Kornimate/medical-research-clean huggingface dataset:
a study of pemetrexed plus cisplatin with concurrent radiation therapy followed by docetaxel consolidation in patients with inoperable squamous cell lung cancer

Conditions: Squamous Cell Lung Cancer

Summary: to evaluate the efficacy and toxicity of patients with inoperable squamous cell lung cancer treated with pemetrexed plus cisplatin with concurrent radiation therapy followed by docetaxel consolidation. an exploratory biomarker analysis in blood and tumor samples is also planned.


Eligibility criteria:
inclusion criteria: * newly diagnosed stage iiia/ iiib squamous cell lung cancer; * all sites of disease must be amenable to definitive radiotherapy; * age 18 years to 75 years; * eastern cooperative oncology group (ecog) performance status 0-2; * forced expiratory volume in 1 second(fev1)\> 0.75l; * no previous chest radiotherapy, immunotherapy or biotherapy; * adequate bone marrow, liver and renal function, as specified below: absolute neutrophil count (anc) ≥ 1.5 x 109/l; hemoglobin ≥ 8 g/dl; platelets ≥ 100 x 109/l; serum total bilirubin ≤ 1.5 x upper limit of normal (uln) ; aspartate transaminase(ast) and alanine transaminase(alt) ≤ 2.5 x uln or ≤ 5 x uln if liver metastases are present; serum creatinine ≤ 1.5 x upper limit of normal or creatinine clearance ≥ 60ml/min for patients with creatinine levels above institutional normal. * for women of child-bearing potential, negative pregnancy test within 14 days prior to starting treatment * men and women of childbearing age must be willing to use effective contraception while on treatment and for at least 3 months thereafter; * patients and their family signed the informed consents; exclusion criteria: * active infection; * history of significant cardiac disease (unstable angina, congestive heart failure, myocardial infarction within the previous 6 months, ventricular arrhythmias); * malnutrition (loss of ≥ 20% of the original body weight); * performance status: 3-4; * sensor or motor neuropathy \> grade i; * second primary malignancy, except for non-melanoma skin cancer; * psychiatric illness or social situation that would preclude study compliance; * pregnant or lactating women.

Keywords: squamous cell lung cancer pemetrexed radiosensitivity
ablator ablation observational registry

Conditions: Atrial Fibrillation

Summary: the purpose of this registry is to assess the performance and clinical effectiveness of a combination of sjm mapping and ablation products in the treatment of subjects with atrial fibrillation (af).

the objectives of this registry are the following: * to confirm patient safety as part of the post market surveillance study. * to assess performance of a combination of sjm products during procedures. * to assess the learning curve with a combination of sjm products. * to collect operator feedback on a combination of sjm products. all patients from participating sites who are indicated for an atrial fibrillation ablation procedure and willing to provide written informed consent may be enrolled in this registry. in order to ensure a minimum level of uniformity across site practices and to enable comparison of acute and long-term effectiveness as well as procedure efficiency according to technique used, a combination of 2 types of devices from the pre-specified list must be used to be eligible in this registry.

Eligibility criteria:
inclusion criteria: all patients who are indicated for an atrial fibrillation ablation procedure. exclusion criteria: pregnant women.
effect of regulated pleural pressure on air leak and fluid drainage following pulmonary resections: a multicenter randomized trial

Conditions: Lung Cancer

Summary: the objective of this randomized study is to compare the effect of two controlled chest tube protocols on the duration of air leak and fluid drainage following pulmonary lobectomy or segmentectomy by using an electronic regulated chest drainage system (thopaz). previous studies have suggested that the amount of negative pressure used at the level of the chest drainage device may affect the duration of air leak, but the results have been inconsistent, however as revealed in more recent studies understanding of the physics of chest drainage devices may have been confounded by lack of regulation of the pleural pressure. in addition, experimental studies have shown that fluid drainage may be affected by the degree of negative pleural pressure applied.


