Kornimate/medical-research-clean huggingface dataset:
a study in healthy subjects and mild asthmatics to investigate pharmacokinetics of azd5423 when administered in different ways

Conditions: Healthy; Asthma

Summary: a study in healthy subjects and mild asthmatics to investigate pharmacokinetics of azd5423 when administered in different ways.


Eligibility criteria:
inclusion criteria: * male healthy subjects and male asthma patients aged 18 to 45 years (inclusive) * have a body mass index (bmi) between 18 and 30 kg/m2 (inclusive and rounding allowed) and weight between 50 and 100 kg (inclusive) * be able to inhale from the spira nebuliser and i-neb® according to the provided instructions * asthma patients should fulfil the following criteria: pre-bronchodilator forced expiratory volume at 1 second (fev1) ≥70% of predicted normal value * asthma diagnosis according to gina guidelines with a history of episodic wheeze and shortness of breath exclusion criteria: * history of any clinically significant disease or disorder * any clinically relevant abnormal findings * current smokers * asthma patients: worsening of asthma or respiratory infection within 6 weeks before screening * asthma patients: use of inhaled, nasal, oral, rectal or parenteral corticosteroids within 30 days before first administration of investigational product and during the study

Keywords: phase i healthy male volunteers mild asthmatics pharmacokinetics bioavailability and auc level of azd5423 in your blood
sympathetic-vascular dysfunction in obesity and insulin resistance (vitamin c study)

Conditions: Hypertension; Cardiovascular Diseases

Summary: the main purpose of research is to examine and understanding the development of hypertension in obese adults with insulin resistance. findings from our studies will identify unique mechanisms that can be targeted to limit increases in vascular dysfunction and reduce the excessively high prevalence of hypertension and risk for cardiovascular disease (cvd). this study is testing the health of the blood vessels and the activity of the nerves that control the blood vessels in adults with insulin resistance. the extent to which ascorbic acid (vitamin c) improves the function of the blood vessels will be determined. the primary outcome is blood pressure, which is the result of blood vessel health and activity of the nerves, and the reduction in blood pressure that is observed with ascorbic acid.


Eligibility criteria:
inclusion criteria: 1. obese: bmi \>30 m/kg2 2. middle-aged: 35-65 years 3. participants must be willing and able to discontinue taking any vitamin c or e supplements or omega-3 fatty acids beginning 2 weeks prior. 4. able and willing to provide written informed consent exclusion criteria: 1. diabetes mellitus: fasting glucose \< 1267 mg/dl and/or hba1c \< 6.5% 2. currently taking a statin or antihypertension medication 3. hyperlipidemia: fasting triglycerides \< 250 mg/dl 4. hypertension: \<130/80 mmhg 5. history of heart disease (e.g., myocardial infarction, stent) 6. history of vascular disease (e.g., bypass, stroke)
risk factors associated to difficult-to-control asthma

Conditions: ASTHMA

Summary: several studies have demonstrated the efficacy of asthma treatment but despite being correctly diagnosed, conveniently prescribed and adherent to the therapeutics, 5% to 10% of asthmatics do not reach disease control. the aim of this study is to measure asthma control, evaluate inflammatory and functional characteristics, describe comorbidities and aggravating factors and phenotypes derived from the characteristics of a severe asthmatic population followed at an outpatient university service in sao paolo, brazil.

study design: interventional patients selection: seventy-four severe asthma patients, aged between 18 and 65 years old were recruited from the outpatient clinics of the pulmonary division of the university of são paolo hospital. severe asthma were defined according to gina. intervention: after 2 weeks screening period patients were treated with high inhaled corticosteroid dose plus long acting beta 2 agonist during 12 weeks plus oral corticosteroid ( prednisone 40 mg/day) during 2 weeks. procedures ( baseline, after 2 weeks and 12 weeks): asthma control questionnaire (acq), asthma control (act) test, lung function test, quality of life questionnaire (sgrq and sf-36), exhaled nitric oxide (feno), induced sputum (is). after 12 weeks patients underwent the following evaluation: upper digestive endoscopy, esophageal 24hs phmetry, high resolution chest tomography, nasoscope exam,bronchofibroscopy with endobronchial biopsy.

