Kornimate/medical-research-clean huggingface dataset:
efficacy and safety of dupilumab in participants ≥12 to <18 years of age, with moderate-to-severe atopic dermatitis

Conditions: Moderate-to-Severe Atopic Dermatitis; Dermatitis, Dermatitis Atopic; Eczema, Skin Diseases, Skin; Diseases Genetic, Genetic; Diseases Inborn, Skin; Disease, Eczematous Skin; Hypersensitivity, Immediate; Hypersensitivity, Immune System Diseases; Dermatitis, Atopic

Summary: the primary objective of the study was to demonstrate the efficacy of dupilumab as a monotherapy in participants ≥12 years to \<18 years of age with moderate-to-severe atopic dermatitis (ad). the secondary objective of the study was to assess the safety of dupilumab as a monotherapy in participants ≥12 years to \<18 years of age with moderate-to-severe ad.


Eligibility criteria:
inclusion criteria: * male or female ≥12 to \<18 years of age at time of screening visit * diagnosis of ad according to the american academy of dermatology consensus criteria at screening visit * iga ≥3 at screening and baseline visit * easi ≥16 at the screening and baseline visit * baseline pruritus nrs average score for maximum itch intensity ≥4 * ≥10% bsa of ad involvement at the screening and baseline visits * with documented recent history (within 6 months before the screening visit) of inadequate response to topical ad medication(s) or for whom topical treatments is medically inadvisable exclusion criteria: * participation in a prior dupilumab clinical study * treatment with topical corticosteroids (tcs) or topical calcineurin inhibitors (tci) within 2 weeks before the baseline visit * having used immunosuppressive/immunomodulating drugs within 4 weeks before the baseline visit * body weight \<30 kg at baseline * active chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiprotozoals, or antifungals within 2 weeks before the baseline visit * known or suspected immunodeficiency, known history of human immunodeficiency virus (hiv) infection or hiv seropositivity at the screening visit, established diagnosis of hbv infection or hbv seropositivity at screening, established diagnosis of hcv infection or hcv seropositivity at screening * history of malignancy before the baseline visit * diagnosed active endoparasitic infections or at high risk of these infections * patient is female who is pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study * patient is female of childbearing potential and sexually active, who is unwilling to use adequate methods of contraception throughout the duration of the study and for 120 days after the last dose of study drug other protocol-defined inclusion/exclusion criteria may apply
va-sense - bacterial vaginosis once a week screening and treatment to reduce infective complications, abortion and preterm delivery in pregnant women with previous preterm delivery

Conditions: Vaginal Infections; Bacterial Vaginosis; Late Miscarriage; Preterm Birth; Preterm Premature Rupture of Membranes

Summary: the purpose of this study is to determine whether screening of pregnant women with history of previous preterm delivery, once a week, for bacterial vaginosis using va-sense, and treatment of positive women will reduce the risk of spontaneous preterm birth. we will compare between the effectiveness of once a week screening and once during pregnancy screening.


Eligibility criteria:
inclusion criteria: 1. pregnant subjects, aged 18-50 years, pregnancy week 10 or less or 20 or less, with history of previous preterm delivery. 2. subject is ready to sign an informed consent form. exclusion criteria: 1. subject with ruptured membranes. 2. subject with signs and symptoms of bacterial vaginosis or trichomoniasis infections. 3. subject with blood in her vaginal secretions. 4. subject is currently participating in another clinical study. 5. subject is unable or unwilling to cooperate with study procedures.

Keywords: bacterial vaginosis screening abortion preterm delivery
phase 1 study to evaluate the effect of ds-8201a on the qt/qtc interval and pharmacokinetics in her2-expressing breast cancer

Conditions: Malignant Neoplasm of Breast

Summary: this study will look at the effect on the qtc interval and pharmacokinetics after multiple dosing in subjects with her2-expressing metastatic and/or unresectable breast cancer.


