Kornimate/medical-research-clean huggingface dataset:
a double-blind, randomized, placebo-controlled, multicenter, phase iii study of tariquidar + vinorelbine as first-line therapy in non-small cell lung cancer (nsclc)

Conditions: Stage IIIb Non-small Cell Lung Cancer; Stage IV Non-small Cell Lung Cancer

Summary: to determine whether tariquidar + first-line single agent vinorelbine chemotherapy in patients with stage iiib/iv nsclc will, with an acceptable safety profile, significantly improve overall survival compared with placebo + vinorelbine. to compare the effects of tariquidar/vinorelbine with placebo/vinorelbine on tumor response, time to disease progression, performance status, symptom progression, and quality of life in patients with stage iiib/iv nsclc.


Eligibility criteria:
inclusion criteria: 1. patients who have histologically or cytologically proven nsclc, stage iiib or stage iv, requiring first-line chemotherapy. 2. patients who have a who performance status of 2 and life expectancy of greater than 3 months. 3. patients who are 18 years of age or older and age of consent. 4. patients who are women of child-bearing potential must not be pregnant or lactating, must have a negative pregnancy test (serum or urine) at screening, and must be practicing an adequate method of birth control. 5. patients who have neutrophils greater or equal to 1.5 x 103/µl; platelets greater or equal to 100 x 103/µl; bilirubin less or equal to 1.5 times the upper limit of normal or less or equal to 26 µmol/l (1.5 mg/dl); transaminases less or equal to 2.5 times the upper limit of normal or, for patients with known liver metastases, less or equal to 5 times the upper limit of normal; and creatinine equal or less than 141 µmol/l (1.6 mg/dl) or calculated creatinine clearance less or equal to 60 ml/min prior to study treatment. 6. patients who are able to give written informed consent and comply with the protocol. exclusion criteria: 1. patients who are eligible for radiotherapy or surgery for curative intent. 2. patients who have had previous chemotherapy for nsclc. 3. patients who have a who performance status less than 2 or greater than 2. 4. patients with bronchoalveolar carcinoma (an adenocarcinoma in which cylindrical tumor cells grow upon the walls of pre-existing alveoli, from who histological typing of lung tumors \[66\]). 5. patients who have previous or current primary malignancies at other sites within the last 5 years, with the exception of adequately treated cone-biopsied carcinoma of the cervix and basal or squamous cell skin carcinoma. 6. patients who are a poor medical risk because of other nonmalignant systemic diseases or active uncontrolled infections. 7. patients who have symptomatic brain metastases. 8. patients who have other medical or surgical conditions that would contraindicate chemotherapy. 9. patients who have received experimental therapies within the last 4 weeks. 10. patients who have know hypervitaminosis or known sensitivity to ascorbic acid, vitamin a, vitamin d, thiamine, riboflavin, pyridoxine, niacinamide, d-panthenol, or vitamin e.
assessing dementia risk in the community: the dementia population risk tool

Conditions: Dementia

Summary: the purpose of this study is to develop and validate the dementia population risk tool (demport) algorithm to predict dementia incidence in the population setting.

the burden of disease from dementia is a growing global concern as incidence increases exponentially with age and average life expectancy has been increasing around the world. planning for an aging population requires reliable projections of future dementia prevalence and resource requirements, however, existing population projections are simple and have poor predictive accuracy. the dementia population risk tool (demport) will predict incidence of dementia in the population setting using multivariable modeling techniques. the derivation cohort will consist of elderly ontario respondents of canadian community health survey (cchs) (2001, 2003, 2005, 2007; approximately 19 000 males and 25 000 females). pre-specified predictors include sociodemographic, general health, behavioral, functional and health condition variables. incident dementia will be identified through individual linkage of survey respondents to population-level administrative health care databases. using time of first dementia capture as the primary outcome and death as a competing risk, sex-specific proportional hazards regression models will be estimated. the 2008/2009 cchs survey be used for validation (approximately 4 600 males and 6 300 females). overall calibration and discrimination will be assessed as well as calibration within predefined subgroups of importance to clinicians and policy makers.