Eligibility criteria:
inclusion criteria: * able and willing to read, understand, and provide written informed consent; * age range of 18-90 years; * patients submitted to lobectomy, segmentectomy and bilobectomy due to lung cancer or other intrathoracic lesions. both open and minimally invasive (thoracoscopic) resections are acceptable. exclusion criteria: * if patients are submitted to lung resection associated with chest wall resection or diaphragm resection the patient will be excluded from analysis * if during the postoperative hospital course there is a need for postoperative mechanical ventilation or hemodynamic instability the patient will be excluded from analysis. * if the subject meets all of the inclusion criteria and none of the exclusion criteria, he/she is eligible to participate in the study.
efficacy assessment of lamina curved plate in managing oroantral communication (oacs)

Conditions: Oroantral Fistula

Summary: the aim of this study is to assess the success rate, of using a lamina curved plate (osteobiol® laboratory) in the treatment of persistent oacs over 5mm.

oroantral communication (oac) is an abnormal opening that forms between the maxillary sinus and oral cavity. this communication can occur as a result of tooth extraction, maxillofacial surgery or dental infections. microorganisms from the oral cavity can then colonise the maxillary sinuses, leading to infections. prompt and effective management of a oac is essential to prevent complications such as acute or chronic sinusitis, facial pain or inflammation. closure is usually made surgically with a local flap such as fat pad flap, palatal or vestibular flap or with natural or synthetic biomaterials. however, oacs may persist even after attempted closure, and there is also a risk of facial nerve damage during the dissection of the bichat's flap. all these factors prompt the evaluation of surgical procedures employed in the treatment of oacs, including the use of the lamina curved biomaterial from osteobiol®. this biomaterial comprises a decalcified flexible plate made of heterologous cortical bone. it serves to reconstruct the sinus floor and isolate the sinus from the oral cavity. the plate is secured using osteosynthesis screws and possesses the characteristic of being resorbable. the objective of this study is to investigate the success rate, of utilizing the lamina curved plate (osteobiol® laboratory) and to provide surgeons with an additional reference technique for treating oacs larger than 5mm.

Eligibility criteria:
inclusion criteria : * all patients with persistent oac greater than 5mm treated with the use of an osteobiol® lamina curved plate * age ≥ 18 years * patients informed of the study and who did not object. exclusion criteria : * follow-up less than 1 month after surgery * patient under guardianship

Keywords: oroantral fistula lamina curved plate oral surgery chronic sinusitis
a study to evaluate the safety, tolerability and efficacy of multiple doses of js002 in patients with hyperlipidemia..

Conditions: Hyperlipemia

Summary: js002 is a recombinant humanized anti-pcsk9 monoclonal antibody.


Eligibility criteria:
inclusion criteria: 1. signed informed consent. 2. age ≥18 and ≤65 years old; 3. body mass index (bmi) ≥18 and ≤ 30 kg/m2; 4. subjects who are receiving statin therapy at the time of screening or who are eligible for statin therapy can receive a stable dose of statin therapy for more than 28 days before randomization and are willing to maintain stable statin therapy during the study; 5. low-density lipoprotein cholesterol (ldl-c) level ≥2.6mmol/l for subjects who are receiving statin and/or other lipid-lowering therapy at the time of screening, or ldl-c≥ 4.1mmol/l for subjects who didn't receive any-lowering therapy at the time of screening, and ldl-c still ≥2.6mmol/l before randomization; 6. fasting triglycerides ≤4.5 mmol/l; exclusion criteria: 1. diagnosis of homozygous familial hypercholesterolemia; 2. history of new york heart association (nyha) defined ⅱ - ⅳ heart failure; 3. history of uncontrolled arrhythmiast; 4. history of myocardial infarction, history of ptca or pci or cabg, history of unstable angina befor 90 days of randomization; 5. history of stroke or tia； 6. uncontrolled hypertension with sbp≥160mmhg and/or dbp≥100mmhg 7. type 1 diabetes, or type 2 diabetes that is or poorly controlled（hba1c\> 8.0%);
macular pigment measurements in eye & other tissues

Conditions: Macular Pigmentation; Skin Pigment

Summary: the purpose of this study is to understand the role of nutrition and its effects on the eye and other tissues. the investigators propose to study this by validating and correlating various non-invasive measurement methods of carotenoid concentrations in the human eye and skin tissue. a secondary objective is to correlate blood levels of carotenoids on a sub-set of participants.

the macula of the human retina (the structure responsible for high acuity vision essential for reading, driving and recognizing faces) is colored an intense yellow due to the deposition of two carotenoid compounds, lutein and zeaxanthin. these xanthophyll carotenoids are derived exclusively from the diet, and are hypothesized to protect the macula from light-induced oxidative damage by virtue of their light-screening and antioxidant properties. epidemiological studies have shown that high dietary intake and blood levels of lutein and zeaxanthin are associated with lower rates of vision loss due to age-related macular degeneration (amd). it is of interest to correlate carotenoid levels in the eye and skin tissues with blood levels of carotenoid compounds.