Eligibility criteria:
inclusion criteria: * age between 18 and 65 years * diagnosis of moderate to severe asthma (gina) for at least one year * presence of airway obstruction reversibility (documented within the last 5 years before the start-up of study) * smoking, non-smoking or ex-smoking patients of \<30 pack-years. * need of inhaled corticosteroid (ic),\> or equal 1000mcg of beclomethasone dipropionate (dpb) or similar in the last year plus beta 2 long duration agonist in the last year. * at least one exacerbation with the need of oral corticosteroid in the last year. exclusion criteria: * pregnant women; * co-morbidities that may interfere with the management of the study; * patients who cannot understand the procedures of the study or who are not able to provide their free and clarified consent; * patients with other pulmonary diseases which may interfere with the evaluation of the study.

Keywords: severe asthma risk factors characterization clinical control inflammatory markers severe control
effect of a single dose of cranberry beverage on inflammation and oxidative stress

Conditions: Inflammation

Summary: the purpose of this study is to determine the effects of a single dose of cranberry beverage in healthy adults on the kinetic uptake of polyphenol compounds and polyphenol metabolites, and antioxidative and anti-inflammatory activity.

participants will be randomized based on age, sex and bmi, and will consume a low-polyphenol diet 2 days prior to the intervention. on the day of the study, baseline blood and urine samples will be collected after an overnight fast. participants will consume the assigned beverage within 15 minutes and blood collected at 2, 4, 8, and 24 h (10 ml/blood draw; total blood volume per period = 50 ml). urine will be collected for polyphenol analysis during the following periods: 0-3, 3-6, 6-9, 9-12, 12-24 hours. after a one-week washout period, participants will receive their second and then the third beverage in a cross-over design; blood and urine sampling will be repeated at each of the 3 intervention periods.

Eligibility criteria:
inclusion criteria: * men \& women; aged 18-35 years * bmi: 19-25 kg/m2 exclusion criteria: * any significant chronic disease, hypertension, ulcers, dyspepsia, lactose intolerance, allergy, psychotic illness * had major gastrointestinal surgery or on prescription or surgical treatment * any condition that may interfere with the digestion, absorption, metabolism or excretion of nutrients * regularly smoked in the previous 6 months * on medication or ingested a prescribed drug at any time within the 14 days preceding study enrolment (excluding hormonal contraceptives and hormone replacement therapy) or over-the-counter preparation within 7 days preceding enrolment * risk factors for aids or known hiv positive status * pregnant or lactating * high intake of chocolate or similar high polyphenol foods * regular intake of vitamin and polyphenol supplements * drug and alcohol misuse * currently participating or had participated in another clinical study during the previous 3 weeks * donated blood in the previous 3 weeks * exercise more than 3 times/week for longer than 45 min each time

Keywords: inflammation oxidative stress vaccinium macrocarpon
evaluation of different medicaments in the management of necrotic primary molars by lesion sterilization and tissue repair

Conditions: Pain, Postoperative; Root Resorption; Persistent Infection; Necrotic Pulp

Summary: management of non-vital primary molars is challenging due to the natural anatomy of primary teeth, patients' young age, and their behavior toward dental treatment. a simple and effective technique such as lesion sterilization and tissue repair offers a solution to cases with poor prognosis; however, the medicaments used in this technique have some limitations. this study will evaluate three different medicaments regarding the clinical success, radiographic success, and antibacterial activity.

this randomized controlled trial will include 108 non-vital mandibular primary molars in children aged 4-8. patients will be randomly allocated into three groups according to the studied medicaments as one positive control group and two experimental groups. the groups are as follows: group i (conventional double antibiotic paste) positive control group group ii (double antibiotic paste-loaded chitosan-coated silver nanoparticles) experimental group group iii (chitosan-coated silver nanoparticles) experimental group the antibacterial activity of studied medicaments will be tested against enterococcus faecalis bacteria in planktonic and biofilm forms. teeth will be evaluated clinically and radiographically to obtain baseline data. after local anesthesia administration and isolation of teeth, an access cavity will be performed, then the medicament will be placed over the floor of the pulp chamber according to the corresponding group. afterwards, teeth will be filled with resin-modified zinc oxide and eugenol followed by stainless steel crowns. blinded clinical evaluation will be done at baseline, 1, 6, and 12 months and blinded radiographic evaluation will be done at baseline, 6, and 12 months.

