Kornimate/medical-research-clean huggingface dataset:
trial to evaluate efficacy and safety of lenabasum in cystic fibrosis

Conditions: Cystic Fibrosis

Summary: this is a phase 2 multicenter, double-blind, randomized, placebo-controlled study assessing the efficacy and safety of lenabasum for the treatment of cystic fibrosis in patients 12 years of age or older. approximately 415 subjects will be enrolled in this study at about 100 sites in north america, and europe. the planned duration of treatment with study drug is 28 weeks. study drug will be lenabasum 20 mg bid, lenabasum 5 mg bid, and placebo in a 2:1:2 ratio.


Eligibility criteria:
inclusion criteria: 1. ≥ 12 years of age at the time informed consent/ assent is signed. 2. weight ≥ 40 kg. 3. fev1 ≥ 40% predicted and \< 100% predicted in the last 12 months. 4. physician-initiated treatment with an iv antibiotic 2 or 3 times in the last 12 months for a new pex or physician-initiated treatment with an iv antibiotic 1 time in the last 12 months plus physician-initiated treatment with oral antibiotic(s) 1 or more times in the past 12 months for a new pex. exclusion criteria: 1. severe or unstable cf at screening or visit 1. 2. any of the following values for laboratory tests at screening: 1. a positive pregnancy test. 2. hemoglobin \< 10 g/dl in males and \< 9 g/dl in females. 3. neutrophils \< 1.0 x 10\^9 /l. 4. platelets \< 75 x 10\^9/l. 5. creatinine clearance \< 50 ml/min according to modification of diet in renal disease (mdrd) study equation. 6. serum transaminases \> 2.5 x upper limit of normal. 3. any medical condition or concurrent medical therapies at screening or visit 1 that may put the subject at greater safety risk, influence response to study drug or interfere with study assessments.

Keywords: pulmonary exacerbation, lenabasum, jbt-101
radiotherapy or observation of liver metastases in small cell lung cancer

Conditions: Radiotherapy; Complications

Summary: the aim of this randomized study is to investigate local tumor control,survival outcomes and complications on patients of liver metastasis in small cell lung cancer.

small cell lung cancer (sclc) is a kind of disease with high degree of malignancy and poor prognosis.based on the effectiveness of systemic chemotherapy, the treatment of primary lesions and whole brain radiotherapy can bring survival benefits to patients with extensive stage small cell lung cancer.patients with liver metastasis have a worse prognosis than those with other organ metastases.local radiotherapy for patients with liver metastasis may have a better prognosis.however, clinical data of the safety and efficacy of whole liver radiotherapy for liver metastasis are still lacking.the purpose of this prospective study is to evaluate the safety, efficacy, and tolerability of liver metastatic radiotherapy in small cell lung cancer (sclc).

Eligibility criteria:
inclusion criteria 1. informed consent (radiation, medication) before treatment; 2. age 18 to 70 years old,regardless of gender; 3. initial sclc confirmed by histopathological or cytological examination; 4. metastatic lesions in the distant area: included liver metastasis； 5. physical status score ecog: 0 to 2； 6. the expected survival time is more than 3 months; 7. bone marrow function:hemoglobin(hgb)\>90g/l,platelet(plt)\>100×109/l,neutrophil cell(wbc)\>1.5×109/l(\*normal value); 8. liver function:alanine aminotransferase(alt) and aspertate aminotransferase(ast)\<1.5 times of the upper limit of normal(uln);total bilirubin \<1.5uln; 9. renal function:serum creatinine was lower than 1.5uln,and the endogenous creatinine clearance rate(ccr) is higher than 55ml/min; 10. initial treatment (previously did not receive any thoracic radiotherapy or surgery). exclusion criteria: 1. patients with history of mental illness; 2. patients combined with other malignancies; 3. active period of disease caused by bacteria, fungi or viruses; and these severe infection requiring intravenous antibiotics,antifungal or antiviral therapy; 4. patients with serious cardiovascular disease ,including uncontrolled hypertension, unstable angina,history of myocardial infarction within the past 12 months,and severe arrhythmias. 5. patients with poorly controlled diabetes who are judged to be unfit for chemotherapy by doctors. 6. history of hepatitis and cirrhosisi ; 7. pregnant, lactating patients; 8. patients with poor compliance； 9. researchers believe that it is not appropriate to participate in this test.

