Kornimate/medical-research-clean huggingface dataset:
combined cfrt and sabr in stage ii and iii nsclc with peripheral tumors smaller than 5 cm.

Conditions: Inoperable Locally Advanced Non Small Cell Lung Cancer

Summary: a phase i trial is being conducted in patients with inoperable locally advanced nsclc to treat with a combination of conventional fractionated radiotherapy (cfrt) on the mediastinal lymph nodes and stereotactic ablative radiotherapy (sabr)on the primary tumor with concurrent chemotherapy. it is hypothesized that this will lead to an increase of local control and overall survival

in locally advanced nsclc local control has been poor, but with sabr remarkable high local control rates with low toxicity have been reported. currently stage iii and inoperable ii nsclc patients have been treated with imrt and concurrent chemotherapy at out institute. in this study we will explore the combination of sabr and cfrt with concurrent chemotherapy

Eligibility criteria:
inclusion criteria: * cytological or histological proven nsclc stage iii or inoperable stage ii, ct1-2a-3n1-3m0 with peripheral tumors \< 5 cm (chest wall infiltration is no exclusion criteria if the tumor diameter is \< 5 cm). * weight loss \< 10% in the last three months * who-performance status ≤ 2 * patients that receive concurrent chemoradiotherapy, with the exception of adriamycin and gemcitabine * fev1 and dlco \> 40 % of the age-adjusted normal value * minimum required laboratory data bone marrow reserve and hepatic- and renal function * absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule * before patient registration, written informed consent must be given according to gcp and national regulations exclusion criteria: * patients with central tumors \< 2 cm of the proximal bronchial tree (figure 2) or tumors immediately adjacent to mediastinal or pericardial pleura. * patients that receive sequential chemoradiotherapy or radiotherapy only. * patients with grade 3 dyspnea at baseline (according to ctcae version 4.03) * patients with pancoast tumors * prior radiotherapy treatment to the thorax * any contraindications to the administration of thoracic radiotherapy * pregnant women
addition of the interferential current to the pilates method in the treatment of chronic nonspecific low back pain

Conditions: Chronic Nonspecific Low Back Pain

Summary: this study aims to evaluate the effectiveness of the addition of the interferential current to pilates method exercises in the treatment of 148 patients with chronic nonspecific low back pain.


Eligibility criteria:
inclusion criteria: * sedentary patients with chronic nonspecific low back pain longer than 12 weeks * pain greater than three points in pain numerical rating scale exclusion criteria: * contra indications to physical exercise * serious spinal pathologies (e.g. tumors, fractures and inflammatory diseases) * nerve root compromise * pregnancy * infection and/or skin lesions at the site of the application of the interferential current * cancer * cardiac pacemaker * changes in sensitivity or allergy in the region of electrode placement * previous surgery on spine or physical therapy for chronic nonspecific low back pain in the last six months * previous experience with the pilates method

Keywords: pilates-based exercises electrotherapy interferencial current
study to assess the efficacy of vly-686 in relieving symptoms of gastroparesis

Conditions: Gastroparesis

Summary: this is a multicenter, randomized, double-blind, placebo-controlled study to be conducted in the united states. one hundred fifty (150) subjects diagnosed with gastroparesis, who satisfy the selection criteria for the study, will be randomized to one of two treatment groups, active or placebo.

this is a multicenter, randomized, double-blind, placebo-controlled study to be conducted in the united states. one hundred fifty (150) subjects diagnosed with gastroparesis, who satisfy the selection criteria for the study, will be randomized to one of two treatment groups, active or placebo. the study is divided into two phases: the screening phase and the evaluation phase. the screening phase includes a screening visit to evaluate subjects' preliminary eligibility for the study. during the screening phase, subjects will collect diary data for at least 4 weeks. the evaluation phase includes 4 weeks of randomized double-blind treatment.

