Kornimate/medical-research-clean huggingface dataset:
the onefreeze study

Conditions: Paroxysmal Atrial Fibrillation

Summary: the one freeze study is a prospective multi-center randomized controlled trial to assess the safety and efficacy of one vs. two cryoablations per pulmonary vein for the treatment of atrial fibrillation.

the one freeze trial is an investigator-initiated trial that has been developed by the principals at the university of california, san francisco (ucsf) and with full participation of the steering committee. one freezel is a prospective multicenter randomized controlled trial with a goal to enroll and randomize a minimum of 90 study participants. participants will be randomized in a 1:1 ratio to either pvi with a single freeze per pulmonary vein (1f group) or to pvi with at least two freezes per pulmonary vein (2f group). the one freeze study's primary aim is to determine if one 3-minute cryoablation per pulmonary vein results in a lower composite adverse event score as compared to the traditional method of using two 3-minute cryoablations per pulmonary vein.

Eligibility criteria:
inclusion criteria: * paroxysmal atrial fibrillation * age ≥ 18 years * life expectancy ≥ 1 year * willing and able to return to and comply with scheduled follow-up visits * willing and able to provide written informed consent exclusion criteria: * history of \> 5 electric cardioversions * history of previous pulmonary vein isolation ablation for atrial fibrillation * history of maze procedure * left ventricular ef ≤ 35% within the past 12 months * mechanical mitral valve * single pv \> 30 mm in diameter, unless deemed appropriate by the site pi * stroke/tia within the past 6 months * creatinine \> 2.0 mg/dl within the past 6 months * pregnancy or desire to get pregnant within the next 12 months * current enrollment in an investigation or study of a cardiovascular device or investigational drug that would interfere with this study * mental impairment or other conditions, which may not allow the participant to understand the nature, significance and scope of the study * any other condition or circumstance that in the judgment of the clinical site investigator that makes the participant unsuitable for the study
risk factors and machine learning model for diuretics related acute kidney injury

Conditions: Diuretic Toxicity; Acute Kidney Injury

Summary: acute kidney injury (aki) is a series of clinical syndromes in which serum creatinine (scr) concentrations increase over a short period of time, or urine output decreases. it has become an increasing global concern.drug-induced acute kidney injury (d-aki) refers to kidney injury caused by drugs or their metabolites within 7 days after the use of one or more drugs. the kidneys are rich in blood flow and have the function of acidifying the urine, making them an easy target for drug toxicity. besides, there are enzymes in the kidney that metabolize some drugs, and if these drugs are metabolized abnormally in the kidney, substances toxic to the kidney may be produced.it was found that about 20% of aki in hospitalized patients was caused by medications.diuretics are one of the well-known nephrotoxic drugs, since they can directly or indirectly cause a significant decrease in renal blood perfusion and glomerular filtration rate through the mechanism of affecting tubulobulb feedback, which leads to kidney ischemia and hypoxia.however, there are few real-world studies on the incidence of aki in hospitalized patients received diuretics. in this study, we aimed to explore the incidence and risk factors analysis of aki in hospitalized patients received diuretics and develop the machine learning model for diuretics related aki based on electronic medical record data. with the individual characteristics of patients, the risk of aki can be evaluated before receiving diuretics, which may provide useful information for clinical decision making to better prevent d-aki.


Eligibility criteria:
inclusion criteria: all inpatients who used diuretics during hospitalization hospital stay ≥ 48h age ≥ 18 years there were two or more blood creatinine tests during hospitalization exclusion criteria: hospital stay \< 48h age \< 18 years gfr \< 30ml/min/1.73m2 within 48 hours after admission aki was diagnosed on admission less than two scr test results during hospitalization the scr values were always lower than 40 μmol/l during hospitalization cases with incomplete medical history information

Keywords: diuretics aute kidney injury pharmacoepidemiology miss diagnosis risk factors logic regression
evaluating the ability of zoledronic acid to reduce the rate of subsequent osteoporotic fractures after a hip fracture

Conditions: Osteoporosis; Hip Fracture

Summary: the purpose of this study is to evaluate whether zoledronic acid given once yearly for two years to men and women after surgical repair of a recent hip fracture will significantly reduce the rate of all re-occurring (new) osteoporotic fractures. all patients will receive vitamin d and calcium.


Eligibility criteria:
inclusion criteria: * male or female ages 50 years or older * must have a recent hip fracture repair in the past 90 days * must be able to walk with or without assistive device (for example, using a walker) prior to the hip fracture exclusion criteria: * current bisphosphonate users such as aredia (pamidronate), didronel (etidronate), fosamax (alendronate), actonel (residronate), skelid (tiludronate) other protocol-defined inclusion/exclusion criteria may apply.

