Kornimate/medical-research-clean huggingface dataset:
mucosal immunity against sars-cov-2 infection in covid-19 patients

Conditions: SARS-CoV-2 Infection

Summary: in this study nasal fluid (mucosal lining fluid), nose and throat swabs and blood was collected from patients with a confirmed sars-cov-2 infection who remained in home isolation, as well as from their household contacts who remained in home quarantine. on the collected nose and throat swabs a coronavirus pcr was performed. antibodies against sars-cov-2 were measured in the mucosal lining fluid and blood samples.

objective: primary objective: to analyse the development of mucosal immunity against sars-cov-2 in nasal fluid of covid-19 patients and their household contacts secondary objective(s): * to descriptively analyse the correlation of mucosal antibodies with viral diagnostics and disease symptoms * to determine the correlation between mucosal and serum antibody levels * to study the functionality of serum and mucosal antibodies study design: a single-site, observational, prospective cohort study among covid-19 patients and their household contacts study population: the study will be conducted among covid-19 patients with a laboratory-confirmed infection with sars-cov-2, as well as household contacts remaining in home quarantine at the same address, among secondary and tertiary hospital careworkers in the provinces of gelderland and noord-brabant in the netherlands. intervention (if applicable): n/a main study parameters/endpoints: mucosal antibodies: descriptive analysis of sars-cov-2 igg, iga, igm and igd concentrations in nasal fluid at the various collection moments. viral diagnostics: presence of sars-cov-2 in diagnostic specimens collected at inclusion visit. disease symptoms: presence of respiratory complaints in participants. serum antibodies: descriptive analysis of sars-cov-antibody concentrations in serum at day 28 antibody functionality: descriptive analysis of antibody functionality of serum and nasal fluid samples, including virus neutralization

Eligibility criteria:
inclusion criteria: * index case: * laboratory-confirmed case of sars-cov-2, with a positive indication for home isolation, and; * with at least 2 household contacts remaining in home quarantine at the same address * household contacts for each index case, the study will seek to recruit as many household contacts as possible in the same house as the index case. all household contacts of the index case remaining in home quarantine in the same house as the index case will be asked to participate. exclusion criteria: * covid-19 patients with a negative indication for home isolation, or having less than 2 household contacts remaining in home quarantine at the same address. for fingerprick blood collection, participants who have a medical indication against fingerprick blood collection will be excluded.

Keywords: sars-cov-2 household contacts mucosal immunitiy antibodies
assessment of flocked swabs for the identification of group a streptococcal pharyngitis

Conditions: Streptococcal Infection; Pharyngitis

Summary: this is a study to to compare traditional fibre wound swabs to more recently developed flocked swabs for the identification of group a streptococcal pharyngitis in children presenting to a children's emergency department.


Eligibility criteria:
inclusion criteria: * need for a bacterial throat culture

Keywords: flocked swab group a streptococcus pharyngitis
study of the effect of ivacaftor on lung clearance index in subjects with cystic fibrosis and the g551d mutation

Conditions: Cystic Fibrosis

Summary: the purpose of this study is to evaluate the effect of ivacaftor (vx-770) on lung clearance index (lci) in subjects aged 6 years and older with cystic fibrosis (cf) who have the g551d-cftr mutation on at least 1 allele.

currently, limited objective measures are available to quantify lung function in cf patients with mild lung disease. lung clearance index (lci) derived from inert gas multiple-breath washout (mbw) testing hold considerable promise to evaluate early lung disease as studies have detected abnormalities in a high percentage of cf patients with normal spirometry in both infants and children. this study explored the effect of ivacaftor on lci and the efficacy of ivacaftor on other clinical and biomarker endpoints of cf lung disease in subjects aged 6 years and older with cf who have the g551d-cftr mutation on at least 1 allele.