Eligibility criteria:
inclusion criteria: 1. diagnosed with gastroparesis; 2. subjects must agree to the use of contraception 3. ability and acceptance to provide written informed consent; 4. willing to participate in the pharmacogenomics sample collection; 5. willing and able to comply with all study requirements and restrictions 6. willing to not participate in any other interventional trial for the duration of their participation. exclusion criteria: 1. another active disorder or treatment which could explain or contribute to symptoms in the opinion of the investigator (including but not limited to gastric malignancy, neurological disorder, or heavy doses of strong anticholinergics); 2. pregnancy or nursing; 3. history of intolerance and/or hypersensitivity to medications similar to vly-686 (tradipitant) and its accompanying excipients; 4. use of another nk1 antagonist or palonosetron; 5. exposure to any investigational medication, including placebo, within 60 days of the baseline visit; 6. any other reason as determined by the investigator which may lead to an unfavorable risk-benefit of study participation, may interfere with study compliance, or may confound study results.
standard care with or without early palliative care provided by palliative care specialist in advanced non-small cell lung cancer patients

Conditions: Lung Cancer - Non Small Cell; Lung Cancer (NSCLC)

Summary: early palliative care has been shown to improve the survival of advanced lung cancer patients. however, most of the clinical studies were performed in the era when systemic treatment options for this disease were limited. currently, many effective treatment options are available, including targeted therapy and immunotherapy. these novel agents improve the treatment outcomes while having less toxicity compared to conventional chemotherapy. moreover, medical oncologists are now trained to provide palliative care for patients. this study was designed to demonstrate whether early palliative care provided by the palliative care specialist still improves the quality of life or survival of advanced lung cancer patients compared to standard care provided by the medical oncologist.

advanced non-small cell lung cancer patients initiating a systemic treatment will be randomized to the early palliative care arm (attending a palliative care clinic once a month during the first three months concurrently with oncology clinic appointment) or the standard care arm (attending oncology clinic only). the patients will be asked to complete the quality of life questionnaires (fact-l, eq-5d-5l), mental health questionnaire (phq-9), and pain assessment once a month for three months and at the sixth month.

Eligibility criteria:
inclusion criteria: * age at least 18 years old * pathologically confirmed advanced non-small cell lung cancer * plan to receive systemic treatment for lung cancer within three weeks * ecog performance status 0-2 with estimated life expectancy \> 24 weeks * having at least 4 scores according to edmonton symptom assessment system (esas) * able to complete the questionnaires exclusion criteria: * had received systemic treatment for advanced lung cancer before

Keywords: early palliative care palliative care lung cancer
shared decision making in rural primary care lung cancer screening and smoking cessation

Conditions: Lung Cancer; Smoking Cessation

Summary: the intervention is aimed to improve adherence to the lung cancer screening (lcs) guidelines and centers for medicare and medicaid services (cms) coverage criteria to conduct shared decision-making (sdm) and provide smoking cessation services in rural primary care practices.

the pilot intervention will engage no more than 300 patients using a pragmatic, pre-post design guided by an enhanced re-aim/prism framework. the primary goal of this intervention is to improve lcs practice by offering a formal sdm process and smoking cessation support aligned with the cms coverage criteria. the investigators will conduct a type ii effectiveness implementation hybrid trial using a pre-post design to evaluate the effectiveness (co-primary outcomes of lcs and decision quality) and implementation at four rural clinics. space precludes discussion of pragmatic design features, but this study was designed to be pragmatic using the precis-2 criteria and it scores highly on almost all precis-2 dimensions. each clinic will recruit the minimum of 9 patients eligible to lcs (based on cms guidelines) every 2 months for up to 8 months. the first period of 2 months is for baseline data, the second and every other period of 2 months is for intervention (pre-post design). each patient will receive 2 surveys (one immediately after the doctor's visit and a second one a month later). the intervention will be in the form of patient decision aid (information flyer) the participant receives during a healthcare provider visit.

