Kornimate/medical-research-clean huggingface dataset:
high dose vitamin d3 in crohn's disease

Conditions: Crohn's Disease

Summary: this is a randomized, double-blind placebo-controlled trial of high dose vitamin d3 at 10,000 international units (iu) daily compared to low dose at 1000 iu daily in patients with crohn's disease in remission.

in patients with crohn's disease in remission, the investigators hypothesized higher doses of vitamin d would more effectively improve 25-hydroxy(oh)-vitamin d levels and would be tolerated well without side effects of hypercalcemia. the investigators also wanted to explore whether higher doses could reduce the clinical relapse rate of patients with crohn's disease in remission, and if higher doses of vitamin d3 could improve depression and anxiety symptoms. in order to determine if there is benefit from high-dose vitamin d3, the investigators designed a pilot randomized double-blind controlled trial comparing doses of oral vitamin d3 at 10,000 iu daily to 1000 iu daily.

Eligibility criteria:
inclusion criteria: * a prior diagnosis of crohn's disease in clinical remission for at least 28 days with a harvey-bradshaw index less than or equal to 4 * all maintenance therapies for crohn's disease will be required to be at stable dose for at least 3 months before randomization, with no systemic steroid therapy within 4 weeks. * vitamin d supplements will be discontinued at least 6 weeks before randomization. exclusion criteria: * women of child bearing potential who are considering pregnancy during the study period, currently pregnant, or unwilling to use contraception to avoid pregnancy * participants with renal insufficiency (serum creatinine greater than 150 umol/l), sarcoidosis, hyperparathyroidism, malignancy, or any other disorder that may lead to hypercalcemia * patients with short-gut syndrome or a serum albumin less than 32 g/l * concomitant therapy with thiazide diuretics, barbiturates, digitalis, or supplemental products containing vitamin d

Keywords: vitamin d
the impact of early surgery and maintenance of antiplatelet therapy on intraoperative bleeding and major adverse cardiovascular event after percutaneous coronary intervention

Conditions: Acute Coronary Syndrome; Drug-eluting Stent; Aspirin

Summary: recent guidelines of the acc/aha suggest that elective non-cardiac surgery (ncs) should optimally be delayed one year after percutaneous coronary intervention (pci) with drug-eluting stent (des). regarding the antiplatelet agents, dual antiplatelet therapy, or at least aspirin is recommended to be continued considering the relative risk of bleeding and stent thrombosis especially during the first 4 to 6 weeks after des implantation. however, these recommendations are based upon insufficient and conflicting evidences.

recent guidelines of the acc/aha suggest that elective non-cardiac surgery (ncs) should optimally be delayed one year after percutaneous coronary intervention (pci) with drug-eluting stent (des). regarding the antiplatelet agents, dual antiplatelet therapy, or at least aspirin is recommended to be continued considering the relative risk of bleeding and stent thrombosis especially during the first 4 to 6 weeks after des implantation. however, these recommendations are based upon insufficient and conflicting evidences. the aim of our study was (1) to determine independent risk factors for postoperative adverse events and the strength of their association, (2) to assess the incidences of postoperative morbidities including major adverse cardiovascular and cerebral event as a function of time between pci and surgery and (3) to compare bleeding amount and transfusion requirements between different intervals from pci to surgery and durations of antiplatelet agent administration prior to surgery. to achieve this aim, we undertook a retrospective cohort study of the patients who underwent noncardiac surgery after pci with des.

Eligibility criteria:
inclusion criteria: * adult patients who underwent non-cardiac surgery within 5 years after percutaneous coronary intervention with drug-eluting stent at seoul national university hospital between april 2004 and august 2017 exclusion criteria: * patients who underwent percutaneous coronary intervention with balloon angioplasty or bare metal stent
femoropopliteal angiosculpt™ scoring balloon catheter study

Conditions: Peripheral Arterial Occlusive Disease

Summary: this investigation is designed to demonstrate the efficacy and safety of the 4.0-5.0mm angiosculpt scoring balloon catheter (angioscore, inc.) for femoropopliteal use in a controlled clinical investigation. the scoring balloon is a semi-compliant balloon encircled by 3 spiral struts with a nitinol scoring element, which theoretically provides targeted scoring of lesions, by concentrating the dilation force thus minimizing barotrauma, elastic recoil and uncontrolled dissection. this may improve the outcome of the intervention and reduce the number of stents required.