Eligibility criteria:
inclusion criteria: * male or female subjects with confirmed diagnosis of cf * must have the g551d-cftr mutation in at least 1 allele * fev1 \>90% of predicted normal for age, gender, and height exclusion criteria: * ongoing participation in another therapeutic clinical study or prior participation in an investigational drug study within the 30 days prior to screening * use of inhaled hypertonic saline treatment within 2 weeks of the period 1, day 1 visit
effect of fish oil on markers of the metabolic syndrome in overweight adolescent boys

Conditions: Metabolic Syndrome

Summary: the aim of the study is to investigate if dietary fish oil has a beneficial effect on blood pressure, insulin sensitivity, blood lipid profile, body composition and metabolic rate in healthy, but slightly overweight, teenage boys. we hypothesized that the n-3 long chain polyunsaturated fatty acids from fish oil might have greater effect during growth and development, as intervention trials studying the effect of fish oil on babies have shown greater effects than in adults.


Eligibility criteria:
inclusion criteria: * weight above the 90th percentile for height and age. exclusion criteria: * smoking, severe illnesses.

Keywords: blood pressure insulin sensitivity blood lipid profile
efficacy of qvar vs flovent diskus on small airways in poorly controlled asthmatic adolescents/adult patients

Conditions: Asthma

Summary: the primary objective of this study is to evaluate the effect of beclomethasone dipropionate hfa on small airways compared to fluticasone propionate powder for inhalation administered twice daily to poorly controlled asthmatics.


Eligibility criteria:
inclusion criteria: * poorly controlled asthma; * average use of over 2 puffs of albuterol per day in the previous 7 days or having symptoms of asthma on 5 of the last 7 days or awakening at night due to asthma at least once in the previous 7 days or having been treated with a course of oral or intravenous steroids at least once in the last 3 months. exclusion criteria: * subjects receiving escalating doses of immunotherapy, oral immunotherapy or short course (rush) immunotherapy for rhinitis; * requires beta-blockers, mao inhibitors, tricyclic antidepressants, oral or intranasal anticholinergics; * history and/or presence of any non-asthmatic acute or chronic lung disease, including but not limited to bronchitis, emphysema, active tuberculosis, bronchiectasis or cystic fibrosis; * history and/or presence of any clinically significant cardiovascular disease, clinically significant hepatic, renal, or endocrine dysfunction, stroke, uncontrolled diabetes, hyperthyroidism, convulsive disorders, neoplastic disease other than basal cell carcinoma, and significant psychiatric disease.

Keywords: poorly controlled asthma
ph ii cabazitaxel dd liposarcoma

Conditions: Dedifferentiated Liposarcoma

Summary: soft tissue sarcomas (sts) are a rare group of malignant heterogenous tumors (\> 50 histological subtypes, including liposarcoma, the commonest subtype of sts) with distinct genetic, pathological and clinical profiles, and varying patterns of tumor spread. the optimal cytotoxic treatment for this group of patients remains uncertain. single agents which are most effective include doxorubicin and ifosfamide, but objective response rates and progression-free survival times remain modest. there is clearly a need to improve treatment options for liposarcoma. eribulin, a antimicrotubule agent that targets the protein tubulin in cells, interfering with cancer cell division and growth , has demonstrated activity in sts. therefore, it is reasonable to explore whether other anti-microtubule agent like cabazitaxel have a role in sts. cabazitaxel has been shown to be a relatively safe, effective and tolerated. this drug has been approved by fda for prostate cancer. the main objective of this trial is to determine whether cabazitaxel demonstrate sufficient antitumor activity for liposarcoma.


Eligibility criteria:
inclusion criteria: * local diagnosis of dedifferentiated liposarcoma * age 18-75 yrs * who performance status 0-1 * radiological or histological diagnosis of inoperable locally advanced or metastatic disease, with evidence of disease progression within the past 6 months * clinically and/or radiographically documented measurable disease within 21 days prior to randomization.at least one site of disease must be unidimensionally measurable according to recist 1.1. * one previous chemotherapy regimen for locally advanced or metastatic dedifferentiated liposarcoma (this could include pre-operative chemotherapy for primary disease if subsequent complete resection was not achieved). * adequate haematological, renal and hepatic function * birth control measures * estimated life expectancy \> 3 months * related adverse events from previous therapies ≤ grade 1 * written informed consent exclusion criteria: * more than 1 prior molecularly targeted therapy (e.g. cdk4 inhibitor). any prior such therapy must be completed at least 4 weeks before randomization. * symptomatic cns metastases * previous encephalopathy of any cause or other significant neurological condition * concurrent or planned treatment with strong inhibitors or inducers of cytochrome p450 3a4/5 * pregnancy * inflammation of the urinary bladder (cystitis) * other invasive malignancy within 5 years (exceptions of non-melanoma skin cancer, localized cervical cancer, localized and presumably cured prostate cancer or adequately treated basal or squamous cell skin carcinoma) * significant cardiac disease * uncontrolled severe illness or medical condition, other than dd liposarcoma * hypersensitivity to taxanes or their excipients