Keywords: radiotherapy;liver metastases;small cell lung cancer;
physiology of cough in asthma: comparison of sensory-mechanical responses to mannitol and methacholine challenge tests

Conditions: Asthma; Cough Variant Asthma

Summary: cough is a common, disruptive and at times disabling symptom which often prompts patients to seek medical attention. determining the cause(s) of chronic cough can be challenging, and costly. asthma and other airway disorders are among the most common causes of chronic cough; and cough can be the sole symptom of asthma. little is known about why some patients with asthma primarily cough and do not develop the other symptoms of asthma such as shortness of breath or wheeze. improved understanding of the reasons for these different manifestations may lead to new and more effective treatment strategies. we have notices differences in pressure measurements inside the chest in patients who mostly cough during induced bronchoconstriction, which might be part of the explanation for varying symptoms. this study will compare lung mechanical responses during methacholine and mannitol-induced induced airway narrowing between typical asthma, cough variant asthma (cva) and an airway inflammatory disorder that is not asthma.the purpose of this research is to explore the pathophysiology and sensory-mechanics of cough in individuals with asthma, cva and methacholine-induced cough but normal airway sensitivity using mannitol and high-dose methacholine bronchoprovocation testing.


Eligibility criteria:
inclusion criteria: 1. subjects with asthma or suspected cva who have previously participated in or who have expressed interest in participating in studies will be invited to participate in the study. previous treatment with inhaled or systemic corticosteroids is not an exclusion criterion, but medication use will be recorded and examined in the analysis. exclusion criteria: 1. an exacerbation necessitating any alteration in medication, emergency department visit or hospitalizations within the previous 4 weeks; 2. inability to perform acceptable quality spirometry; 3. medical contraindications to methacholine challenge testing 35, including: 1. severe airflow limitation (fev1 \<50% predicted or \<1.0 l); 2. heart attack or stroke in last 3 months; 3. uncontrolled hypertension, systolic bp \> 200 or diastolic bp \> 100; 4. known aortic aneurysm; 5. moderate airflow limitation \< 60% predicted or \<1.5 l); 6. inability to perform acceptable quality spirometry; 7. current use of cholinesterase inhibitor medication (for myasthenia gravis); and 8. pregnant or nursing mothers. 4. smoking history in excess of 10 pack years; 5. medical contraindications to mannitol challenge testing, including: 1. aortic or cerebral aneurysm; 2. uncontrolled hypertension; and 3. myocardial infarction or a cerebral vascular accident in the previous six months). 6. women who are pregnant or breastfeeding because the effects of a possible hyperresponsiveness reaction to mannitol in mothers and/or fetuses are unknown and many compounds are excreted in human milk therefore caution should be taken.

Keywords: asthma cough variant asthma mannitol methacholine cough hypersensitivity
thrombohemorrhagic complications of covid-19

Conditions: COVID-19 (Coronavirus Disease 2019)

Summary: the nature of the planned study: the topic is of an applied nature and is aimed at improving the results of comprehensive treatment of patients with covid-19, the course of whose disease was complicated by thrombotic or hemorrhagic catastrophes. it is planned to analyze the results of treatment of this category of patients based on the work of several centers that provided surgical care to patients with covid-19 during the pandemic (8 cities). as a result of the analysis, it is planned to develop algorithms for the prevention and treatment of thrombotic and hemorrhagic complications in patients with covid-19. the proposed study will be multicenter, cohort, retrospective. the purpose of the study: improvement of treatment results in covid-19 patients with thrombotic or hemorrhagic complications scientific novelty: for the first time, as a result of a multicenter study, it is expected to identify the most effective approach to the treatment and prevention of thrombotic and hemorrhagic complications in patients with covid-19. for the first time, it is planned to develop and put into practice algorithms for the application of the most effective methods of treatment and prevention of thrombohemorrhagic complications of covid-19.