Eligibility criteria:
inclusion criteria: * stenotic (\>50%) or occlusive atherosclerotic disease of the femoropopliteal arteries (primarily superficial femoral arteries - sfa) * length of lesion \>5 cm or 2 times the angiosculpt balloon length (whichever is longer) * reference vessel diameter should be 4.0-6.0 mm * life altering claudication or critical limb ischemia (rutherford 3-5) * no untreated inflow-limiting arterial lesions * at least single vessel run-off until the ankle * the patient must be \> 18 years. * life-expectancy of more than 12 months * the subject or legal guardian has been informed of the nature of the evaluation; agrees to its provisions and has signed informed consent * the patient is capable to follow all evaluation requirements. exclusion criteria: * patient refusing treatment * the reference segment diameter is not suitable for available catheter design * length of lesion is ≥5 cm or requires more than two overlapping angiosculpt balloon inflations (whichever is longer) to cover the entire lesion (however, more than two inflations are permitted within an acceptable lesion length) * the patient has a known allergy to heparin, aspirin or other anticoagulant/antiplatelet therapies or a bleeding diatheses or is unable, or unwilling, to tolerate such therapies * the patient has a history of prior life-threatening contrast media reaction * the patient is currently enrolled in another investigational device or drug trial * the patient is currently breast-feeding, pregnant or intends to become pregnant
safety of ciclesonide nasal spray administered with inhaled fluticasone dipropionate/salmeterol in adults with perennial allergic rhinitis (by9010/m1-409)

Conditions: Perennial Allergic Rhinitis; Allergic Rhinitis; Hay Fever

Summary: the purpose of this study is to evaluate the safety and tolerability of combined ciclesonide nasal spray administered along with a fixed combination of inhaled fluticasone dipropionate/salmeterol.


Eligibility criteria:
main inclusion criteria: * general good health, other than perennial allergic rhinitis * history and diagnosis of perennial allergic rhinitis by skin prick * normal body weight as defined by the study protocol main exclusion criteria: * pregnancy, nursing, or plans to become pregnant or donate gametes (ova or sperm) for in vitro fertilization during the study period or for 30 days following the study period * participation in any investigational drug trial within the 30 days preceding the screening visit * a known hypersensitivity to any corticosteroid or any of the excipients in the formulations * use of any prohibited concomitant medications as defined by the study protocol * previous participation in an intranasal ciclesonide study * non-vaccinated exposure to or active infection with, chickenpox or measles within the 21 days preceding the screening visit

Keywords: allergy perennial allergic rhinitis allergic rhinitis hay fever
age related d-dimer evaluation for the exclusion of a left atrium thrombus in patients with atrial fibrillation (addit-af)

Conditions: Atrial Fibrillation

Summary: patients with atrial fibrillation are at increased risk of thrombus formation in the left heart, especially in the auricula and the atrium. their presence increases the risk of ischemic stroke, especially during cardioversion, performed either by drug or by external electric shock. the gold standard to exclude this thrombus and consider cardioversion is the transesophageal echocardiography. d-dimers, products of the degradation of fibrin, have been studied several times to assess the presence of thrombi in the body, especially in pulmonary embolism. in cardiology and despite several studies on the matter, there is currently no blood d-dimers value allowing to detect the presence of a thrombus with a good predictive value. correlating the d-dimer values with age, as has been done for some years in pulmonary embolism, would give the opportunity to create a simple, inexpensive and widely applicable tool to eliminate the presence of a thrombus in the left heart. if the results are satisfactory, the investigators might consider not using transesophageal echocardiography as this examination is unpleasant for the patient and operator dependant, unlike a standard blood sampling. this study aims to test the following hypothesis: d-dimers values superior or equal to ten times the patient's age is predictive of a thrombus.


