Kornimate/medical-research-clean huggingface dataset:
a comparative study of inhaled ciclesonide versus placebo in children (6-11 years) with asthma

Conditions: Asthma

Summary: the purpose of this study is to investigate the efficacy of inhaled ciclesonide at three different dose levels compared with placebo with respect to pulmonary function, asthma symptoms, and use of rescue medication in children aged 6-11 years with asthma. treatment medication will be administered as follows: ciclesonide or placebo will be inhaled once daily in the evening. the study consists of a baseline period (2 to 4 weeks) and a treatment period (12 weeks). the study provides further data on safety and tolerability of ciclesonide.

the drug being tested is called ciclesonide. this study looked at the safety and efficacy of inhaled ciclesonide in children with asthma. the study enrolled 1080 patients. participants were randomly assigned to 1 of 4 treatment groups which were undisclosed to the patient and study doctor during the study:• ciclesonide 40 µg, 80 µg or 160 µg • placebo- this is similar to study drug but has no active ingredient. ciclesonide was inhaled via a metered-dose inhaler (mdi with hfa-134a propellant), with or without spacer, once daily in the evening throughout the study. all participants were asked to document daily am and pm peak expiratory flow (pef), daytime and nighttime asthma symptom scores and number of puffs of rescue medicine in an electronic diary. this multi-centre trial was conducted worldwide. the overall time to participate in this study was 20 weeks. participants made multiple visits to the clinic plus a final visit 30 days after the last dose of study drug for a follow-up assessment.

Eligibility criteria:
main inclusion criteria: * history of asthma for at least 6 months * ability to show optimal use of mdi, including inhalation technique * lung function and reversibility within specified limits main exclusion criteria: * concomitant severe diseases * diseases which are contraindications for the use of inhaled steroids * two or more inpatient hospitalizations for asthma within the last year * respiratory tract infection or asthma exacerbation within the last 30 days prior to entry into the study * use of systemic steroids within the last 30 days prior to inclusion (depot steroids 6 weeks) * beginning of or change in immunotherapy within the last 6 months prior to inclusion * inability to follow the procedures of the study

Keywords: asthma ciclesonide children
hyperpolarized xenon-129 mri: a new multi-dimensional biomarker to determine pulmonary physiologic responses to copd therapeutics

Conditions: Chronic Obstructive Pulmonary Disease

Summary: hyper polarized xenon-129 mri (hxe mri) is a unique imaging test which can detect how air is flowing in and out of lungs and how oxygen can move from inhaled air into the blood. chronic obstructive pulmonary disease (copd) is a disease in which patients develop narrowing of airways, thus, having difficulties breathing air in and out their lungs and also damaging the lung tissues which patients need to move oxygen from the air into blood. in this study, two drugs which are already approved by fda (anoro and arnuity) will be administered to patients who are already known to have copd. while patients are being treated with these two drugs (one drug at a time over a month), lung health by using usual testing methods (ct scan of the lung, pulmonary function test, and blood test) will be assessed in addition to hxe mri. the goal of this study is to prove that the hxe mri is an excellent imaging test to show the state of lung health among copd patients and also to obtain new informations on how lung health changes with drugs that are already approved by us fda. this work is anticipated to help develop hxe mri as a new clinical test which can guide how to treat patients with copd and if new therapies can improve lung health of patients with copd.


Eligibility criteria:
inclusion criteria: * post bronchodilator pft spirometry fev1/fvc \< 70% predicted * history of diagnosis of copd * history of alpha 1 anti-trypsin deficiency exclusion criteria: * previous diagnosis of asthma, interstitial lung disease, pulmonary vascular disease, inability to complete mri or any of the assessment testings.

Keywords: chronic obstructive pulmonary disease copd emphysema mri hyper polarized gas mri
the pcornet blood pressure home monitoring study

Conditions: Hypertension

Summary: the pcornet blood pressure home monitoring (bp home) study is a patient-level randomized controlled trial that will compare the effectiveness of home blood pressure monitoring (hpbm) with versus without a linked smartphone application ("app") for helping patients with uncontrolled hypertension achieve a reduction in systolic blood pressure. the trial will be conducted within the national patient-centered clinical research network (pcornet), which supports a research network that enables distributed querying of ehr data in a common data model. it will also use the eureka research platform, an online research platform hosted by ucsf that supports econsent, online surveys, and data collection from devices such as hbpms. data from these two data sources will be used together to accomplish the study aims. given that hbpm is the guideline-recommended standard of care (without specification of smartphone linkage), the hpbm devices and the app are all commercially available and currently in use, and that clinicians, with input from patients, will maintain full control of how bp is clinically managed, we believe participation in the project poses minimal risk to participants.