Eligibility criteria:
inclusion criteria: * healthy cooperative children of both sexes in the age range of 4-8 years old. * children with consenting parents who accept to participate in the study and sign the consent forms. * children with mandibular primary molars with clinical and radiographic signs of pulpal necrosis. exclusion criteria: * children with hypersensitivity to any of the used medicaments. * non-restorable teeth without sufficient coronal structure for placement of rubber dam isolation and restoration with stainless steel crowns * non-restorable teeth with perforated pulpal floor
visual acoustic biofeedback for rse via telepractice

Conditions: Speech Sound Disorder

Summary: this research will meet a public health need by evaluating the efficacy of speech intervention supplemented with real-time visual-acoustic biofeedback when delivered using remote technologies.

in a crossover design, participants will be randomly assigned to receive 10 weeks/20 sessions of visual-acoustic biofeedback treatment via telepractice followed by a 10-week period of no treatment, or the same two conditions in the reverse order. production accuracy will be assessed with standard probes (20 syllables, 30 words, and 10 sentences containing /r/ in various phonetic contexts) administered prior to the beginning of treatment (baseline), after the first 10-week phase, and again at the end of the study.

Eligibility criteria:
inclusion criteria: * must be between 9;0 and 15;11 years of age at the time of enrollment. * must speak english as the dominant language (i.e., must have begun learning english by age 2, per parent report). * must speak a rhotic dialect of english. * must pass a pure-tone hearing screening at 20db hearing level. * must pass a brief examination of oral structure and function. * must exhibit less than 30% accuracy, based on consensus across 2 trained listeners, on a probe list eliciting rhotics in various phonetic contexts at the word level. * must exhibit no more than 3 sounds other than /r/ in error on the goldman-fristoe test of articulation-3 (gfta-3). exclusion criteria: * must not receive a t score more than 1.3 sd below the mean on the wechsler abbreviated scale of intelligence-2 (wasi-2) matrix reasoning * must not receive a scaled score of 7 or higher on the recalling sentences and formulated sentences subtests of the clinical evaluation of language fundamentals-5 (celf-5). * must not have an existing diagnosis of developmental disability or major neurobehavioral syndrome such as cerebral palsy, down syndrome, or autism spectrum disorder

Keywords: speech articulation auditory perception
a study to assess the efficacy and safety of the triptorelin 6-month formulation in paediatric participants with central precocious puberty.

Conditions: Central Precocious Puberty

Summary: the purpose of the protocol is to assess the efficacy of the triptorelin 6 month pr (prolonged release) formulation in suppressing lh (luteinising hormone) levels to prepubertal levels (defined as a peak lh ≤5 iu/l) after i.v. gnrh (gonadotropin-releasing hormone) stimulation at month 6 (day 169) in chinese children with cpp (central precocious puberty).


Eligibility criteria:
inclusion criteria: * participant is less than 9 years old for girls and less than 10 years old for boys at initiation of triptorelin treatment or at the time of signing the informed consent. * participant must present evidence of cpp documented by: * onset of development of secondary sex characteristics (breast development in girls or testicular enlargement in boys according to the tanner method: stage ii) before the age of 8 years in girls and 9 years in boys. * pubertal response of lh to gnrh stimulation test (stimulated peak lh ≥6 iu/l) in both sexes. * difference between bone age (ba) and ca \>1 year. * girls with tanner staging ≥2 for breast development and who have enlarged uterine length and/or ovarian volume and at last 2 follicles with diameter \>4 mm in the ovary observed by pelvic type b ultrasound at the screening visit; boys who have testicular volume ≥4 ml observed by testicular orchidometer at the screening visit. * girls who have already had menophania/menarche must have a negative highly sensitive (urine) pregnancy test as required by local regulations within 24 hours before the first dose of study intervention and should not be at risk of pregnancy throughout the study period. exclusion criteria: * gonadotropin-independent (peripheral) precocious puberty: extrapituitary secretion of gonadotropins or gonadotropin-independent gonadal or adrenal sex steroid secretion. * non-progressing isolated premature thelarche. * presence of an unstable intracranial tumour or an intracranial tumour requiring neurosurgery or cerebral irradiation. participants with hamartomas not requiring surgery are eligible. * prior or current therapy with a gnrha (gonadotropin-releasing hormone agonist) , medroxyprogesterone acetate, growth hormone or insulin-like growth factor 1 (igf 1).use of anticoagulants (heparin and coumarin derivatives) within the 2 weeks prior to the screening visit.
the use of endoflip as a clinical tool for the prediction of postoperative gerd after sleeve gastrectomy