Keywords: hip fracture recurrent fracture fracture bone loss bisphosphonate bone mineral density osteoporosis zoledronic acid geriatrics rehabilitation elderly nursing home orthopedic
iron supplementation of marginally low birth weight infants

Conditions: Anemia; Iron-Deficiency; Child Behavior Disorders; Cognitive Manifestations

Summary: iron is essential for brain development and there is a well established association between iron deficiency in infants and poor neurological development. in sweden, about 5% of newborns have low birth weight (\< 2500 g). due to small iron stores at birth and rapid postnatal growth, they have increased risk of iron deficiency and it is therefore important to prevent iron deficiency in this population. however, excessive iron supplementation can have adverse effects in infants such as growth impairment. in a randomized, controlled trial, we are investigating the effects of 0, 1 or 2 mg/kg/d of iron on brain myelination, cognitive development and growth in low birth weight infants.


Eligibility criteria:
inclusion criteria: * marginally low birth weight (2000-2500 g) * healthy at inclusion(6 weeks of age) * no previous blood transfusion * no previous iron supplementation exclusion criteria: * anemia at inclusion

Keywords: iron supplements infant low birth weight prevention of iron deficiency and its physiological consequences safety
this is a study of bioavailability and food effect for fesoterodine.

Conditions: Overactive Bladder (OAB) With Symptoms of Frequency, Urgency, and Urgency

Summary: this is a study of bioavailability and food effect for fesoterodine.

to estimate the bioavailability of three different 4 mg fesoterodine er beads-incapsule formulations compared to 4 mg fesoterodine marketed er tablets under fasting and fed conditions.

Eligibility criteria:
inclusion criteria: * healthy male and/or female subjects between the ages of 18 and 55 years exclusion criteria: * evidence or history of clinically significant disease

Keywords: bioavailability food effect
evaluation of potential off-label use of dabigatran etexilate in europe

Conditions: Atrial Fibrillation

Summary: this is a descriptive, observational, multi-country european cross-sectional study of new users of dabigatran etexilate that aims to characterise on- and off-label status and other medical characteristics at the time of the first captured prescription of dabigatran etexilate in each database. the study will be conducted using cegedim strategic database (csd, france), danish national databases (denmark) and clinical practice research datalink (cprd, uk).

study design:

Eligibility criteria:
inclusion criteria: 1. have at least 1 year of enrolment in the electronic database. 2. have not been prescribed dabigatran etexilate during the 1-year period prior to the index date.
exosome micrornas as potential biomarkers of metabolic bone disease of prematurity

Conditions: Exosomes; Newborn; Bone Diseases, Metabolic

Summary: metabolic bone disease of prematurity (mbdp) is caused by insufficient content of calcium, phosphorus, and organic protein matrix in preterm infants or bone metabolism disorder, which is one of the complications affecting the quality of life of preterm infants. the early symptoms of mbdp are insidious, and there is no unified and clear diagnostic method. the diagnosis is mostly based on typical clinical manifestations and x-ray findings, but at this time, bone mineral density has decreased significantly, so early detection and diagnosis are difficult. studies have shown that exosomal micrornas have biological characteristics and targeting specificity, and can be used as new molecular diagnostic markers for diseases. several studies have reported the use of plasma or serum micrornas as molecular markers for early prediction of bone diseases. in our previous study, we extracted plasma exosomes from preterm infants for high-throughput sequencing of micrornas, and identified differentially expressed micrornas related to bone metabolism. in this study, exosomes were used as carriers, and digital pcr was used to verify the specificity and sensitivity of plasma exosomal microrna as biomarkers of mbdp in a large sample size. the above biomarkers were compared and verified before and after treatment in children with mbdp. further revealing plasma exosomal microrna as a biological indicator for evaluating the efficacy of mbdp may improve the diagnostic level of mbdp, improve the outcome and prognosis of very low birth weight preterm infants, thereby improving global health and reducing socioeconomic costs.


Eligibility criteria:
inclusion criteria: * the gestational age was 37+0-41+6 weeks and the age was less than 28 days exclusion criteria: * there was no blood transfusion, no operation, no congenital malformation, no inherited metabolic diseases, no history of intravenous nutrition, and no intestinal diseases
comparing effectiveness of duloxetine and desipramine in patients with chronic pain: a pragmatic trial using point of care randomization

Conditions: Chronic Pain

Summary: over 100 million americans suffer from chronic pain resulting in annual cost of roughly $635 billion. limited treatments are available for this widespread disease. the data supporting these treatments lack generalizability to patients with more serious medical and psychological comorbidities who are often excluded from explanatory efficacy trials. our work aims to integrate randomized comparative effectiveness research with patient care. the investigators will randomize the patients and collect data using an open-source learning healthcare system already in use in our department to monitor patients' progress: collaborative health outcomes information registry (choir). collaborative health outcomes information registry uses the national institute of health patient reported outcomes measurement information system item banks for comparative metrics through computer adaptive testing. the investigators will leverage the advantage of this novel system to compare effectiveness of duloxetine and desipramine in decreasing pain in patients with chronic pain. the investigators will also compare adherence of patients to these two commonly used medications over a period of six months. this will evaluate feasibility of integrating randomized comparative effectiveness research with patient care in subspecialty clinics. collaborative health outcomes information registry can then be applied for numerous future trials to advance our knowledge in perioperative and pain medicine.