Eligibility criteria:
inclusion criteria: * patients with de novo or recent atrial fibrillation requiring cardioversion, either by drug, by an electric shock or an intervention. exclusion criteria: * valvulopathy * infection * neoplasia * inflammatory disease * recent surgery * pregnancy * aorta aneurism * deep vein thrombosis * pulmonary embolism

Keywords: d-dimers atrial fibrillation
trial of rifaximin in the treatment of tropical enteropathy

Conditions: Tropical Enteropathy

Summary: the purpose of this study is to determine whether rifaximin is effective in the treatment of tropical enteropathy in a population of african children at high risk for this disease.


Eligibility criteria:
inclusion criteria: * live in single village exclusion criteria: * acutely malnourished * acutely ill * chronic disease
a quality improvement initiative to increase breast milk use in a chinese nicu: a pilot study

Conditions: Infant, Extremely Premature

Summary: to assess the prevalence of breast milk feeding in a nicu in china, to implement a quality improvement program to increase breast milk feeding, and to evaluate its impact.

the benefits of breast milk are well recognized for providing health benefits in early infancy and extending into adulthood, and breast milk feeding is promoted by numerous professional organizations. however, for various reasons, in neonatal intensive care unit in china, most infants are separated from their parents and are fed infant formula exclusively. to address this problem, the investigators propose to carry out a pilot study to assess the prevalence of breast milk feeding in a nicu of a tertiary teaching hospital in china, and then to introduce an intervention program to increase the prevalence of breast milk feeding and to evaluate the impact of this program. the intervention would include building a nutrition team in the nicu, training of a lactation coordinator and nursing staff by a team from mount sinai hospital, providing parents with education on breast milk feeding, providing access to breast pumps through a lend/lease program and providing a breast pumping room for parents. the investigators will collect data on breast milk feeding, including prevalence and reasons for not breast milk feeding during both the pre-intervention and intervention period. the investigators will also assess the enrolled infants' weight gain from admission to discharge, incidence of nosocomial infection and mortality, and average length of stay in the nicu, to assess the efficacy of the breast milk feeding intervention. this trial has the potential to dramatically change feeding of infants in chinese nicus from exclusive infant formula to breast milk, with potential impacts on nosocomial infection, growth, development and hospital length of stay.

Eligibility criteria:
inclusion criteria: 1. all very low birth weight(birthweight ≤ 1500g)infants admitted to the nicu of children's hospital of fudan university 2. informed consent is given exclusion criteria: 1. presence of breast milk feeding contraindications 2. severe illness with contraindications for feeding
pharmacodynamics and pharmacokinetics of empagliflozin and torasemide in patients with type 2 diabetes

Conditions: Diabetes Mellitus, Type 2

Summary: the primary objective of the study is to investigate the effect of bi 10773, hydrochlorothiazide and torasemide on changes in serum and urine electrolytes. furthermore the pharmacodynamic and pharmacokinetic interactions between bi 10773 and diuretics should be assessed.


Eligibility criteria:
inclusion criteria: 1. male and female patients of type 2 diabetes
a study to test safety and efficacy of baricitinib in participants with diabetic kidney disease

Conditions: Diabetic Kidney Disease

Summary: this is a dose ranging study to evaluate the safety and efficacy of baricitinib in the treatment of participants with mild to moderate diabetic kidney disease.


