)/cx/lad". * all medina classes except medina 0.0.1. * diameter of side branch ≥2.5 mm. * diameter stenosis \>50% by operator's visual assessment * signed informed consent exclusion criteria: * st-elevation infarction within 48 hours. * side branch lesion length \>5 mm. * expected survival \< 1 year * severe heart failure (nyha≥iii) * s-creatinine \>120 µmol/l. * allergy to contrast media, aspirin, clopidogrel, ticagrelor, ticlopidine, everolimus or zotarolimus.

Keywords: coronary angiography (cag) percutaneous coronary intervention (pci) oct stent