Eligibility criteria:
inclusion criteria: * patients with thrombohemorrhagic complications who were treated in a covid hospital exclusion criteria: * cancer patients * patients who had thrombohemorrhagic disorders before admission to the hospital * pregnant women * patients receiving routine anticoagulant and antiplatelet therapy before admission to the hospital
phase ii study of growth hormone in children with cystic fibrosis

Conditions: Cystic Fibrosis

Summary: objectives: i. determine the effect of growth hormone on height, height velocity, body weight, and lean body mass in patients with cystic fibrosis. ii. determine the effect of growth hormone on pulmonary function in these patients. iii. determine the impact of this drug on the quality of life in these patients. iv. determine if the clinical response from this drug is sustained in these patients.

protocol outline: this is a randomized, multicenter study. patients are randomized to 1 of 2 treatment arms. arm i: patients receive growth hormone subcutaneously (sc) daily for 1 year during the first year only. arm ii: patients receive growth hormone sc daily for 1 year during the second year only. quality of life is assessed at baseline and then every 6 months for 2 years.

Eligibility criteria:
protocol entry criteria: --disease characteristics-- * diagnosis of prepubertal cystic fibrosis * no colonization by burkholderia cepacia --prior/concurrent therapy-- * no prior or concurrent insulin requirement --patient characteristics-- * hematopoietic: no hematologic disease * hepatic: no liver disease * renal: no kidney disease * pulmonary: must be able to perform pulmonary function testing * other: no history of diabetes must be less than 25% of normal height and/or weight for age and sex

Keywords: cardiovascular and respiratory diseases cystic fibrosis disease-related problem/condition genetic diseases and dysmorphic syndromes quality of life rare disease
a phase 3 study of sym-1219 treatment of women and post-menarchal adolescent girls with bacterial vaginosis

Conditions: Bacterial Vaginosis

Summary: the purpose of this clinical trial is to test the safety and efficacy of the oral investigational new drug, sym-1219 for the treatment of bacterial vaginosis.


Eligibility criteria:
inclusion criteria: * are premenopausal adult females or post menarchal adolescent girls ≥12 years of age in good general health * have a clinical diagnosis of bacterial vaginosis, defined as having all of the following criteria: * off-white (milky or gray), thin, homogeneous vaginal discharge * vaginal ph ≥ 4.7 * presence of clue cells of ≥ 20% of the total epithelial cells on microscopic examination of the vaginal saline wet mount * a positive 10% koh whiff test * have a gram stain slide nugent score ≥ 4 at the baseline visit (day 1) exclusion criteria: * are pregnant, lactating, or planning to become pregnant during the study * are menstruating or have vaginal bleeding at the baseline visit (day 1) * are suspected clinically (or confirmed diagnostically) of having alternative causes of vaginal symptoms including candidiasis, chlamydia trachomatis, trichomonas vaginalis, neisseria gonorrhoeae or herpes simplex * have received antifungal or antimicrobial therapy (systemic or intravaginal) within 14 days prior to the baseline visit (day 1)
immunological characteristics of preclinical ibd

Conditions: Crohn Disease; Ulcerative Colitis; IBD

Summary: the purpose of this study is to evaluate disease progression, in terms of development of symptomatic disease and complications associated with ibd (e.g. fistula, abscess, stricture).

this is a prospective, observational, multicenter, collaborative research project that will explore the earlier stages of ibd, before the onset of the first symptoms of the disease. this novel approach constitutes an innovative strategy on the research on the natural history of the disease. the study will be carried out based on colorectal cancer screening colonoscopies, recruiting all patients with a new diagnosis of ibd in this setting. these patients will undergo follow-up visits every 6 months for 10 years and the clinical information will be enriched with longitudinal multi-omic analyses. two additional control groups will be identified, including patients with new-onset symptomatic ibd in the last 3 months and healthy controls (with normal screening colonoscopy).