Keywords: dedifferentiated liposarcoma cabazitaxel
bioequivalence study of the fixed dose combination of 5 mg saxagliptin/1000 mg metformin xr (manufactured in mt vernon, in) relative to 5 mg of onglyza and 2 × 500 mg glucophage xr

Conditions: Diabetes Mellitus

Summary: the purpose of this study is to demonstrate bioequivalence (be) of a 5 mg saxagliptin/1000 mg metformin extended release (xr) fixed-dose combination (fdc) tablet (manufactured in mt vernon, indiana) relative to a coadministered 5 mg onglyza tablet (saxagliptin, manufactured in mt vernon, indiana) and two 500 mg glucophage xr tablets (metformin xr, manufactured in evansville, indiana) in the fed state in healthy subjects.

this study is designed to evaluate if the fdc tablet of 5 mg saxagliptin/1000 mg metformin extended release (manufactured in mt vernon, indiana) is bioequivalent to the coadministered 5 mg saxagliptin tablet plus 2 x 500 mg glucophage xr tablets (manufactured in evansville, indiana)

Eligibility criteria:
inclusion criteria: * healthy male and female subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ecgs, and clinical laboratory determinations * body mass index (bmi) of 18 to 32 kg/m², inclusive * ages 18 to 55, inclusive exclusion criteria: * evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ecg or clinical laboratory determinations beyond what is consistent with the target population * major surgical procedure within 4 weeks prior to randomization * positive serology test for hiv, hbv or hcv * clinically significant history or presence of any of the following conditions: heart, liver, or kidney disease, neurologic or psychiatric disease * history of gastrointestinal disease within the past 3 months * any clinically significant medical condition that could potentially affect your participation in the study and/or personal well-being, as judged by the investigator * donated blood or blood products to a blood bank, blood transfusion or participated in a clinical study (except a screening visit) requiring withdrawal of blood within 4 weeks prior to randomization * unable to tolerate oral and/or intravenous (iv) medications * unable to tolerate the puncturing of veins for drawing of blood * known allergy or hypersensitivity to any component of the study medication * history of any significant drug allergies (such as anaphylaxis or hepatotoxicity) * used any prescription drugs or over the counter products to control acid (for example, prevacid, mylanta or rolaids) within 4 weeks prior to randomization * used any other drugs including over the counter medications and herbal preparations within 1 week prior to randomization * taken any investigational drug or placebo (inactive drug) within 4 weeks prior to randomization
efficacy and safety of leo 43204 in field treatment of actinic keratosis on balding scalp including 12-month follow-up

Conditions: Actinic Keratosis

Summary: the objective of the trial is to compare the short term efficacy of leo 43204 gel with vehicle gel in ak on the balding scalp when applied topically once daily for 3 consecutive days as field treatment


Eligibility criteria:
inclusion criteria: * subjects with 5 to 20 clinically typical, visible and discrete aks within a treatment area of sun-damaged skin on the full balding scalp (the balding part of the scalp should be greater than 25 cm2 (4 in2) and up to approximately 250 cm2 (40 in2) * subjects with minimum 3 clinically typical, visible and discrete aks within a tracking area of 50 cm2 (8 in2). the tracking area must be within the treatment area exclusion criteria: * location of the treatment area (balding scalp) within 5 cm of an incompletely healed wound or within 5 cm of a suspected bcc or scc * treatment with ingenol mebutate gel in the treatment area within the last 12 months * lesions in the treatment area that have: atypical clinical appearance (e.g. hyperthrophic, hyperkeratotic or cutaneous horns) and /or, recalcitrant disease (e.g. did not respond to cryotherapy on two previous occasions) * history or evidence of skin conditions other than the trial indication that would interfere with the evaluation of the trial medication (e.g. eczema, unstable psoriasis, xeroderma pigmentosum)
phase iii trans-arterial chemo-embolization (tace) adjuvant hcc