Eligibility criteria:
inclusion criteria: * has a pathologically documented unresectable or metastatic breast cancer with her2 expression (immunohistochemistry \[ihc\] 3+, ihc 2+, ihc 1+ and/or in situ hybridization \[ish\] +) that is refractory to or intolerable with standard treatment, or for which no standard treatment is available * has a left ventricular ejection fraction (lvef) ≥ 50% * has an eastern cooperative oncology group performance status (ecog ps) score of 0 or 1 exclusion criteria: * has a medical history of myocardial infarction within 6 months before enrollment * has a medical history of ventricular arrhythmias, other than rare occasional premature ventricular contractions * has uncontrolled or significant cardiovascular disease

Keywords: her2 breast cancer oncology antibody drug conjugate adc
bronchial allergen provocation tests in asthmatics in guangzhou

Conditions: Allergic Asthma

Summary: the purpose of this study is to establish the methodology of bronchial provocation tests with house dust mites in china, and to evaluate its safety and effects on upper and lower airways inflammation.

after screening,each participant undergo baseline lung function test,airway inflammation evaluation (blood and sputum eosinophils count,interleukin-13 (il-13),feno)and airway responsiveness tests(methacholine bronchial provocation,nasal histamine provocation). on the second day,the participant undergo bronchial house dust mites challenge tests. on the third day,the participant undergo the lung function test,airway inflammation evaluation (blood and sputum eosinophils count,il-13,feno)and airway responsiveness tests(methacholine bronchial provocation,nasal histamine provocation).

Eligibility criteria:
inclusion criteria: * clinical diagnosis of asthma; * sensitive to house dust mite; * stable for more than 4 weeks with fev1≥70%pred exclusion criteria: * exacerbation within 3 months; * upper airway infections within 6 weeks; * concomitant of hypertension or heart diseases; * pregnancy

Keywords: asthma allergy bronchial hyperresponsiveness provocation
a study of hospital healthcare use and cost in patients in the hospital with a venous thromboembolism (vte) treated with apixaban or warfarin in the us

Conditions: Venous Thromboembolism (VTE)

Summary: a study involving real-world database analysis to evaluate the hospital healthcare utilization and costs, and all-cause, major bleeding-, clinically relevant bleeding-, any bleeding-, and venous thromboembolism (vte)-related hospital readmissions among hospitalized vte patients treated with apixaban or warfarin, with or without low molecular weight heparin (lmwh)


Eligibility criteria:
inclusion criteria: * have a primary diagnosis of vte identified by icd-9-cm or icd-10 codes from the premier hospital database between 01-aug-2014 and 31-may-2016 * age 18 years or older as of index hospitalization with vte diagnosis * patients will be required to have received apixaban or warfarin with or without lmwh (index drugs) during the index hospitalizations exclusion criteria: * received both apixaban and warfarin during the index hospitalization. this exclusion criterion will allow to cleanly group patients into the apixaban and warfarin usage cohorts. * received any other direct oral anticoagulants (doac) including rivaroxaban, dabigatran, and edoxaban during the index hospitalization * have any primary or secondary diagnosis code for atrial fibrillation/atrial flutter (af/afl), or pregnancy, or records of inferior vena cava filter (ivcf) usage during the index hospitalizations or the baseline periods. * patients transferred from other facilities other protocol-defined inclusion/exclusion criteria could apply
nadroparin anticoagulation for continuous venovenous hemofiltration

Conditions: Kidney; Acute Renal Failure; Multiple Organ Failure

Summary: the low molecular weight heparin nadroparin is used for anticoagulation of the extracorporeal hemofiltration circuit. continuous hemofiltration is a renal replacement modality for intensive care patients with acute renal failure. up to now it is not known whether nadroparin is removed by hemofiltration or not. accumulation would increase the risk of bleeding. aim of the present study is to determine 1. whether nadroparin accumulates in plasma 2. whether nadroparin is removed by filtration and whether removal depends on hemofiltration dose 3. the effects of nadroparin during critical illness on coagulation and anticoagulation

the low molecular weight heparin (lmwh) nadroparin is used for anticoagulation of the extracorporeal hemofiltration circuit. lmwh accumulate in patients with chronic renal failure. continuous venovenous hemofiltration (cvvh) is a renal replacement modality for intensive care patients with acute renal failure. up to now it is not known whether nadroparin is removed by hemofiltration or not. if not, accumulation is expected and the risk of bleeding for the patient increases. because critically ill patients are at increased risk of bleeding, this question is crucial. if nadroparin would be removed by filtration, removal is expected to depend on hemofiltration dose (to be greater with a higher dose) we therefore designed a randomized controlled cross-over trial in the setting of critical illness and acute renal failure comparing the anticoagulant effect of nadroparin (anti-xa) between two doses of cvvh in the patients blood, in the extracorporeal circuit and in the ultrafiltrate. because hemostasis in critically ill patients is not only influenced by anticoagulation but also by the critical illness and the extracorporeal circuit, we also measure other hemostatic markers, especially the endogenous thrombin potential (etp), which seems the most global marker of hemostasis, incorporating procoagulant and anticoagulant effects.