Eligibility criteria:
inclusion criteria patients from cohort a will be included if they fulfill all the following inclusion criteria: * male or female ≥18 years of age at baseline. * new diagnosis of ibd during a crc screening colonoscopy, based on the criteria from the european crohn's and colitis organization (33, 34). * presence of a chronic inflammatory infiltrate and histological diagnosis compatible with ibd. * the patient must be asymptomatic at diagnosis and without previous symptoms suggestive of ibd. * time interval between the index colonoscopy and the baseline visit up to 3 months. patients from cohort b will be included if they fulfill all the following inclusion criteria: * male or female ≥18 years of age at baseline. * recent diagnosis of ibd, with \<3 months from symptoms onset. * time interval between the index colonoscopy and the baseline visit up to 3 months. patients from cohort c will be included if they fulfill all the following inclusion criteria: * male or female ≥18 years of age at baseline. * no endoscopic signs of ibd after a complete ileo-colonoscopy within the crc screening program. * time interval between the index colonoscopy and the baseline visit up to 3 months. exclusion criteria patients from cohort a will be excluded if they fulfill any the following exclusion criteria: * identification of any enteropathogen in the stool culture. * isolated findings of acute inflammatory infiltrate without signs of chronicity. * previous or current diagnosis of microscopic colitis. * alteration in biomarkers in blood or stool will not constitute an exclusion criterion. patients from cohort b will be excluded if they fulfill any the following exclusion criteria: - previous use of immunomodulators or biologics for any condition. patients from cohort c will be excluded if they fulfill any the following exclusion criteria: * any gastrointestinal symptoms at baseline. * previous use of immunomodulators or biologics for any condition.
a nis registry of the prospective structured care in acute coronary syndrome

Conditions: Acute Coronary Syndrome

Summary: the purpose of the study is to analyse patient's acceptance and willingness to participate in a structured care program (scp) over 12 months following hospital discharge after acute coronary syndrome (acs) index event.

proacor: prospective structured care in acute coronary syndrome registry

Eligibility criteria:
inclusion criteria: * patients hospitalized because of acs (st segment elevation myocardial infarction (stemi)), non-st elevation myocardial infarction (nstemi) unstable angina (ua)) and planned to be discharged alive soon. exclusion criteria: * myocardial infarction (ua, stemi and nstemi) precipitated by or as a complication of surgery, trauma, or gastrointestinal bleeding or post- percutaneous coronary intervention (pci). * myocardial infarction (ua, stemi and nstemi) occurring in patients already hospitalized for other reasons. * presence of any condition/circumstance which in the opinion of the investigator could significantly limit the complete follow up of the patient (e.g. tourist, non-native speaker or does not understand the local language, known diagnosed psychiatric illness

Keywords: acs patients participating in a scp qol after acs asc patients's needs
predictive factors covid-19 patients

Conditions: covid19

Summary: this is a monocentric retro-prospective observational study that will be conducted on all covid19 positive patients hospitalized at the s. gerardo hospital in monza.

background: the severe acute respiratory syndrome-coronavirus-2 (sars-cov-2) pandemic is severely testing the health systems of the most advanced countries. clinicians are faced with a new pathology of an emerging virus. there is therefore an urgent need to collect real-time clinical data that informs about outcome predictive variables. furthermore, there are currently no antiviral drugs approved for the treatment of sars-cov-2 infection, off-label therapies are being used with drugs already in use for other pathologies that have shown some efficacy in vitro, and some treatments obtained for compassionate use with other drugs that are being tested. it is more than ever necessary to collect clinical practice data both retrospectively on the work done so far, and in a longitudinal perspective, and analyze them quickly to optimize current treatments and define protocols for the future. having a good clinical data base also offers the possibility of collaborating with numerous international networks on translational research, which aims to correlate clinical data with virological and immunological data, aimed at the rapid identification of possible specific viral virulence factors, or particular immune structures of the guests who once again define the final clinical outcome. study design: all covid19 positive patients admitted to san gerardo hospital will be enrolled in the study. after patient signs the informed consent, the following data will be collected: * birth data * sex * demographic data * comorbidity * blood chemistry data at the entrance a series of variables will then be collected relating to the treatment procedure, the therapies, the team's choice to maximize the care ceiling in the individual patient and the entire clinical study of the patient. statistical analisys: central tendency and dispersion measurements will be used for descriptive analysis of continuous variables while absolute and relative frequencies will be used to describe categorical variables.