Eligibility criteria:
inclusion criteria: * any patient age 7 or older, undergoing routine dilated ophthalmology examinations at the moran eye center will be eligible to participate. * patients with adult vitelliform dystrophy. (this condition initially presents in adulthood as bilateral subtle and often asymptomatic macular lesions, which are often misdiagnosed as early age-related macular degeneration (amd)). exclusion criteria: * patients under age 7 will not be eligible to participate.
optimization of spect imaging

Conditions: Coronary Artery Disease

Summary: single photon emission computed tomography (spect) is a 3d nuclear medicine imaging technique that is used extensively to study the heart and diagnose heart disease. there are three major limitations in spect imaging: attenuation or loss of signal, scattering of the signal in the patient tissues and resolution, where the signal gets blurrier the further the nuclear activity is away from the camera. new software, evolution for cardiactm, by ge healthcare and new cameras with computed tomography (ct) decrease the time needed for images to be obtained while maintaining image quality. evaluation is needed before they become standard of care.


Eligibility criteria:
inclusion criteria: * intermediate to high risk patients with coronary artery disease who are scheduled for routine spect or pet perfusion imaging exclusion criteria: * pregnancy and breast feeding * severe narrowing (stenosis) of the aortic valve * severe heart failure

Keywords: diagnostic imaging single photon emission computed tomography positron emission tomography computed tomography attenuation resolution scatter radiopharmaceutical
phenotypes and vascular damage in chronic obstructive pulmonary disease (copd)

Conditions: Chronic Obstructive Pulmonary Disease

Summary: topdocs is a prospective cohort study including copd patients from currently six study centers in switzerland. patients with copd gold stages i-iv will be enrolled and followed-up annually for at least 3 years. yearly assessments will include a detailed patient history, quality of life and activity questionnaires, history of exacerbations, lung function, measurements of exercise capacity, measurements of vascular function, exhaled breath analysis and blood sampling. the overall objective of the project is to establish a meticulously characterized cohort of copd patients living in switzerland in order to allow high quality research on the pathogenesis, treatment and complications of copd. the specific aim of the project is to determine clinically relevant copd phenotypes and biological factors influencing vascular function in copd patients.


Eligibility criteria:
inclusion criteria: * proven copd (gold stages i-iv) * age: 40-75 years exclusion criteria: * mental or physical disability precluding informed consent or compliance with the protocol * acute or recent (within the last 6 weeks) exacerbation of copd

Keywords: copd cardiovascular disease phenotypes
a study of ly3303560 in participants with early symptomatic alzheimer's disease

Conditions: Alzheimer Disease (AD)

Summary: the purpose of this study is to evaluate the safety and efficacy of a study drug that targets an abnormal protein in the brain found in people with alzheimer's disease (ad).


Eligibility criteria:
inclusion criteria: * participants must have gradual and progressive change in memory function for \>6 months. * participants must have a family member or close friend who is with you at least 10 hours per week and can attend study appointments. exclusion criteria: * participants must not have significant neurological disease affecting the nervous system, other than ad, that affects cognition or may affect completion of the study. * participants must not have serious or unstable illness that could interfere with the analysis of the study or has a life expectancy \<24 months. * participants must not have history of cancer within the last 5 years with the exception of certain types of skin, cervical, prostate, and other cancers that are not likely to recur or spread. * participants must not have serious risk for suicide. * participants must not have history of drug or alcohol use disorder within the last 2 years. * participants must not have multiple severe drug allergies * participants must not have hiv, hepatitis b or hepatitis c * participants must not be receiving gamma globulin (igg) or intravenous immunoglobulin (ivig) therapy