Eligibility criteria:
inclusion criteria: * acute renal failure requiring renal replacement therapy exclusion criteria: * (recent) bleeding or a suspicion of bleeding necessitating transfusion, * need of therapeutic anticoagulation or * (suspected) heparin-induced thrombocytopenia

Keywords: anticoagulation hemofiltration acute kidney injury heparin hemostasis nadroparin anti-xa endogenous thrombin potential
seminal level of clusterin before testicular sperm extraction

Conditions: Azoospermia, Nonobstructive

Summary: measurement of clusterin level in the semen of infertile males undergoing testicular sperm extraction.

clusterin, known as apolipoprotein j, sulphated glycoprotein-2 or testosterone - repressed prostate message-2. it plays important roles in several pathophysiological processes, including tissue remodelling, lipid transport, reproduction, complement regulation and apoptotic cell death . as clusterin expression is markedly upregulated in various normal and malignant tissues undergoing apoptosis, it has been regarded as a marker for cell death. there is a conflicting findings concerning the relationship between elevated clusterin expression and enhanced induction of apoptosis; that is, clusterin has appeared to have a powerful anti-apoptotic function through a chaperone-like activity. in addition to the anti-apoptotic activity, seminal clusterin was reported to promote a tolerogenic response to male antigens, thereby contributing to female tolerance to seminal antigens. in the testis, clusterin is secreted by sertoli cells into the fluid of the seminiferous epithelium and deposited onto the membranes of elongating spermatids and mature spermatozoa. to date, however, there has been little information with respect to the functional roles of clusterin in the male reproductive tract under physiological conditions. in particular, it remains controversial as to whether or not clusterin helps assist the normal spermatogenesis. nonobstructive azoospermia (noa) males are characterised by impaired spermatogenesis. although noa patients have impaired global spermatogenic function, focal areas of spermatogenesis may still exist in their testes. focal spermatogenesis could possibly be obtained by testicular sperm extraction (tese) technique . a number of factors have been suggested to be of predictive value for patients with a good chance to retrieve sperm cell such as testicular volume, serum fsh levels , serum total testosterone and serum inhibin b levels.

Eligibility criteria:
inclusion criteria: * infertile males , azoospermia undergoing tese as a preliminary step for icsi . * age: 20-50 year exclusion criteria: * males \ 50years * cryptorchidism . * testicular agenesis and testicular atrophy .
antibody response to influenza vaccine in patients with sarcoidosis

Conditions: Pulmonary Sarcoidosis

Summary: the purpose of this study is to determine the efficacy of influenza vaccine (antibody response) in patients with sarcoidosis.

sarcoidosis is a multisystem disease with unclear etiology characterized by the presence of noncaseating granuloma\[1\]. t helper cells response is exaggerated at the site of disease and cellular immunity depressed in peripheral blood\[2\]. cutaneous anergy, lymphopenia and inversion of cd4/cd8 ratio in peripheral blood suggest t helper cells involvement\[3\]. the action of humeral immune system in sarcoidosis is a matter of controversy. standard hepatitis b virus vaccination did not provoke protective antibody titer in patients with sarcoidosis\[3\]. although antibody response against influenza vaccine in patients with sarcoidosis is not well described, this vaccine is highly recommended in patients with chronic pulmonary diseases such as asthma, copd and fibrosis \[4, 5, 6\]. in this study we aim to evaluate the humeral response to the influenza vaccine in sarcoidosis patients and assess vaccine safety.

Eligibility criteria:
inclusion criteria: sarcoidosis patients: * patients with relevant clinical, radiologic and histologic features of sarcoidosis (all stages). * signed informed consent. exclusion criteria: * organ failure (kidney, heart, liver). * collagen vascular diseases. * diabetes. * contraindications of vaccine (egg allergy). * patients who receive high dose (\> 60 mg/day) steroid therapy. * any acute disease. * conditions accompanied by immunosuppression (like organ transplantation, hiv). * any psychological disease that interferes with regular follow-up. * inoculation with influenza vaccine within the past 5 years.