Conditions: Hepatocellular Carcinoma

Summary: the purpose of this study is to compare the overall survival (os) of hcc patients who receive brivanib as adjuvant treatments to tace therapy, with the os of hcc patients who receive matched placebo with tace therapy.


Eligibility criteria:
for more information regarding bms clinical trial participation, please visit www.bmsstudyconnect.com. inclusion criteria: * patients with diagnosis of hepatocellular carcinoma * cirrhotic status of child-pugh class a or b with a score of 7 * ecog performance status of 0 or 1 * adequate hematologic, hepatic, and renal function exclusion criteria: * prior use of any systemic anticancer chemotherapy, immunotherapy, investigational or molecular targeted agents for hcc * history of cardiac disease * active and untreated hepatitis b * inability to swallow tablets or untreated malabsorption syndrome * history of human immunodeficiency virus (hiv) infection

Keywords: hcc
comparison of multiple exercise trainings in chronic respiratory disease

Conditions: Chronic Pulmonary Disease

Summary: the present study aims to investigate the effect of different exercise training in patients with chronic respiratory disease.

background： chronic respiratory and chronic obstructive pulmonary disease is the one of the major causes of global morbidity and mortality. patients with chronic respiratory disease often experience exercise limitation and physical inactivity due to muscular weakness and severe dyspnea. symptoms of copd may contribute to activity restriction, deconditioning, and exercise intolerance. pulmonary rehabilitation has been demonstrated to improve clinical outcomes and exercise capacity in patients with chronic respiratory disease. however, the optimal exercise training modality is remaining unclear. study design： this is a one-year, single-centre, prospective randomized controlled trial methods： the investigators expected a total of 60 participants were be enrolled, then randomly assigned into three groups (control group, experimental-1, and experimental-2). all participants will receive a graded exercise test, then followed a 9-weeks of exercise training. after 9-weeks of exercise training, the maximal oxygen consumption will be analyzed as a primary outcome of this study. physiological parameters, hemodynamic outcome, respiratory function, and strength of lower limb muscle will be recorded. effect： after 9 weeks' exercise training, vo2 will significantly improve in eccentric cycling exercise groups, furthermore, heart rate and perceived exertion will be lower in the eccentric cycling exercise combined with helmet ventilation. key words： pulmonary rehabilitation; eccentric cycling exercise; helmet ventilation; chronic respiratory disease

Eligibility criteria:
inclusion criteria: * age between 20 and 80 years * diagnosed with chronic respiratory diseases * having undergone pulmonary rehabilitation for more than 3 months exclusion criteria: * existing of tracheostomy * those who use oxygen therapy or ventilator at home * severe left heart failure (nyha iii-iv) * neuromuscular disease * acute exacerbation within the past three months * those who are unable to cooperate with the cardiopulmonary exercise test

Keywords: pulmonary rehabilitation eccentric cycling exercise helmet ventilation chronic respiratory disease
safety and efficacy of mk-8457 and methotrexate (mtx) in participants with active rheumatoid arthritis despite mtx therapy (p08683, mk-8457-008)

Conditions: Rheumatoid Arthritis (RA)

Summary: the purpose of this study is to assess the safety and efficacy of mk-8457 + methotrexate (mtx) in participants with active rheumatoid arthritis (ra) despite mtx therapy. the primary hypothesis is that at least 1 dose of mk-8457 + mtx will be superior to placebo + mtx as measured by the percentage of participants who achieve american college of rheumatology 20 (acr 20) response after 12 weeks of treatment.

in base study phase iia, participants were to receive blinded mk-8457 100 mg or matched placebo for up to 24 weeks. at week 12 and 18 of phase iia, efficacy evaluation was conducted to assess eligibility for early escape, defined as \<20% reduction in both tender and swollen joint counts. the study plan included base study phase iib in which dose range finding or dose-response was to be evaluated, depending on the outcome of phase iia. participants who completed phase iia or phase iib and those eligible for early escape could enroll in period 3, a 2-year safety extension. all participants must have been treated with mtx for at least 3 months prior to screening and have been receiving a stable dose of mtx for at least 4 weeks prior to screening.