Eligibility criteria:
inclusion criteria: 1. age of 18 years old or above 2. persistent pain for more than 3 months 3. candidate for treatment by anti-depressant based on treating pain provider exclusion criteria: 1. prior failure of duloxetine and/or desipramine (patients who have failed other tcas or snris can be considered for the trial based on the reason for previous medication failure) 2. contraindication to taking duloxetine or desipramine 3. patient refusal
virtual avatar coaches for behavioral therapy of patients with overactive bladder

Conditions: Overactive Bladder

Summary: this study compares the efficacy of embedding avatars into an online self-management program that teaches oab behavioral therapy on oab-related quality of life, symptoms, self-efficacy, and adherence versus the same program without avatars


Eligibility criteria:
inclusion criteria: * age 55 or older * women living in the community * who could read and speak english * urgency (≥3 episodes/24 hrs.) ± urge urinary incontinence * urinary frequency (≥8 times/24 hrs.) * nocturia (awakening ≥2 times at night) exclusion criteria: * hematuria * abdominal pain * fever * cognitive impairment (mini-cog \< 3) * positive screen for depression (phq2 \> 3) * hearing issues * uncorrected visual difficulties

Keywords: overactive bladder multimedia behavioral therapy
evaluating the effects of surgical and non-surgical treatment options in people with emphysema

Conditions: Pulmonary Disease, Chronic Obstructive; Emphysema

Summary: emphysema is a lung disease that involves damage to the air sacs in the lungs and can lead to breathing difficulties. treatment options for people with emphysema include pulmonary rehabilitation, lung volume reduction surgery, and lung transplantation. this study will observe people with emphysema to assess the effect of these treatment therapies on their quality of life and long-term health.

emphysema is a progressive lung disease that results in shortness of breath and a reduced capacity for physical activity. it is caused by inflammation within the small air sacs and small airways of the lungs, which can lead to the destruction of the air sac walls and eventually to airway collapse. treatment options for emphysema include both non-surgical and surgical interventions. pulmonary rehabilitation, a non-surgical treatment, includes a combination of education, exercise training, nutrition advice, and smoking cessation programs. the goal of pulmonary rehabilitation is to increase exercise tolerance and reduce breathing difficulties. two surgical treatment options include lung volume reduction surgery, in which small amounts of damaged lung tissue are removed, and lung transplantation, in which a person's damaged lung is replaced with a healthy lung from a donor. while these surgical options may offer potential improvements in quality of life, they also impose substantial risks, including infections, pneumonia, or even death. in this study, researchers will follow participants over a long period of time to assess the effects of pulmonary rehabilitation, lung volume reduction surgery, and lung transplantation on health outcomes and quality of life. this study will enroll people with moderate to severe emphysema who have undergone pulmonary rehabilitation, lung volume reduction surgery, or lung transplantation. participants will attend annual study visits and will complete computerized interviews and health-related questionnaires that will assess quality of life factors. study researchers will also review participants' medical records to collect information on lung function and blood test results.

Eligibility criteria:
inclusion criteria: * diagnosed with emphysema * referred for pulmonary rehabilitation, lung volume reduction surgery, or lung transplantation exclusion criteria: * non-obstructive lung disease * chronic obstructive pulmonary disease (copd) that is not predominantly due to emphysema * inability to read english

Keywords: copd lung volume reduction surgery lung transplant quality of life
study to evaluate romosozumab in children and adolescents with osteogenesis imperfecta

Conditions: Osteogenesis Imperfecta

Summary: the primary objective of this study is to evaluate the pharmacokinetics (pk) profile following multiple subcutaneous (sc) doses of romosozumab in children and adolescents with osteogenesis imperfecta (oi).