we have designed a patient-level randomized controlled trial that will compare the effectiveness of smartphone-linked versus standard hbpm for helping patients with uncontrolled hypertension achieve a reduction in their systolic blood pressure (sbp), and patient satisfaction with the device. our original plan was to recruit 2000 patients who would be randomized in a 1:1 ratio to receive a smartphone-linked or standard hbpm. however, to recruit higher diversity with more african americans and latinx patients, we extended the recruitment period.\* we will use data from the electronic health record (ehr), an online patient portal, and the home bp monitor (in the smartphone-linked arm) to collect outcome data for a period of at least 6 months (for the primary outcome), and up to 18 months (for secondary outcomes, depending on enrollment date). the primary bp control outcome will be reduction in sbp, by clinic measurements, at 6 months. the primary patient satisfaction outcome will be the net promoter score derived from self-reported likelihood of recommending the device to a friend, at 6 months. \*edited after completing recruitment

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * at least one ambulatory visit in one of the participating study sites during the past year * sbp \> 145 mmhg at most recent clinic visit (may be treated with bp meds already or not) * a self-reported commitment to "work on lowering your blood pressure by 10 points or more to reduce your risk of heart attack and stroke" * owns a smartphone (android or ios) * willing to receive text messages from the study * can read/write english well enough to use english-based smartphone apps and fill out online surveys in english exclusion criteria: * has an arm circumference \ 42 cm * owns a functioning hpbm and has used it in the last 3 months
non-invasive current stimulation for restoration of vision

Conditions: Stroke; Electrical Stimulation

Summary: the aim of the study is to evaluate effects of current stimulation of the brain on vision parameters, vision-related quality of life, and physiological parameters to uncover mechanisms of vision restoration. these include eeg-spectra and coherence measures, and visual evoked potentials. the design of stimulation protocols involves an appropriate sham-stimulation condition and sufficient follow-up periods to test whether the effects are stable. this is the first application of non-invasive current stimulation for vision rehabilitation in stroke-related visual field deficits.


Eligibility criteria:
inclusion criteria: * hh due to ischemic or hemorrhagic stroke * age between 18 and 75 years * lesion age at least 6 months * stable visual field defect across baseline measurement (subjects with spontaneous fluctuations and recovery of vision excluded) * presence of residual vision and detectable gradual transition between the intact and the absolutely blind part of the visual field according to evaluation of the clinician * best corrected visual acuity at least 0.4 (20/50 snellen) or better exclusion criteria: * known active malignancy * eye or central nervous system diseases that interfere with the study (including poorly controlled glaucoma) * electric or electronic implants (e.g. heart pacemaker) * metal artifacts in the eyes or head (with the exception of dental prosthesis or shunts) * expected low compliance (e.g. in case of known psychiatric disease, known drug abuse, and dementing syndromes) * epileptic seizure within the last 10 years * use of antiepileptic or sedative drugs
a study to evaluate corrected qt interval and drug-drug interaction of trastuzumab on carboplatin in the presence of docetaxel in patients with her2-positive metastatic or locally advanced inoperable cancer

Conditions: Solid Cancers

Summary: this phase ib, multicenter, single-arm, open-label study is designed to evaluate the effect of trastuzumab on qtcf interval and to characterize the effects of trastuzumab on carboplatin pharmacokinetics in patients with her2-positive metastatic or locally advanced inoperable cancer. the qt interval is a measure of time between the start of the q wave and the end of the t wave in the heart's electrical cycle. the qtcf interval is the qt interval as calculated using fridericia's correction; the qtcb interval is the qt interval as calculated using bazett's correction.


Eligibility criteria:
inclusion criteria: * histologic documentation of a her2-positive solid malignancy in patients with metastatic or locally advanced inoperable disease * left ventricular ejection fraction (lvef) \>/= 50% by multiple-gated acquisition (muga) scan or two-dimensional echocardiography (echo) \</= 42 days prior to cycle 1, day 1 exclusion criteria: * history of trastuzumab treatment \</= 100 days prior to cycle 1, day 1 * pretreatment qtcf interval \> 450 ms as determined by local assessment

Keywords: her2+ metastatic cancer her2+ locally advanced inoperable cancer her2+ solid malignancy
adductor canal block after total knee replacement - a suture-method catheter vs a standard catheter vs a single bolus

Conditions: Pain Management

Summary: in this study we wish to investigate the analgesic effect of the administration of 0.2% ropivacaine for an adductor canal block as repeated boluses (20 ml every 8 hours) through a new suture-method catheter or a standard perineural catheter compared with a single bolus (20 ml), in patients following primary total knee arthroplasty.

the aim of the study is to compare the clinical effects of three different administration forms for an acb: repeated intermittent boluses through a certa catheter (cc) versus repeated boluses through a standard catheter (through the needle) (sc) versus a single bolus (sb). our dual hypothesis is that repeated boluses through a catheter (either certa or standard catheter) reduces opioid consumption (primary outcome), as well as reduces pain scores, enhances ambulation and muscle strength compared with a single bolus, and that the certa catheter is superior to a standard catheter.