Eligibility criteria:
inclusion criteria: * respondents to the canadian community health surveys exclusion criteria: * less than 55 years of age at survey administration * prior history of dementia * not eligible for ontario's universal health insurance program
efficacy of 20% autologous serum drops in the treatment of corneal epitheliopathy associated with antihypertensive glaucoma drops.

Conditions: Corneal Epitheliopathy; Glaucoma; Corneal Disease; Dry Eye

Summary: introduction: glaucoma is the second leading cause of blindness globally. most anti-hypertensive drops contain preservatives harmful to the corneal epithelium, with up to 78% of treated patients reporting dry eye symptoms. autologous serum eye drops (ased), contains essential growth factors and nutrients which may promote corneal and conjunctival integrity, offering benefits over traditional treatments. this study investigates the efficacy of 20% ased over placebo in the treatment of corneal epitheliopathies in patients with glaucoma treated with antihypertensive drops. methods: the present study is a triple-blinded, randomized controlled trial that anticipates to enroll 25 patients (50 eyes) with bilateral corneal epitheliopathy secondary to antihypertensive glaucoma treatments. patients will receive autologous serum eye drops in one eye and placebo in the contralateral eye for two months, in addition to standard artificial tears treatment. the primary outcome is the comparison of national eye institute (nei) scores between autologous serum drops and placebo-treated eyes at two months. secondary outcomes include schirmer's test scores, visual acuity, tear break-up time (tbut), ocular surface disease index (osdi) scores, intraocular pressure, and complication rates. the study aims to analyze the effectiveness of autologous serum eye drops in treating corneal epitheliopathies in glaucoma patients, potentially offering a new therapeutic avenue.


Eligibility criteria:
inclusion criteria: * patients with glaucoma who developed corneal epitheliopathy secondary to antihypertensive drops; * epitheliopathy refractory to conventional therapies (artificial tears, ointment, topical cyclosporine or punctal plug, etc.); * national eye institute score of 3 or more for both eyes; * adults aged 18 to 90 years inclusively. exclusion criteria: * corneal epitheliopathy of other origin (ie. mechanical, neurotrophic, toxic, post-infectious, limbal stem cell deficiency); * glaucoma surgery within the last six (6) months; * previous corneal surgery; * active autoimmune disease; * frequent contact lense wear; * pregnant or actively breast-feeding; * known systemic infection with hiv, hepatitis b and c or syphilis; * known severe anemia (hb \< 100 g/l); * inability to give informed consent
characteristics of patients with necrotizing soft tissue infections

Conditions: Necrotizing Soft Tissue Infection

Summary: to study the demographic characteristic of patients with necrotizing soft tissue infections.

at aarhus university hospital, denmark, all patients with necrotizing soft tissue infections will be registered in a database in order to be able to describe their symptoms, demographic variables and thier treatment (surgery, time to surgery, antibiotics, intensive care unit, laboratory data etc).

Eligibility criteria:
inclusion criteria: * patients diagnosed with necrotizing soft tissue infections and treated at aarhus universital hospital
safety of single doses of sar113945 and efficacy and safety of a new formulation given into the knee in osteoarthritis patients / part ii

Conditions: Knee Osteoarthritis

Summary: study objectives: * part 1 tdu11685 to assess in patients with knee osteoarthritis (oa), the safety, tolerability and pharmacokinetics (pk) of single intra-articular doses of sar113945. * part 2 act12505 to assess in patients with knee oa, the efficacy, safety and tolerability of a single intra-articular dose of sar113945.

- screening will be performed within 28 days of dosing. following the single dose of study medication, the study period for each patient will be 168 days.