Keywords: memory problems cognitive impairment periscope-alz dementia tauopathy neurofibrillary tangles
inflammation and clotting abnormalities in aneurysmal coronary artery disease

Conditions: Coronary Artery Aneurysm; Abdominal Aortic Aneurysm; Coronary Disease

Summary: the main objective of the care-aneurysm project is to evaluate inflammation and clotting abnormalities in patients with aneurysmal coronary artery disease in relation to patients with abdominal aortic aneurysm or coronary artery disease (acting as controls).

the trial will enrol 180 patients, 60 in each of three groups: 1) aneurysmal coronary artery disease; 2) abdominal aortic aneurysm; 3) coronary artery disease. in addition, up to 250 patients with aneurysmal coronary disease will be follow for clinical outcomes in relation to controls (prognosis group). the primary research question of this project is to evaluate wheter the inflammation and clotting abnormalities in patients with aneurysmal coronary artery disease differ from ones in abdominal aortic aneurysm or coronary artery diseases. study endpoints include the level of inflammation biomarkers and fibrin clot properties in each cohort.

Eligibility criteria:
inclusion criteria: * age 18-85 years old * angiographically confirmed coronary artery ectasia or aneurysm (arm i) * abdominal aortic aneurysm (arm ii) * angiographically confirmed coronary artery disease (arm iii) exclusion criteria: * less than 12 months from acs * actual oral anticoagulant therapy * actual antiplatelet therapy other than aspirin * heart failure nyha iv * untreated hyperthyroidism or hypothyroidism * severe comorbidities * lack of consent

Keywords: coronary artery aneurysm inflammation fibrin clot lysis time coronary disease abdominal aortic aneurysm
does adding bevacizumab therapy in glaucoma surgery improve the success of needle bleb revisions?

Conditions: Glaucoma

Summary: the purpose of this study is to see if a new add on (or adjunctive) therapy used in glaucoma surgery improves the success of needle bleb revisions.

to investigate the efficacy of needle bleb revisions with mitomycin c with subconjunctival bevacizumab in promoting both filtering success and favorable bleb morphologic features.

Eligibility criteria:
inclusion criteria: * require glaucoma bleb needle revision with mitomycin-c exclusion criteria: * pregnant, nursing, or not using adequate contraception * other glaucoma eye surgery involving tube shunts * prior retinal detachments surgery with scleral buckle * infection, inflammation, or any abnormality preventing eye pressure measurement * enrolled in another investigational study

Keywords: failing blebs failing express shunt avastin bevacizumab glaucoma prior trabeculectomy express shunt placed under a scleral flap subsequent filtration failure
pharmacokinetics and safety of ivig nanogam 100 mg/ml

Conditions: Primary Immunodeficiency

Summary: intravenous immunoglobulin (ivig) is used for treatment of a heterogeneous group of immune related disorders both as immune-replacement and immune-modulating therapy. sanquin developed a 100 mg/ml ivig product (nanogam 100 mg/ml). patient will receive one infusion with nanogam 50 mg/ml as they used to (same dose) and subsequently 4 infusions with nanogam 100 mg/ml (same dose). aim is to show bioequivalency between the 50 mg/ml and the 100 mg/ml product of sanquin.


Eligibility criteria:
inclusion criteria: * primary a- or hypogammaglobulinemia, particularly patients with xla or cvid * stabilised on treatment with nanogam 50 mg/ml with 2-4 weeks intervals in an hospital or at home and willing to be treated with 1 infusion of nanogam 50 mg/ml and 4 infusions of nanogam 100 mg/ml at the hospital * a stable clinical situation (no activity of any other disease; a stable immunoglobulin dose and frequency) * age \>= 18 years * the patient has signed the consent form exclusion criteria: * known with allergic reactions against human plasma or plasma products * having an ongoing progressive disease, including hiv infection * pregnancy or lactation * known with insufficiency of coronary or cerebral circulation * having renal insufficiency (plasma creatinin \> 115µmol/l) * having iga deficiency and anti-iga antibodies have been detected

Keywords: intravenous immunoglobulin pharmacokinetics 10% ivig
feasibility of olive oil for reducing facial pain of trigeminal neuralgia