Keywords: influenza vaccine sarcoidosis antibody
comparison of three methods of taking temperatures in the newborn intensive care unit

Conditions: Thermometry

Summary: preterm infants will have their body temperature measured by three different devices in order to evaluate whether the newest device, a temporal artery scanning thermometer, is accurate for patients in the preterm period.


Eligibility criteria:
inclusion criteria: * preterm infants corrected to 30-35 weeks gestation * current incubator set on air control between 28-30 degrees centigrade exclusion criteria: * infants \ 35 weeks gestation * infants requiring \> 30 degrees centigrade in incubator on air control * infants currently not in an incubator

Keywords: temporal artery thermometer temperature preterm infants
a phase 3 study to investigate the safety and efficacy of pa21, a phosphate binder, in dialysis patients

Conditions: Chronic Kidney Disease Requiring Chronic Dialysis

Summary: this is a phase 3, randomised, active controlled, multicentre study to investigate the safety and efficacy of pa21, a phosphate binder, for control of hyperphosphataemia in dialysis patients. the primary objective is to establish the efficacy of pa21 for lowering phosphate levels in these patients.


Eligibility criteria:
inclusion criteria: * dialysis patients with hyperphosphataemia (≥ 1.94 mmol/l; ≥ 6.0 mg/dl) * stable dose of phosphate binder * written informed consent exclusion criteria: * hyper/hypo calcemia; hyper intact parathyroid hormone (ipth) * other significant medical conditions * pregnancy

Keywords: pa21 phosphate binder
antibiotic treatment duration for non-surgically-treated diabetic foot osteomyelitis

Conditions: Diabetes Mellitus

Summary: the purpose of the study is to compare the efficacy and tolerance of 6- versus 12-week antibiotic therapy in patients with diabetic foot osteomyelitis treated medically.

the aim of this randomized multicenter clinical study is to compare the efficacy and tolerance of 6 versus 12-week antibiotic treatment in patients with diabetic foot osteomyelitis treated medically as no equivalent data are currenty available in the literature.

Eligibility criteria:
inclusion criteria: * diabetic patients treated non-surgically (i.e. without amputation or resection of the infected bone) for an osteomyelitis of the foot complicating a neuropathic foot without ischemia of the foot defined as the absence of any pedal pulse. patients aged of 18 years or more were included if they had type 2 diabetes and osteomyelitis of the foot (i.e.below the ankle). exclusion criteria: * patients with gangrene or who require bone resection or amputation when osteomyelitis of the foot was diagnosed

Keywords: diabetic foot osteomyelitis, antibiotic treatment duration
barotrauma in hyperbaric oxygen therapy

Conditions: Barotrauma

Summary: the purpose of this research is to study whether the use of pseudoephedrine can help prevent middle ear trauma during hbot. pseudoephedrine is an approved drug that is used for temporary relief of nasal or sinus pain and pressure.

subjects will be asked to take a pill (pseudoephedrine or placebo) between 45 and 120 minutes before hyperbaric oxygen therapy. subjects' ears will be examined before and after therapy and be asked to assess ear pain. there will be no further tests or procedures after completion of therapy session and ear examinations.

Eligibility criteria:
inclusion criteria: * new patient requiring hbot (either inpatient or outpatient) * age greater than or equal to 18 years and less than 80 years * fluent in english * full decision capacity * able and medically cleared to swallow a pill exclusion criteria: * enrollment would delay hyperbaric therapy more than 30 minutes in patients with emergent indications (example: central retinal arterial occlusion, carbon monoxide, air gas embolism) * contraindication to pseudoephedrine (monoamine oxidase inhibitors (maoi) use, pregnancy, glaucoma, heart disease, allergy to drug class) * systolic blood pressure \>160 * diastolic blood pressure \> 90 * heart rate \>100 * decongestant/antihistamine/pseudoephedrine/nasal steroid/oxymetazoline use within 12 hours. * prisoner * intubated * unable to swallow oral medications

Keywords: hyperbaric oxygen therapy
does vitamins c and e supplementation of after preterm rupture of membranes prolong the duration of latency? a prospective randomized controlled study