Eligibility criteria:
inclusion criteria : diagnosis of primary knee osteoarthritis, based upon the following: * x-ray or magnetic resonance imaging (mri) evidence within the last 6 months for joint space narrowing and osteophyte formation * patients will be kellgren and lawrence classification ii/iii, and total western ontario mcmaster (womac) score 24 -72. * patients fulfilling the american college of rheumatology clinical and radiographic criteria for osteoarthritis. exclusion criteria: * patients younger than 40 years * women of child bearing potential. * women either sterilized for more than 3 months, or post-menopausal for more than 12 months. menopause is defined as over age of 60 years or being amenorrheic for at least 2 years with plasma fsh level \>30 iu/l. * secondary osteoarthritis: e.g., autoimmune disease, joint dysplasia, aseptic osteonecrosis, acromegaly, paget's disease, ehlers-danlos syndrome, gaucher's disease, stickler's syndrome, joint infection, haemophilia, haemochromatosis, calcium pyrophosphate deposition disease, or neuropathic arthropathy. * presence of local skin abnormality at the affected knee joint. * intra-articular injection within 3 months. the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
evaluation of the feasibility, safety, and efficacy of single-use endobronchial silicon spigots for the treatment of refractory pneumothorax

Conditions: Pneumothorax

Summary: study objective: to evaluate the feasibility and safety of the disposable endobronchial silicon spigots for treating refractory pneumothorax and to preliminarily assess its efficacy, providing domestic experience for the development and clinical application of bronchial occlusion. study population: patients intended to receive selective bronchial occlusion technology for the treatment of refractory pneumothorax. sample size: this study is a preliminary exploration of the application value of the disposable endobronchial silicon spigots occlusion technology in refractory pneumothorax. the sample size has not been strictly calculated, and it is expected to include 10 patients. study design: this study is an exploratory, single-group, single-center clinical study.


Eligibility criteria:
inclusion criteria: * subjects must meet all of the following criteria to be enrolled: 1. male or female, aged ≥18 years; 2. patients with various types of pneumothorax who still have persistent air leaks after continuous intercostal drainage for 7 days; 3. after evaluation by the researcher, the subject is feasible for the bronchoscopic procedure of selective bronchial occlusion to treat refractory pneumothorax, and the responsible bronchus can be determined by the balloon detection; 4. voluntarily participate in this trial and sign an informed consent form. exclusion criteria: * subjects with any of the following conditions cannot be selected: 1. allergic to silicone materials; 2. contraindications for bronchoscopy: * myocardial infarction within the past month; * active massive hemoptysis; * platelet count \<20×10\^9/l; * pregnancy; * malignant arrhythmias, unstable angina, severe cardiopulmonary dysfunction, hypertensive crisis, severe pulmonary arterial hypertension, intracranial hypertension, acute cerebrovascular events, aortic dissection, aortic aneurysm, severe mental illness, and extreme systemic exhaustion, etc. 3. uncontrolled acute pulmonary infection or severe chronic infection at the intended occlusion lobes or segments; 4. obvious hemodynamic instability or unstable respiratory failure; 5. the responsible bronchus cannot be determined by balloon detection; 6. the researcher believes that the patient has other conditions that are not suitable for inclusion in this study.

Keywords: pneumothorax spigots air leakage bronchial occlusion
coring out fistulectomy with closure of internal sphincter opening versus lay open fistulotomy and primary sphincter repair in transsphincteric perianal fistula

Conditions: Coring Out; Fistulectomy; Internal Sphincter; Lay Open Fistulotomy; Sphincter Repair; Transsphincteric Perianal Fistula