Conditions: Trigeminal Neuralgia

Summary: this is a 16-week non-blinded, parallel, controlled trial to determine the feasibility and potential efficacy of an olive oil dietary intervention to alleviate facial pain caused by trigeminal neuralgia type 1 (tgn).

trigeminal neuralgia (tgn) pain is debilitating and unpredictable. alleviation of intensity or frequency to any degree will improve the quality of life of the individuals affected. current medical treatments for tgn are often not effective. in some cases, the pain is a result of myelin degeneration. if diet can provide the basic building blocks for myelin regrowth, then the investigators may be able to reduce facial pain by supporting the myelin nerve sheath. animal studies have shown that a dietary intervention with olive oil favorably impacts myelin but no human study has been conducted to date. the investigators propose undertaking a feasibility study to determine if a comparable intervention may work in a similar way in humans. if olive oil impacts myelin repair, then pain will be decreased by this dietary intervention and quality of life will be improved. however, it is not known if individuals with tng will be able to consume a diet relatively high in olive oil. feasibility will include testing the logistics of distributing the olive oil intervention to the study subjects, incorporation of olive oil into the participants' daily diets, and online/distance monitoring of compliance and reporting of pain intensity, pain frequency, and quality of life. this feasibility study will lay the groundwork for potential future studies examining the efficacy of olive oil on alleviating facial pain caused by tng and may provide data for a power analysis for a future interventional trial.

Eligibility criteria:
inclusion criteria: 1. diagnosed with trigeminal neuralgia 2. able to provide written informed consent in english 3. self-identifying females 18-99 years of age 4. willing to consume 60 ml (4 tablespoons) of olive oil and accommodating dietary changes, and thereby achieve weight maintenance. 5. willing to provide information about dietary intake at baseline, at the study midpoint, and at the end of the study to assess dietary changes. 6. willing to complete online questionnaires associated with the study. 7. willing and able to provide a valid social security for study payment purposes. 8. have access to the internet to complete online questionnaires 9. willing to maintain confidentiality of the penn facial pain scale exclusion criteria: 1. do not meet the above criteria. 2. currently participating in another interventional clinical trial.
3d sonographic measurement of volumetric flow in transjugular intrahepatic porto-systemic shunts

Conditions: Portal Hypertension; Liver Disease

Summary: to determine if ultrasound measurements can accurately measure the blood pressure of flow across a stent that has been placed in a portal vein to reduce portal vein pressure known as transjugular intrahepatic porto-systemic shunts or tips.

to determine if 3d ultrasound measurements can accurately measure the pressure of blood flow across a stent that has been placed in a portal vein. this has been done in order to reduce portal vein pressure. these shunts are known as transjugular intrahepatic porto-systemic shunts or tips.

Eligibility criteria:
inclusion criteria: 1. male and female 18 years of age and older 2. have an existing tips (transjugular intrahepatic porto-systemic shunt) 3. have an ultrasound ordered by your physician to evaluate your tips. 4. able to read, understand and sign informed consent exclusion criteria: 1. under 18 years of age 2. cannot be pregnant
intralesional vitamin d injection for treatment of common warts

Conditions: Warts

Summary: researchers are trying to find out if injecting vitamin d into a wart is an effective treatment.


Eligibility criteria:
inclusion criteria: * adult patients seen at the mayo clinic rochester practices * patients suffering from one or more cutaneous warts as diagnosed by the examining physician at baseline visit on typical diagnostic characteristics * able to provide consent * both recalcitrant and non-recalcitrant warts will be included exclusion criteria: * patients with prior use of home or office-based destructive treatments for this wart(s) in the last 1 month with salicylic acid (sa) or cryotherapy * immunoadjuvant therapy for warts in the last 4 months (e.g candida) * history of vitamin d injection of warts ever * high-dose vitamin d supplementation (\>4,000 iu daily or equivalent) in the preceding 3 months * pregnancy or lactation * facial or genital warts * lesions not felt by the examining clinician to be a wart (e.g., corns or calluses) * immunosuppression (to include immunosuppressive medications or conditions as judged by the physician evaluating the patient at the baseline visit). * allergy to sesame oil