Eligibility criteria:
inclusion criteria: * asymptomatic to lung cancer symptoms * tobacco smoking history of 20+ pack-years * current smoker or quit within last 15 years exclusion criteria: - a patient that does not meet inclusion criteria
efficacy and tolerability study to treat mild and moderate anxiety

Conditions: Anxiety; Efficacy; Tolerability

Summary: to evaluate the efficacy and tolerability of the combination use of passiflora incarnata l, crataegus oxyacantha and salix alba l in mild and moderate anxiety. clinical study phase iii, multicenter, prospective, open. patients will be included in sufficient quantity to achieve the minimum number of 124 evaluable patients.


Eligibility criteria:
inclusion criteria: * patients who achieve scores between 18 and 29 points in the hamilton scale for anxiety; * individuals of any ethnic group male and female, aged above 18 years; * consent of the subject of research (a consent form signed). exclusion criteria: * patients with known hypersensitivity to any components of the formula; * pregnant women and nursing mothers; * patients with endogenous depression, schizophrenia, suicidal tendency; * patients with heart disease unabated, unabated kidney, liver and lung unabated unabated, at the discretion of the investigator; * addiction to drugs, including alcohol, at the discretion of the investigator; * patients who are using any medication that could interfere with the effect of the drug under study; * impossibility of compliance to the protocol

Keywords: passiflora, crataegus and salix mild and moderate anxiety tablet to evaluate the efficacy and tolerability of the combination
trofosfamide versus adriamycin in elderly patients with soft tissue sarcoma (sts)

Conditions: Sarcoma, Soft Tissue

Summary: the goal of this trial is to determine whether oral continuous (metronomic) therapy with trofosfamide results in a similar rate of progression-free time after 6 months as intravenous treatment with adriamycin. in addition, the study is intended to investigate the level of toxicity associated with the two treatment regimens (safety profile).

group a:adriamycin (60 mg/m2, d1, qd22) 75 mg/m2 may be applied instead of 60 mg/m2 for patients between 60 and 70 years of age (optional) group b:trofosfamide (300 mg absolute p.o. qd over 7 days, then 150 mg p.o. absolute qd continuously) in case of absence of any toxicity during treatment with trofosfamide 150 mg absolute a dose escalation to 200 mg absolute is allowed (optional)

Eligibility criteria:
inclusion criteria: * histologically established metastatic (n+ or m1 = stage iv) or non-resectable soft tissue sarcoma· * grading ii/iii (guillou et al. j clin oncol 1997) * at least 1 measurable tumor parameter according to recist criteria * evidence of progression or primary manifestation (except osseous metastases and pleural effusion) * no previous radiation therapy of the only measurable lesion * no previous chemotherapy for metastatic disease; previous adjuvant chemotherapy is permitted if there was no progression of the disease within a period of 6 months * patients aged 60 years and beyond * written patient informed consent * ecog status 0-2 * granulocytes \>= 2 x 10\*\*9/l and thrombocytes \>= 100 x 10\*\*/l * serum creatinine, bilirubin \ 25 g/l * no severe comorbidity including psychosis or any previous history of uncontrolled cardiovascular disease * normal left-ventricular function by echocardiography or muga scan * no symptomatic cns metastases * willingness to receive regular follow-up examinations exclusion criteria: * histological grading of malignancy: g i * histology of gastrointestinal stromal tumor, chondrosarcoma, uterine stromal sarcoma, mesothelioma, neuroblastoma, osteosarcoma, ewing´s sarcoma/pnet, desmoplastic round cell tumor, embryonal rhabdomyosarcoma, alveolar soft tissue sarcoma * less than 5 years free of secondary malignancy except adequately treated carcinoma in situ (cis) of the cervix, the bladder urothelium, basal cell carcinoma, or adenoma of the colon including ptis, ptin
once-daily antiretroviral therapy in hiv-1 infected patients with cd4+ cell counts below 100 cells/mcl

Conditions: HIV Infections

Summary: there are few randomized clinical trials in advanced hiv patients. this is a multicenter, randomized, open clinical trial, comparing three parallel groups, to compare the immunological reconstitution and the virological efficacy and safety of three different combinations of antiretroviral therapy given once a day (qd): tenofovir plus emtricitabine plus either efavirenz, lopinavir-ritonavir or atazanavir-ritonavir during 96 weeks in advanced antiretroviral naïve hiv-1 infected patients with less than 100 cd4+ t-cells/mm3. primary endpoint is the median increase in cd4+ t-cell count at 48 weeks after starting haart.