Summary: this study aimed to compare the surgical outcomes of coring out fistulectomy with the closure of internal sphincter opening versus lay open fistulotomy (modified lift) and lay open fistulotomy and primary sphincter repair in trans-sphincteric perianal fistula

fistula-in-ano is a common medical problem affecting thousands of patients annually. symptoms generally affect quality of life significantly, and they range from minor discomfort and drainage with resultant hygienic problems to sepsis. different classifications have been put forward which categorize these fistula into low or high simple or complex, or according to their anatomy inter-sphincteric, trans-sphincteric, and supra- sphincteric or extra-sphincteric. conventional laying-open technique in high perianal fistula may involve sacrifice of part or whole of the sphincter muscle impairing continence. a transposition technique for the management of high anal and anorectal fistulae is described by mann and clifton in 1985. the method involves re-routing the extrasphincteric portion of the track into an intersphincteric position with immediate repair of the external sphincter. coring-out fistulectomy is a type of sphincter-preserving procedure that enables accurate resection of the fistula tract alone and thus reduces the possibility of missing a secondary tract

Eligibility criteria:
inclusion criteria: * age more than 18 years old. * both sexes. * american society of anesthesiology (asa) physical status i, ii. * fistula in ano, trans-sphincteric type exclusion criteria: * patients with low perianal fistula. * recurrent perianal fistula. * associated anal conditions such as (piles, anal fissures, and rectal prolapse). * patients with inflammatory bowel disease or tuberculosis. * patients with acute perianal abscess. * patients with major incontinence.
immunogenicity, safety, tolerability and ability to prime for memory of meningococcal c conjugate vaccine in healthy children

Conditions: Prevention of Meningococcal Infection

Summary: immunogenicity, safety, tolerability and ability to prime for memory of meningococcal c conjugate vaccine in healthy children

the aim of this study is to investigate the immunogenicity offered by mencc vaccine when administered in different schedules at different years of life: 2 doses in the first year of life given 2 months apart (at 2 and 4 months of age), with a booster in the second year of life, or 1 dose in the first year of life (at 2 or 6 months of age), with a booster in the second year of life, or only 1 dose in the second year of life.

Eligibility criteria:
inclusion criteria: * healthy infants exclusion criteria: * known hypersensitivity to any vaccine component * significant acute or chronic infections * previously ascertained or suspected disease caused by n. meningitidis * previous household contact with an individual with a positive culture of n. meningitidis serogroup c

Keywords: prevention of meningococcal meningitis meningococcal vaccines conjugate immunology infant antibody persistence
effect of laparoscopy-assisted distal gastrectomy for locally advanced gastric cancer

Conditions: Gastric Cancer

Summary: the purpose of this study is to evaluate the effect and safety of laparoscopy-assisted d2 radical surgery for distal advanced gastric cancer.

in both arms,subtotal gastrectomy (dissect more than 2/3 of stomach and total omentectomy) and d2 lymph node dissection (around common hepatic artery, celiac artery, proximal part of splenic artery (4d, 4sb), hepatoduodenal ligament, superior mesenteric vein) wiil be performed basically. as a general rule, billroth i or billrothii methods will be used for gastric reconstruction for all cases. for anastomosis, absorbable suture is used. anastomotic diameter is 5\~6 cm length. drainage tube is inserted through the right flank area and additional drainage tubes can be inserted as needed.

Eligibility criteria:
inclusion criteria: 1. age: older than 18 years old，including 18 years old 2. pathologic finding by gastric endoscopy: confirmed gastric adenocarcinoma (papillary adenocarcinoma, tubular adenocarcinoma, mucinous adenocarcinoma, signet ring cell carcinoma, poorly differentiated adenocarcinoma) 3. cancer core: located at lower part of stomach 4. preoperative cancer stage : ct2-4a,n0-3,m0 (according to ajcc-7th tnm staging) 5. surgery：subtotal gastrectomy (dissect more than 2/3 of stomach and total omentectomy) and d2 lymph node dissection 6. asa score: ≤ 3;ecog performance status 0/1 7. informed consent patients (explanation about our clinical trials is provided to the patients or patrons, if patient is not available) exclusion criteria: 1. concurrent cancer patients or patient who was treated due to other types of cancer before the patient was diagnosed as a gastric cancer patient 2. patient who was treated by other types of treatment methods, such as chemotherapy, immunotherapy, or radiotherapy 3. patient who was received upper abdominal surgery (except, laparoscopic cholecystectomy) 4. patient who was treated because of systemic inflammatory disease 5. pregnant patient or lactating women 6. patient who suffer from bleeding tendency disease, such as hemophilia or patient taking anti-coagulant medication due to deep vein thrombosis 7. serious mental illness 8. gastric surgery (including for gastric esd / emr) 9. imaging examinations showed regional integration lymph nodes (maximum diameter ≥ 3cm) 10. other malignant diseases in 5 years 11. have unstable angina or myocardial infarction within six months 12. have cerebral infarction or cerebral hemorrhage within 6 months 13. sustained systemic glucocorticoid treatment history within 1 month 14. have other diseases needed operative treatment at the same time 15. complications (bleeding, perforation, obstruction) required emergency surgery 16. pulmonary function tests fev1 \<50% of predicted value.