Conditions: Gastroesophageal Reflux; Sleeve Gastrectomy; Bariatric Surgery Complication

Summary: this study aims to determine if preoperative endoflip measurement can effectively predict postoperative gerd-related quality of life and lower esophageal acid exposure.

enrolled patients will be subjected to a pre-operative gastroscopy, 48-hour bravo ph study and endoflip. in addition, each patient will complete a gerd-related quality of life questionnaire (gerd-hrql scale). one year after surgery, patients will undergo a follow up a gastroscopy, ph study, endoflip and the same quality of life questionnaire to predict the incidence of postoperative gerd and determine the effect of sleeve gastrectomy.

Eligibility criteria:
inclusion criteria: * age between 18 and 65 years old exclusion criteria: * hiatal hernia \> 2 cm at preoperative gastroscopy * erosive esophagitis at preoperative gastroscopy * barrett's metaplasia/dysplasia at preoperative gastroscopy * revision surgery before the end of the study * pregnancy during the study period * actively bleeding esophageal varices
high definition transcranial direct current stimulation of right inferior frontal gyrus to improve social impairments in children with autism

Conditions: Autism Spectrum Disorder (ASD)

Summary: the goal of this clinical trial is to learn if high definition transcranial direct current stimulation (hd-tdcs) of right inferior frontal gyrus works to improve social impairments in children with autism spectrum disorder (asd). it will also learn about the underlying brain mechanism. the main questions it aims to answer are: * does hd-tdcs of right inferior frontal gyrus improve social impairments in children with asd? * what are the underlying brain mechanisms by which the hd-tdcs of right inferior frontal gyrus improves social impairments in children with asd? researchers will compare participants received active hd-tdcs to controls received sham hd-tdcs (performed to mimic the sensation induced by real hd-tdcs before and after the stimulation) to see if hd-tdcs of right inferior frontal gyrus improves social impairments in children with asd. participants will: * receive a dose of 2 ma hd-tdcs of right inferior frontal gyrus lasting for 10 days. * receive social functioning assessment, functional near-infrared spectroscopy and electroencephalography measurement before and after stimulation * visit the clinic once every 2 weeks for checkups and tests, a total of 2 times.


Eligibility criteria:
inclusion criteria: * had to be 3-18 years old; be diagnosed with asd (according to the diagnostic and statistical manual of mental disorders (dsm-5) and autism diagnostic interview - revised (adi-r). exclusion criteria: * with other comorbid neuropsychiatric conditions (i.e., schizophrenia spectrum disorders and mood disorders) or neurological disorders (i.e., head trauma and epilepsy).

Keywords: autism tdcs social fnirs rct
promoting resilience among adolescents and young adults with sickle cell disease

Conditions: Sickle Cell Disease

Summary: adolescents and young adults with sickle cell disease (scd) face challenges managing their illness and maintaining their well-being. this study proposes to test the feasibility and acceptability of a resilience-promoting intervention through a collaborative care model. the primary goal is to determine with the resilience intervention (prism) is feasible and acceptable for adolescents and young adults with scd. exploratory outcomes include whether this intervention improves depression, anxiety, and pain interference.