Eligibility criteria:
inclusion criteria: * patients scheduled for unilateral total knee arthroplasty in spinal anesthesia * patients who gave their written informed consent to participating in the study after having fully understood the contents of the protocol and restrictions * asa 1-3 * ability to perform a tug test preoperatively exclusion criteria: * patients who cannot cooperate * patients who cannot understand or speak danish. * patients with allergy to the medicines used in the study * patients with a daily intake of strong opioids (morphine, oxycodone, ketobemidone, methadone, fentanyl) during the last 4 weeks * patients suffering from alcohol and/or drug abuse - based on the investigator's assessment * rheumatoid arthritis * bmi \> 40 * neuromuscular pathology in the lower limbs * pregnancy

Keywords: pain total knee arthroplasty regional anesthesia
rural-urban disparities in the nutritional status of younger adolescents in tanzania.

Conditions: Undernutrition; Stunting; Adolescent Development

Summary: africa faces rapid urbanization, has the second highest population growth rate, makes up one-fifth of the world's youth population, and experiences stagnant rates of undernutrition. these challenges point to the need for country-specific data on rural-urban health disparities to inform development policies. this cross-sectional study examined disparities in body mass index-for-age-and-sex (baz) and height-for-age-and-sex z-scores (haz) among 1125 adolescents in tanzania. rural-urban disparities in nutritional status were significant and gendered. findings confirm place of residence as a key determinant of baz, haz, and stunting among adolescents in tanzania. targeted gender-sensitive interventions among adolescents, particularly in rural areas, are needed to limit growth faltering and improve health outcomes.

africa faces rapid urbanization, has the second highest population growth rate, makes up one-fifth of the world's youth population, and experiences stagnant rates of undernutrition. these challenges point to the need for country-specific data on rural-urban health disparities to inform development policies. this cross-sectional study examined disparities in body mass index-for-age-and-sex (baz) and height-for-age-and-sex z-scores (haz) among 1125 adolescents in tanzania. pearson's chi-square tested associations between rural/urban residence and undernutrition (baz \<-2sd), stunting (haz \<-2sd), anthropometric, socioeconomic, and health indicators. multivariate linear regression identified predictors of baz and haz. funding: unicef/ tanzania; united states national institute of mental health (r01 mh66801).

Eligibility criteria:
inclusion criteria: * adolescents between 10 and 14 years of age exclusion criteria: * adolescents living away from the districts and not physically present at the time of the study
intraindividual comparison of emo iols

Conditions: Age Related Cataracts

Summary: the investigational devices are approved intraocular lenses (iols) intended to be implanted after phacoemulsification in individuals suffering from age-related cataract with the need of cataract surgery. cataract surgery with precedent bilateral randomized iol implantation will be performed in subjects who have signed an informed consent form. postoperative examinations will be implemented in accordance with the approved investigational plan.


Eligibility criteria:
inclusion criteria: * bilateral age-related cataract planned for phacoemulsification extraction and posterior iol implantation * age 50 to 100 * visual potential in both eyes of 20/25 or better as determined by investigators estimation * normal findings in medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant * irregular astigmatism (acrysof iq vivity iol, ic-8 apthera iol) exclusion criteria: * preceding intraocular surgery or ocular trauma * relevant other ophthalmic diseases that particularly effects the zonular apparatus (such as severe pseudoexfoliation syndrome, preceding cryocoagulation, trauma) * pupil diameter \< 2.0 mm (photopic) * laser treatment * uncontrolled systemic or ocular disease * pregnancy/nursing * childbearing ability
non-operative treatment of pediatric lateral humeral condyle fractures

Conditions: Fracture Humerus; Physeal Fracture

Summary: the diagnosis of lhcf is complicated by radiographic inability to show the full extent of the injury into the chondral (unossified) epiphysis. mri gives a perfect view of these fractures. the safety and feasibility of non-operative treatment based on mri findings in children with elbow fractures has not been investigated in a danish setting. if safe and feasible, the use of mri could dramatically lower the need for surgery in children with lhcf.

the treatment of lhcf has historically most often been surgical with open reduction and fixation. the diagnosis of lhcf is complicated by radiographic inability to show the full extent of the injury into the unossified chondral epiphysis and therefore physicians often opt for open surgical treatment. mri; however, gives a perfect view of these fractures. this project investigates the safety and feasibility of non-operative treatment of lhcf based on mri performed without sedation or anesthesia and seeks to dramatically lower the need for surgery. objectives are to describe functional outcome, radiological healing, secondary fracture displacement and any complications after two years. the investigators hypothesize that undisplaced and minimally displaced lhcf can be treated non-operatively based on mri findings with good functional outcomes after two years. a cohort study design is used to follow 50 children with lhcf.