Keywords: gastric cancer d2 laparoscopic open surgery
moonray-01, a study of ly3962673 in participants with kras g12d-mutant solid tumors

Conditions: Pancreatic Ductal Adenocarcinoma; Non-small Cell Lung Cancer; Colorectal Cancer

Summary: the main purpose of this study is to assess safety \& tolerability and antitumor activity of ly3962673 as monotherapy and in combination with other chemotherapy agents in participants with kras g12d-mutant advanced solid tumor types. the study is expected to last approximately 5 years.


Eligibility criteria:
inclusion criteria: * have histological or cytologically proven diagnosis of locally advanced, unresectable, and/or metastatic cancer and measurable disease per response evaluation criteria in solid tumors (recist) version 1.1. * have evidence of kras g12d mutation in tumor tissue or circulating tumor dna * have an ecog performance status of ≤ 1 * must have received ≥ 1 prior line of systemic chemotherapy for advanced or metastatic disease * participants with asymptomatic or treated cns disease may be eligible. exclusion criteria: * have known active cns metastases and/or carcinomatous meningitis. * have any unresolved toxicities from prior therapy greater than national cancer institute (nci) common terminology criteria for adverse events (ctcae) v5.0 grade 1. * have significant cardiovascular disease as unstable angina or acute coronary syndrome, history of myocardial infarction, known reduced left ventricular ejection fraction. * have active uncontrolled systemic bacterial, viral, fungal, or parasitic infection. * have known active hepatitis b virus (hbv) and hepatitis c virus (hcv). * have other active malignancy unless in remission with life expectancy greater than (\>) 2 years.

Keywords: kras g12d kras ly3962673 cetuximab nab-paclitaxel gemcitabine oxaliplatin leucovorin irinotecan 5-fluorouracil
consequence of dexmedetomidine on emergence deliruim after sevoflurane anesthesia in children with cerebral palsy

Conditions: Emergence Deliruim; Cerebral Palsy

Summary: the purpose of this study is to determine whether dexmedetomidine is effective in the treatment of emergence deliruim after sevoflurane anesthesia in children with cerebral palsy.


Eligibility criteria:
inclusion criteria: non-quadriplegic (mono-,di-, hemiplegic) children with cp that are scheduled for elective achilles-tendon lengthening procedure guangzhou women and children's medical center, guangzhou, china, with american society of anesthesiologists (asa) physical status i or ii. exclusion criteria: participants that displayed symptoms of sinus bradycardia and atrio-ventricular block, non-communicative severe developmental delay, seizure disorders, and treatment with seizure medications

Keywords: children
mitral splay sign, its mechanism and association with severity of regurgitation

Conditions: Mitral Regurgitation

Summary: to study echocardiography splay sign in mitral regurgitation and its association with mitral regurgitation severity and doppler band artifact ('seagull cry').


Eligibility criteria:
inclusion criteria: * any patient undergoing echocardiography for clinical indications exclusion criteria: * poor quality of recorded echocardiography study * inability to ascertain severity of mitral regurgitation

Keywords: echocardiography splay sign seagull cry