Eligibility criteria:
inclusion criteria: * chronic hiv-1 infection * age 18 or more * antiretroviral-naive * baseline cd4+ count \<100 cels/mcl. * no mutations of drug resistance at baseline (m184v/i, k65r, resistance to efavirenz or 2 or more prams (l33i/f/v, v82a/f/l/t, i84v, l90m) * written informed consent exclusion criteria: * hypersensibility to study drugs. * pregnancy or breastfeeding * active oi requiring admission * active lymphoma or malignancy (kaposi sarcoma included) * cl creatinine below 30 ml/min. * liver failure * treatment with nephrotoxic drugs, immunomodulators, interleukine-2, systemic steroids or investigational products.

Keywords: advanced hiv-infected patients late presenters antiretroviral therapy immune reconstitution treatment naive
management of shoulder dystocia in flipped learning

Conditions: Shoulder Dystocia - Delivered

Summary: flipped learning is an innovative learning method in midwifery education. studies that apply this learning method together with shoulder dystocia training have not been found in the current literature. for this reason, the study was designed as a randomized controlled study to examine the effectiveness of the flipped learning technique in shoulder dystocia management using high-valid simulation in midwifery undergraduate education.

flipped learning is an innovative learning method in midwifery education. studies that apply this learning method together with shoulder dystocia training have not been found in the current literature. for this reason, the study was designed as a randomized controlled study to examine the effectiveness of the flipped learning technique in shoulder dystocia management using high-valid simulation in midwifery undergraduate education. hypotheses of the research; first hypothesis h1: the use of flipped learning model in midwifery education has an effect on midwifery students' shoulder dystocia knowledge levels. second hypothesis h1: the use of flipped learning model in midwifery education has an effect on midwifery students' levels of student satisfaction and self-confidence in learning. third hypothesis h1: the use of flipped learning model in midwifery education has an effect on midwifery students' pagana clinical stress levels.

Eligibility criteria:
inclusion criteria: * - agreeing to participate in the study, * being a 4th year student at the department of midwifery, exclusion criteria: * - refusing to participate in the study, * being a 1st, 2nd and 3rd year student in the midwifery department

Keywords: shoulder dystocia flipped learning midwifery student
safety and tolerability of pro-185

Conditions: Hyperemia Eye

Summary: phase i study to evaluate safety and tolerability of pro-185 (naphazoline/hypromellose) ophthalmic solution through evaluation of vital signs, ocular signs such as intraocular pressure, hyperemia and mydriasis and adverse events.

a total of 22 healthy volunteers will apply pro-185 ocular solution on both eyes qid (four times per day) for 8 days. the safety variables will include intraocular pressure, heart rate, systolic and diastolic blood pressure. tolerability variables will include: hyperemia, mydriasis, and expected and unexpected adverse events. the presence of any of these in ≤ 20% will deem pro-185 as safe and tolerable.

Eligibility criteria:
inclusion criteria: * being clinically healthy * having the ability to grant a signed informed consent * being able and willing to comply with the programmed visits, treatment plan and other procedures of this study. * age between 18 and 45 years * women in child-bearing age must assure the continuation (start ≥ 30 days previous to the signing of the icf) of a hormonal contraceptive method or a intrauterine device (iud) during the period of the study. * best corrected visual acuity equal of better than 20/30 in both eyes. * vital signs within normal ranges. * intraocular pressure ≥10 and ≤ 21 mmhg exclusion criteria: * using any kind of topic ophthalmic products * presenting allergies to naphazoline or the history of intolerance to nasal decongestants or ocular vasoconstrictive products. * history of diagnosis of suspicion of primary angle closure, primary angle closure or closed angle glaucoma. * history of iridotomies or waiting for this procedure to take place. * conjunctival hyperemia grade 3 or 4 according to efron scale. * ocular surface staining equal or greater to 3 in the sicca scale, for any eye. * using medications or herbology products, through any route of administration. * pregnant, breastfeeding or women who plan to get pregnant during the period of the study. * previous participation in any clinical study 90 days prior to the inclusion in the present study. * previous participation in this study. * using contact lenses which cannot be suspended during the period of this study. * history of any chronic illness, including diabetes and hypertension. * active inflammation or infection at the time of inclusion in this study. * unresolved lesions or traumas at the moment of inclusion in this study. * history of any kind of ocular surgery. * history of any surgical procedure, non-ophthalmologic, within the previous 3 months to the inclusion in this study.
(nod)-like receptors card domain-containing 4 levels in individuals with periodontitis