Conditions: Preterm Premature Rupture of Membranes

Summary: preterm premature rupture of membranes (pprom) is a complication affecting 3-4.5% of all pregnancies. pprom is the main known cause of preterm delivery and is associated worldwide with increased rates of neonatal and maternal morbidity and mortality. despite its frequency, very little is known about its pathophysiologic mechanisms. mechanical strength is provided to fetal membranes by an extracellular collagen matrix. types i, ii, iii and iv are the main collagen types in these membranes. studies have shown that total collagen content is reduced in the amnion of women with preterm prom. vitamin c is involved in the metabolism of collagen and has been proposed to play an important role in the maintenance of the integrity of the chorioamniotic membranes. vitamin e may play a synergic role with vitamin c, increasing the antioxidant capacity against reactive oxygen. woods et al hypothesized that an increase in dietary consumption or supplementation of vitamin c and e during pregnancy might reduce the risk of that portion of preterm prom that may be mediated by oxidative injury to fetal membranes. plessinger et al report that pretreatment of human amnion-chorion with vitamins c and e prevents hypochlorous acid-induced membrane damage. borna et al. reported a randomized, double-blind controlled study of vitamin c and e supplementation, in which women with preterm rupture of membranes and singleton gestations at 26 to 34 weeks were randomized to vitamin c and e supplementation or placebo. supplementation with vitamin c and e were associated with longer latency before delivery. however, the sample size in this study was very small. the aim of this study was to evaluate the effect of supplementation with vitamins c and e after preterm premature rupture of membranes. we hypothesised that supplementation vitamins c and e may be effective in decreasing oxidative stress and increasing the latency period.


Eligibility criteria:
inclusion criteria: patients with a single nonanomalous fetus and pprom at ≥ 24.0 and ≤ 34.0 weeks' gestation. exclusion criteria: fetus with anomalies, chorioamnionitis, experienced pprom within 14 days of either amniocentesis or cervical cerclage placement, multiple gestation, obstetrical indication for immediate delivery, delivery within 24 h of admission intrauterine fetal death at the time of presentation. -
safety, tolerability and immunogenicity of ino-4700 for mers-cov in healthy volunteers

Conditions: Middle East Respiratory Syndrome Coronavirus (MERS-CoV)

Summary: the purpose of this phase 2a, randomized, blinded, placebo-controlled, multi-center study is to evaluate the safety, tolerability and immunogenicity of ino-4700 administered by intradermal (id) injection followed by electroporation (ep) using the cellectra™ 2000 device in healthy adult volunteers for middle east respiratory syndrome coronavirus (mers-cov) infection. this study is divided into 2 parts: part 1- dose finding stage and part 2- dose expansion stage.


Eligibility criteria:
key inclusion criteria: * judged to be healthy by the investigator on the basis of medical history, physical examination and vital signs performed at screening; * able and willing to comply with all study procedures; * screening laboratory results within normal limits; * negative tests for hepatitis b surface antigen (hbsag), hepatitis c antibody and human immunodeficiency virus (hiv) antibody; * screening electrocardiogram (ecg) deemed by the investigator as having no clinically significant findings (e.g. wolff-parkinson-white syndrome); * be post-menopausal or be surgically sterile or have a partner who is sterile or use medically effective contraception with a failure rate of \< 1% per year when used consistently and correctly from screening until 3 months following last dose. key exclusion criteria: * pregnant or breastfeeding, or intending to become pregnant or father children within the projected duration of the trial starting with the screening visit until 3 months following last dose; * history of respiratory diseases such as asthma, chronic obstructive pulmonary disease (copd) or chronic bronchitis; * currently participating in or has participated in a study with an investigational product within 30 days preceding day 0; * previous receipt of any vaccine within 30 days preceding day 0 or planning to receive any vaccine during the timeframe restricted per the protocol; * previous receipt of an investigational vaccine product for the prevention of mers; * prior exposure to mers-cov or camels; * participants who participate in mers-201 part 1 cannot participate in mers-201 part 2; * fewer than two acceptable sites available for id injection and ep considering the deltoid and anterolateral quadriceps muscles; * prisoner or participants who are compulsorily detained (involuntary incarceration); * current or anticipated concomitant immunosuppressive therapy (excluding inhaled, topical skin and/or eye drop-containing corticosteroids) prior to dosing. systemic corticosteroids must be discontinued at least 3 months prior to first dose; * reported active drug or alcohol or substance abuse or dependence.

Keywords: healthy coronavirus