Eligibility criteria:
inclusion criteria: * patients 18 years old or above * diagnosis of sars-cov-2 pneumonia exclusion criteria: * explicit refusal to participate in the study

Keywords: coronavirus sars-covid-2 coronavirus infection
phase i/ii study of z-208 in advanced hepatocellular carcinoma (hcc)

Conditions: Advanced Hepatocellular Carcinoma

Summary: this phase i/ii is studying the side effect and best dose of z-208 for patients with advanced hepatocellular carcinoma

this is an open-label, dose-escalation study phasei treatments repeats for 28 days for 1 course in the unacceptable toxicity cohort of 3 patients receive escalating doses of z-208 until the maximum tolerated dose (mtd) is determined. the mtd is defined as the dose preceding that at which 1 of 3 patients experience dose-limiting toxicity. phaseii treatments repeats for 28 days for 6 courses until absence of disease progression or unacceptable toxicity.

Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed hepatocellular carcinoma * at least one measurable site of disease according to recist criteria that has not been irradiated. * child-pugh classification a \& b * ecog performance status of 0-1 * life expectancy is more than 90 days * adequate organ function as defined by the following criteria, hemoglobin ≥ 8.0 g/dl wbc ≥ 3,000/mm\^3 \<12,000/mm\^3 absolute neutrophil count ≥ 1,500/mm\^3 platelet count ≥ 50,000/mm\^3 ast and alt ≤ 5 times upper limit of normal (uln) albumin ≥ 2.8 g/dl bilirubin ≤ 2.0 mg/dl creatinine ≤ 1.5 times uln * must provide written informed consent prior to the implementation of any study assessment or procedures exclusion criteria * patients received treatment with any of the following within the specified timeframe;any surgical procedure, radiofrequency ablation, intraarterial chemotherapy within 30 days prior to signing the icf, any treatment with transfusion, albumin preparation, g-csf within 15 days prior to signing the icf * cns involvement must have completed appropriate treatment * prior deep vein thrombosis * has ascites, pleural effusions or pericardial fluid refractory * active clinically serious infection excluding chronic hepatitis * any history of deep vein thrombosis, pulmonary embolism, myocardial infraction, cerebrovascular accident * allergy or hypersensitivity to vitamin a * women who are pregnant or breast feeding

Keywords: z-208
closed window vs. open window technique in management of palatally impacted canines

Conditions: Impacted Canine

Summary: in this investigation the investigators would like to find out which of two commonly used techniques of management of palatally impacted canines: closed-window (cwt) or open-window (owt), produces more favorable outcome.

rationale and objective: two techniques for exposing palatally impacted canines are routinely used, the closed window technique (cwt) and the open window technique (owt). to our knowledge, there is no evidence-based information that would suggest, which of the two techniques results in a better outcome. our null hypothesis is that there is no difference in the outcome of exposed impacted maxillary canines after cwt or owt. study design: a randomized clinical multicentre trial with a two-group design. the randomization is by canine, not by patient. study population: the case group consists of healthy persons of 11-17 years old who have unilateral palatally impacted canines. intervention: one group will be treated with the cwt and the other group with the owt. main study parameters/endpoints: the main outcome measure will be the total duration of treatment (including also orthodontic treatment) with two techniques of management of impacted canines. the secondary outcome measures will be: (1) duration of surgical procedure, (2) patients perception of pain and recovery after surgery, (3) burden of care, (4) cost-effectiveness, (5) quality of life and satisfaction with treatment, (6) degree of root resorption of the lateral incisor, (7) periodontal status of impacted canine and adjacent teeth, (8) esthetic outcome, (9) need for endodontic treatment of the impacted canine or adjacent lateral incisor, (10) occlusal outcome (evaluated with par index). nature and extent of the burden and risks associated with participation, benefit and group relatedness: the cwt and owt are current treatment techniques. to our knowledge, there is no sound scientific information available on which to base a treatment decision. the burden of each treatment is for the patient the same. routine pre- and post-treatment records will be taken. the extra burden for the patients participating in the trial will be records and questionnaires during treatment and long-term

Eligibility criteria:
inclusion criteria: * healthy boys and girls aged 11 to 17 years * unilaterally palatally impacted canine * canine axis \> 100 to the midline measured on an orthopantomogram exclusion criteria: * dental abnormalities (hyperdontia, hypodontia, etc.) * previous dental or facial trauma * congenital craniofacial disorder

Keywords: impaction impacted canine palatally open window closed window management