Eligibility criteria:
inclusion criteria: * diagnosis of rheumatoid arthritis for at least 6 months prior to screening * active rheumatoid arthritis as defined by the presence of \>= 6 swollen joints (of 66 count) and \>= 6 tender joints (of 68 joint count) * c-reactive protein blood level \>0.9 mg/dl * anti-citrullinated protein antibody positive and/or rheumatoid factor positive at screening * american college of rheumatology functional class i, ii, or iii * received methotrexate for a minimum of 3 months prior to screening with a regionally appropriate stable weekly dose for at least 4 weeks prior to screening * if using oral corticosteroids, the participant must be on a stable dose of 10 mg prednisone * no history of either untreated, latent, or active tuberculosis prior to baseline * participants of reproductive potential must agree to remain abstinent or use 2 acceptable methods of birth control exclusion criteria: * presence of inflammatory disease other than rheumatoid arthritis, including but not limited to psoriatic arthritis, ankylosing spondylitis, systemic lupus erythematosus, or lyme disease * positive hepatitis b surface antigen or hepatitis c test result or the presence of human immunodeficiency virus (hiv) infection * hiv positive * user of recreational or illicit drugs or has had a history (within the previous 2 years) of drug or alcohol abuse or dependence * females of childbearing potential who are pregnant, intend to become pregnant, or are lactating; * severe opportunistic infection within 6 months prior to study start.
feasibility of ambulatory surgery for early breast cancer

Conditions: Early Breast Cancer; Psychosocial Wellbeing; Ambulatory Surgery

Summary: the aim was to assess the patient compliance and medical and psychosocial effects of same day hospital discharge after breast conserving surgery and sentinel node biopsy only.

the patients with small breast tumours (\<2 cm)and clinically node negative disease, were randomized to receive breast conserving surgery and sentinel node biopsy as ambulatory surgery or inpatient-surgery.complication rate, patient satisfaction and psychosocial outcomes were compared. the psychosocial effects of the treatment mode on their spouses were recorded as well.

Eligibility criteria:
inclusion criteria: * breast cancer \< 2cm * clinically node negative * asa i-ii exclusion criteria: * axillary clearance performed * asa iii-iv * no adult companion at home

Keywords: early breast cancer surgery psychosocial wellbeing ambulatory surgery
effect of korean red ginseng on central blood pressure in patient with essential hypertension

Conditions: Hypertension

Summary: the purpose of this study is to determine korean red ginseng (krg)treatment could decrease central blood pressure in subjects with hypertension.

participants with hypertension who were treated with antihypertensive agents were randomly assigned to an active (krg 2 g/day) or a placebo treatment group in a double-blind cross over manner. participants were not allowed to change their antihypertensive medications except safety issue. brachial systolic bp (sbp), diastolic bp (dbp), central sbp and dbp will measured at baseline,at 2 and 4 months. efficacy and safety data will be monitored by daegu catholic university medical center institutional review board and reported to the korean ginseng society.

Eligibility criteria:
inclusion criteria: * essential hypertension * diastolic blood pressure 100 mmhg or less and systolic blood pressure 160 mmhg or less exclusion criteria: * secondary hypertension * serum creatinin above 1.5 mg/dl * aspartate aminotransferase(ast) and alanine aminotransferasealt above two times upper normal limits * uncontrolled diabetes (hb a1c \< 9%) * acute myocardial infarction or coronary artery disease intervention within six months * moderate to severe congestive heart failure * hiv positive * immunocompromized host * allergy to korean red ginseng * pregnancy or plan to pregnancy * alcohol or drug abuse * attend to other clinical trial within 12 weeks

Keywords: blood pressure, ginseng