Conditions: Periodontitis; Gingivitis; Healthy

Summary: nlrc4, an inflammasome , is a cytosolic multiprotein complex involved in the initiation and modulation of the immune response. periodontitis is a chronic inflammatory disease that can start with localized inflammatory reactions created by the supporting tissues surrounding the teeth against microorganisms and then result in loss of teeth. it has been said that proinflammatory cytokines released in the microenvironment of periodontitis can increase the expression of nlrc4 inflammasome genes. the authors think that nlrc4 may play a role in the periodontitis. the aim of this study is to compare the nlrc4, il-1β and il-10 levels of healthy and periodontitis individuals.

periodontitis is a destructive chronic inflammatory disease that can start with localized inflammatory reactions created by the supporting tissues surrounding the teeth against microorganisms and then result in loss of teeth. inflammasomes are cytosolic multiprotein complex involved in the initiation and modulation of the immune response. interleukine -1β ( il-1β ) levels are associated with periodontal destruction in the pathogenesis of periodontal disease. interleukine-10 (il-10) has been reported to decrease periodontal disease progression rate. gingival crevicular fluid shows the cellular response in the periodontium. the most important host-related ingredients are inflammatory markers, including cytokines, enzymes, and interleukins. saliva analysis is used in the diagnosis of systemic conditions as well as in the diagnosis of oral pathologies. both nlrc4 and nlrp3 inflammasomes have been shown to play an important role in the induction of interleukin-1β secretion. periodontitis is induced by a complex microbial biofilm containing multiple gram-positive and gram-negative bacteria (including flagellate microorganisms) capable of activating a large number of nlrs. it has been said that proinflammatory cytokines released in the microenvironment of periodontitis can increase the expression of nlrc4 inflammasome genes. evidence on the role of inflammasomes in periodontal disease is still very poor. the aim of this study is to compare the nlrc4, il-1β and il-10 levels of healthy and periodontitis individuals.

Eligibility criteria:
inclusion criteria: * systemically healthy individuals who does not have a disease under treatment, individuals without regular systemic medication exclusion criteria: * smoking receiving periodontal treatment in the last 6 months pregnancy menopausal or menstrual period

Keywords: nlrc4
measurement of fibrinogen in patients with systemic inflammatory response syndrome (sirs), sepsis or chronicle liver disease on intensive care units (icu)

Conditions: SIRS; Sepsis; Liver Disease

Summary: in this study patients with 1. chronicle liver diseases * primary biliary cirrhosis * primary sclerosing cholangitis * alcoholic liver cirrhosis * hepatitis b or c * wilson's disease * cryptogenic cirrhosis 2. septic inflammatory response syndrome (sirs) * sepsis * septic shock 3. patients after lysis should be included blood samples will be gathered from the patients to measure fibrinogen with 5 different methods. the methods are: * clauss fibrinogen * pt-derived fibrinogen * immunoturbidimetric method * heat-precipitated fibrinogen * schulz fibrinogen the result of these tests will be correlated with laboratory values which are gathered in routine and the clinical outcomes.


Eligibility criteria:
inclusion criteria: * sirs * sepsis * septic shock * chronicle liver disease (meld-score \>10) * patient after lysis * patient agrees exclusion criteria: * no agreement

Keywords: fibrinogen sirs sepsis liver disease chronic liver disease septic shock