Eligibility criteria:
inclusion criteria: * ambulatory male or female children 5 to less than 18 years of age upon entry into screening * clinical diagnosis of oi defined as a clinical history consistent with type i-iv oi as determined by presence of expected phenotype and lack of additional features unrelated to type i-iv oi exclusion criteria * history of an electrophoresis pattern inconsistent with type i to type iv oi * history of known mutation in a gene other than collagen type i alpha 1/collagen type i alpha 2 (col1ai/col1a2) causing oi or other metabolic bone disease * history of other bone diseases that affect bone metabolism (eg, osteoporosis pseudoglioma syndrome, idiopathic juvenile osteoporosis, osteopetrosis, hypophosphatasia) * history of kawasaki disease, rheumatic myocarditis, ischemic cardiomyopathy, inherited cardiomyopathies, nephrotic syndrome, familial hypercholesterolemia, stroke, or any thromboembolic disorder * unhealed fracture as defined by orthopedic opinion * symptoms associated with skull abnormalities such as basilar invagination, basilar impression or chiari malformation * prior treatment with anti-sclerostin antibody, fluoride or strontium, parathyroid hormone (pth) within 12 months prior to screening, denosumab within 12 months or zoledronic acid within 6 months prior to first dose * less than 2 evaluable vertebrae by dxa evaluation in the region of interest, l1 - l4, as confirmed by the central imaging laboratory. * clinically significant valvular heart disease based on local echocardiogram (echo) results.
study assessing safety and efficacy of de-101 ophthalmic suspension in dry eye patients

Conditions: Dry Eye

Summary: the purpose of this study is to evaluate if de-101 ophthalmic suspension will safely and effectively improve signs and or symptoms of dry eye disease.


Eligibility criteria:
inclusion criteria: * confirmed diagnosis of dry eye defined by protocol * 18 years or older, and sign written informed consent * negative pregnancy test and utilizing reliable contraceptive throughout study exclusion criteria: * use of any topical ocular medications * any ocular surgery within 90 days of study * laser refractive surgery within one year of study * ocular, lid disease/abnormalities that may interfere with the study * corneal transplants * uncontrolled systemic conditions * females who are pregnant or nursing or planning a pregnancy, or females of childbearing potential who are not using a reliable method of contraception * participated in another drug trial within 30 days prior to study

Keywords: santen dry eye
stylet vs no stylet during ebus tbna

Conditions: Interstitial Lung Disease

Summary: this research study compares two ways to biopsy lymph nodes in the chest using endobronchial ultrasound-guided transbronchial needle aspiration" (ebus-tnba). during a ebus-tbna procedure, the patient is sedated, and a flexible camera and ultrasound probe is inserted through the mouth into the large airways of the chest, allowing us to see (via ultrasound) and biopsy the lymph nodes in the chest. the purpose of this research study is to determine if the ebus-tbna procedure can be made simpler. in today's practice, the biopsy needle has two parts, 1) the needle itself and 2) an inner stylet that runs through the middle of the needle. because many other biopsy needles (such as the needles used in breast biopsy and different types of lung biopsy needles) do not use an inner stylet, the investigators do not think the use of a stylet is necessary. if this step can be safely eliminated without decreasing the effectiveness of the procedure, this could shorten the procedure (saving time). this study is deigned to formally test the hypothesis that a stylet is not necessary in ebus-tbna.


Eligibility criteria:
inclusion criteria: * all patients \>18 years old and capable of informed consent refereed for ebus-tbna at our institution. exclusion criteria: * standard contraindications to ebus (coagulopathy, anti-platlet/anti-coagulant use, clinical instability) * pregnant women
changes in mitochondrial uncoupling protein 2 (ucp2) messenger rna(mrna) in type 2 diabetes (t2dm) patients

Conditions: Diabetes

Summary: many patients with diabetes find difficulties in achieving glycemic control. hemoglobin a1c(hgba1c) is used as a marker for glycemic control. ucp2 is affected by high glucose levels, high free fatty acids and high oxidative stress. the investigators intend to learn about the changes in ucp2 along the process of reaching glycemic control.


Eligibility criteria:
inclusion criteria: * un balanced diabetic patients. exclusion criteria: * no current infection.

Keywords: glycemic control metabolic control oxidative stress diabetes
hd18 for advanced stages in hodgkins lymphoma

Conditions: Hodgkins Lymphoma

Summary: this study is designed to test: 1. in patients with negative positron-emission tomography (pet) after 2 cycles of beacoppesc chemotherapy: whether the number of cycles can be reduced without compromising progression free survival (pfs) (2 further cycles vs. 6 further cycles) 2. for patients with positive pet after 2 cycles: whether intensifying beacoppesc chemotherapy by adding rituximab improves pfs.


Eligibility criteria:
inclusion criteria: * hodgkin lymphoma (histologically proven) * cs (ps) iib with one or both of the risk factors: * bulky mediastinal mass (\> 1/3 of maximum transverse thorax diameter) * extranodal involvement * cs (ps) iii, iv * written informed consent exclusion criteria: * leucocytes \< 3000/µl * platelets \< 100000/µl * hodgkin´s lymphoma as "composite lymphoma" * activity index (who) \< grade 2

Keywords: hodgkin lymphoma pet advances stages rituximab