Eligibility criteria:
inclusion criteria: * participants with type 2 diabetes treated with at least one antihyperglycemic medicine for 12 months * have diabetic kidney disease and receiving one of two specific medicines used to treat high blood pressure or diabetic kidney disease for at least 3 months * estimated glomerular filtration rate (egfr) of 25 to 70 milliliter per minute per 1.73 square meter (ml/min/1.73 m²) (as determined by the chronic kidney disease epidemiology collaboration equation) and a urinary albumin/creatinine ratio (uacr) \>300 milligram per gram (mg/g) and \<5000 mg/g exclusion criteria: * too high blood pressure when you enter the study * some specific medicines used to treat high blood pressure or diabetic kidney disease * frequent high blood glucose levels * renal transplant or past history of dialysis * nonsteroidal anti-inflammatory drugs (nsaids) * had a special x-ray in the past 30 days which involved also receiving an injection of dye into the vein * major surgery within 8 weeks of study entry or will require major surgery during the study * some types of vaccination * shingles or currently have symptoms of a cold sore * serious viral, bacterial, fungal, or parasitic infection, or a urinary infection, tuberculosis (tb) * human immunodeficiency virus (hiv) infection- the virus that causes acquired immunodeficiency syndrome (aids) * have or had some blood disorders, enlarged lymph glands or spleen, or some cancers. * serious circulatory, breathing, liver, stomach or bowel problems, neurological or psychiatric disorders * heart attack or heart failure, or a stroke * other serious disorders or illnesses * electrocardiogram (ecg) heart trace abnormalities * alcohol or illegal drug abuse * donated more than 500 ml of blood in the last 30 days (no blood donations allowed during the study) * pregnant or breastfeeding
l-dep regimen as a salvage therapy for refractory epstein barr virus-induced hemophagocytic lymphohistiocytosis

Conditions: Hemophagocytic Lymphohistiocytosis

Summary: this study aimed to investigate the efficacy and safety of pegaspargase together with liposomal doxorubicin, etoposide and high dose methylprednisolone (l-dep) as a salvage therapy for refractory epstein barr virus-induced hemophagocytic lymphohistiocytosis.


Eligibility criteria:
inclusion criteria: 1. patients were older than 14 years of age 2. diagnosed as ebv-hemophagocytic lymphohistiocytosis (hlh) 3. patients did not achieve at lease partial response after initial treatment including hlh-94 or dep no less than 2 weeks 4. informed consent exclusion criteria: 1. heart function above grade ii (nyha) 2. accumulated dose of doxorubicin above 300mg/m2 or epirubicin above 450mg/m2 3. pregnancy or lactating women 4. allergic to pegaspargase, doxorubicin or etoposide 5. active bleeding of the internal organs 6. uncontrollable infection 7. history of acute and chronic pancreatitis 8. participate in other clinical research at the same time

Keywords: pegaspargase hemophagocytic lymphohistiocytosis epstein barr virus
foot and hip abductor strengthening in patients with knee osteoarthritis.

Conditions: Knee Osteoarthritis

Summary: the study will be randomized controlled trail, subject diagnosed with knee osteoarthritis meeting predetermined inclusion and exclusion criteria will be divided into two groups. pre assessment will be done using pain, rom, function, foot arches and knee alignment as subjective measurement through koos questionnaire, goniometer, 2d frontal plane projection, berkemann foot prints using ink and paper ,30s chair stand test, nine step stair climb,40m fast paced walk test,global rating of change score respectively . one group will be treated with hip abductor strengthening exercise along with conventional exercises and second group will be treated with intrinsic foot muscle strengthening exercise along with conventional exercises. post treatment values recorded after the session.after data collection from defined study setting,data will be entered and analyzed at riphah international university,lahore

knee osteoarthritis (oa) is a leading cause of joint pain1 and disability2 in middle- and older-aged individuals, and is one of the most commonly managed conditions in primary care3. recent incidence rates suggest around 6% of people aged over 45 years develop knee symptoms. knee oa symptoms and radiographic change that worsen over time can lead to costly surgical intervention. compressive forces on the knee caused by knee adduction moment on the medial compartment of the joint are associated with the severity of the disease and intensity of pain. in addition, decreased strength of the quadriceps is one of the contributing factors for the onset of the disease. short foot exercises (sfe) have shown to be effective using the ifm and excluding the efm found that sfe contracted the intrinsic muscles of the foot to increase the inner arch of the foot, thereby shortening the longitudinal arch.pronated foot is deeply related to the medial longitudinal arch (mla) where the presence of a pronated foot consequently leads to a decrease in the mla.