Eligibility criteria:
inclusion criteria: * diagnosis of acute lateral humeral condyle fracture * fracture \<5 days old * fracture with \<5 mm of displacement on plain radiographs * parental informed consent obtained exclusion criteria: * contraindication(s) to performing an mri * unable to participate in follow-up * existing bone pathology * previous ipsilateral elbow fracture
two-year follow-up to high-intensity multi-component agility intervention that improves clinical and motor symptoms of parkinson's disease

Conditions: Follow up; Parkinson Disease; Rehabilitation

Summary: individualization of exercise is recommended but rarely performed in patients with parkinson's disease (pd). unusually high intensity and individual sensor motor with visuomotor mobility trainer the clinical symptoms, mobility and posture of pd patients. after 3 weeks of intensive treatment, treated patients and the control group were subjected to a two-year observation. objectives: the effect of the unusually highly intense and strictly individualized sensomotor and visuomotor agility program was determined for the clinical symptoms, mobility and stability of non-demented pd patients with a two-year follow-up. detection and comparison of results of patients undergoing biphasic maintenance with the results of intensively treated patients and the control group. patients were recalled every 3 months after the first intensive examination and one year after a one-year control. the results of the active group were continuously compared with the results of the passive and control groups, thus determining the effectiveness of our treatment and the deterioration of the other groups in life-quality. the treated groups will be divided into two. one parkinson's group takes part in a treadmill treatment that takes place 3 times a week for 2 years. the other group does not undergo a special series of exercises after 3 weeks of intensive therapy. main outcome measures: movement disorder society unified parkinson disease rating scale, motor experiences of daily living, a measure sensitive to changes in a broad spectrum of pd symptoms. in group time, repeated measurements of variance analysis were compared to mds-updrs m-edl, beck depression score, pdq-39, eq5d vas, schwab \& england scale for parkinson's disease. the tug test and 12 static posturographic measurements are compared and compared to the healthy group as a standard. an at-limit and individualized sensorimotor and visuomotor agility exercise program vs. standard care, will improve non-demeted, stage 2-3 pd patient's clinical symptoms, mobility, and postural stability by functionally meaningful margins. as a long-term solution, a follow-up treatment can slow down the progression of clinical symtoms.


Eligibility criteria:
inclusion criteria: * parkinson's disease * hoenh yahr scale of 2-3 * instability problem exclusion criteria: * severe heart problems * severe demeanor * alcoholism * drug problems

Keywords: balance posturograpy quality of life
the clinical study of acute pancreatitis treated by tongfusan

Conditions: Acute Pancreatitis

Summary: the purpose of this study is to determine whether tongfusan is effective in the treatment of acute pancreatitis with gastrointestinal dysfunction.

* patient who is diagnosed with acute pancreatitis(ap) should be included. * patients will be divided into two groups as random number table: control group(a) and experimental group(b). * group a will be given mosapride po,and group b will be given tongfusan except for basic treatments of ap. * same investigator will write the case report form. * investigator will collect the patients' blood in three points: on admission, the third day and the seventh day. * otherwise, we need write down patients' clinical manifestation,traditional chinese medicine differentiation, the result of clinical tests. * when the patient discharge, we will write down the treatment measures, therapeutic effect, length of stay and the costs.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of acute pancreatitis，both mild type and severe type exclusion criteria: * pregnant or suckling * cancer in late time * patient near death

Keywords: acute pancreatitis gastrointestinal dysfunction tongfusan shenque acupoint
exenatide pharmacokinetics and pharmacodynamics in gestational diabetes

Conditions: Gestational Diabetes

Summary: this study is being done to study how exenatide, an fda-approved drug that lowers blood sugar in non-pregnant patients with type ii diabetes, works in pregnant women. to do this, the investigators will study the drug's pharmacokinetics (what the body does to the drug; specifically, how quickly your body breaks down and excretes exenatide) and pharmacodynamics (what the drug does to the body; specifically, how effectively exenatide helps the participants' pancreas secrete insulin and how well it controls blood sugar after a meal). there are only two main drug therapies (insulin injections and glyburide pills) currently used for gestational diabetes and not all women achieve good enough blood sugar control without side effects. therefore, the investigators hope to find out if exenatide might also be helpful in gestational diabetes.


Eligibility criteria:
inclusion criteria: * pregnant women (singleton) * gestational diabetes not requiring medical therapy * between 18 and 50 years of age * able to give written informed consent exclusion criteria: * women in the first trimester of pregnancy * hematocrit less than 30% * current or past treatment with any hypoglycemic agent * women with gastrointestinal disease or symptoms consistent with nausea, vomiting, abdominal pain or reflux requiring medical treatment. * women with high triglyceride levels, history of gallbladder or pancreatic disease. * clinical diagnosis or history of any renal insufficiency (or decreased creatinine clearance)