adolescents and young adults (ayas) with blood disorders are at risk for poor physical, psychological, and social outcomes. sickle cell disease (scd) is a life-limiting condition, defined as a group of inherited red blood cell disorders disproportionally affecting non-hispanic black, african american, and hispanic/latino groups. ayas with scd experience racial bias, disease-related stigma, and under-treated symptoms, all of which translate to additional challenges managing their illness and maintaining their well-being. this study proposes to address the gaps of mental health support for youth with scd through delivery of a resilience-promoting intervention (prism) using a collaborative care model (cocm). the primary objective of this study is to test the feasibility and acceptability of a collaborative care model to sustainably deliver the prism intervention for ayas with scd. leveraging successful strategies implemented for patients with cancer, we will pilot-test this approach with n=25 ayas in the dana-farber cancer institute/boston children's hospital (dfci/bch) scd clinic. the primary outcome of interest is feasibility, defined as \>50% enrollment. secondary outcomes include patient reported outcomes of feasibility, acceptability, and satisfaction. exploratory outcomes include assessment of depression, anxiety, and pain interference. we hypothesize this will be feasible and acceptable in this patient population.

Eligibility criteria:
inclusion criteria: * aged ≥ 12 and ≤ 25 years of age at baseline * diagnosed with sickle cell disease (hbss, hbsc, hbs-beta thalassemia, and other related hemoglobinopathies) * receiving medical care at the dfci/bch blood disorders center. * scored \> 9 on patient health questionnaire 9-item (phq-9) or generalized anxiety disorder (gad) * able to speak english or spanish language (for prism sessions) * able to read english or spanish language (for completion of surveys) * cognitively able to participate in prism sessions and complete written questionnaires and surveys, as judged by the site investigator * willing and able to adhere to the study visit schedule and other protocol requirements exclusion criteria: \* does not meet above criteria

Keywords: adolescents young adults resilience sickle cell disease collaborative care
anecortave acetate injection to treat steroid-responsive intraocular pressure increase in cornea transplant patients

Conditions: Transplant; Intraocular Pressure

Summary: this study will investigate the use of anecortave acetate injection to reduce intraocular pressure (iop) in corneal transplant recipients who are experiencing steroid-associated pressure control problems. alternative methods of iop control have been shown to entail serious risks. for example, reduction of topical steroids increases the risk of graft rejection, and use of glaucoma medications or glaucoma surgery increases the risk of graft failure. this study is designed to have sufficient power to detect whether a single injection can induce a clinically significant iop reduction.


Eligibility criteria:
inclusion criteria: * at least 18 years of age * corneal transplant recipient with intraocular pressure (iop) greater than 24 mmhg and with relative increase in iop of at least 10 mmhg over the pre-graft baseline exclusion criteria: * not pregnant or lactating * intraocular surgery in the study eye within 30 days before enrolling in the study * use of any investigational drug or treatment within 30 days before receipt of study medication * clinical evidence of scleral thinning

Keywords: cornea transplant intraocular pressure steroid response
covid-19 priority (pregnancy coronavirus outcomes registry)

Conditions: Pregnancy; Coronavirus; COVID-19

Summary: priority (pregnancy coronavirus outcomes registry) is a prospective cohort study of pregnant and recently pregnant women who are: either patients under investigation for covid-19 or a confirmed case of covid-19. data from priority will be used to evaluate the impact of covid-19 on the clinical course and pregnancy outcomes of pregnant women and women within 6 weeks of pregnancy.

the investigators will recruit women age 13 or older under investigation for covid-19 or with confirmed covid-19 at any clinical state across the united states. eligible participants will be identified through voluntary physician referrals. when an eligible patient is referred to the priority coordinating center at ucsf, a ucsf study coordinator will follow-up by phone with the patient and consent verbally. the participant will be asked to complete an approval to release medical information. the investigators will use patient questionnaires to assess symptoms, maternal clinical course, pregnancy outcomes, and neonatal outcomes from initial investigation of covid-19 to 12 months. the investigators will also obtain all medical records for the participant to data abstract key clinical and pregnancy outcomes.

Eligibility criteria:
inclusion criteria: 1. pregnant women or women who have been pregnant within the last 6 weeks 2. able to give informed consent 3. diagnosed with covid-19; or being evaluated for covid-19 ("patient under investigation") since january 1, 2020 exclusion criteria: 1. \<13 years of age.