Eligibility criteria:
inclusion criteria: * pain at medial side of the knee. * patient can walk without walking aids. exclusion criteria: * patient with previous hip, knee and ankle surgery. * patient who received intraarticular injection. * patient with neurologic and muscle problem.

Keywords: knee osteoarthritis, koos, strengthening exercises
ketamine infusion for sickle cell pain crisis

Conditions: Anemia; Sickle-Cell, With Crisis; Acute Pain

Summary: the purpose of this study is to prospectively study the efficacy of low dose ketamine infusions in treating patients who are admitted to the hospital with a sickle cell pain crisis. participants will be prospectively randomized in unblinded fashion in the first 12 to 24 hours of an inpatient admission for sickle cell pain crisis to receive pain management without ketamine infusion (group a) versus pain management that includes low-dose ketamine infusion starting at 0.2mg/kg/h (group b). the effect of this intervention on various pain management and healthcare utilization outcome measures will be recorded and analyzed to determine whether or not there is a measurable benefit of using ketamine infusions in this patient population.


Eligibility criteria:
inclusion criteria: * have a pre-existing/known diagnosis of sickle cell disease, prior to the current presentation * admitted to duke university hospital with a clinical diagnosis of sickle cell crisis * are at least 18 years old at time of admission * have been admitted to any hospital for sickle cell pain crisis at least twice in the last year * have documented severe pain at time of admission, requiring intravenous opiates * must be able to speak english exclusion criteria: * are greater than 70 years old at time of admission * carry a diagnosis of cirrhosis, elevated intracranial pressure, elevated intraocular pressure, active coronary artery disease, and psychiatric disorders with history of psychosis * are pregnant or breastfeeding * are concomitantly admitted for another medical or surgical problem in addition to sickle cell pain crisis * have been admitted to any hospital for a sickle cell pain crisis greater than 10 times in the last year * were admitted to any hospital for sickle cell pain crisis within the last 30 days * are able to fully and properly consent for their own medical care, with no restrictions or limitations

Keywords: ketamine intravenous infusions anemia; sickle-cell, with crisis acute pain
three-dimensional ultrasonography thyroid volume measurement.

Conditions: Thyroid; Thyroid Cancer; Thyroid Diseases; Graves Disease; Thyroid Goiter; Thyroid Adenoma

Summary: the purpose of this clinical trial is to investigate the accuracy of applying three-dimensional ultrasound on thyroid gland patients when determining a gland volume. the method will be compared to conventional b-mode ultrasound where three axis measurements (length, width, and depth) are evaluated in the ellipsoid model. the three dimensional (3d) method is utilizing optical tracking connected to the ultrasound image to form cross-sectional imaging. patients enrolled in the study are set for complete thyroidectomies enabling a true volume of the gland by water displacement after excision. the aim is to find if this 3d method is more accurate in volume estimation than the ellipsoid model.


Eligibility criteria:
inclusion criteria: * patients referred to rigshospitalet to undergo a complete thyroidectomy including patients with previous hemithyroidectomy * adults, 18 or older. * ability to give written informed consent exclusion criteria: * thyroid glands that are too enlarged causing visualization/measurement impairment with ultrasonography. * thyroid cancer with preoperative suspected extracapsular spread. * thyroids or lymph nodes that need frozen section examination.

Keywords: ultrasound ultrasonography volumetry thyroid gland three dimensional 3d
therapeutic impacts of theta burst stimulation over bilateral posterior superior temporal sulcus in autism spectrum disorder

Conditions: Autism Spectrum Disorder

Summary: the investigator would like to investigate the impact of intermittent theta burst stimulation over bilateral posterior superior temporal sulcus in autism spectrum disorder


Eligibility criteria:
inclusion criteria: * autism spectrum disorder, confirmed by autism diagnostic observation schedule ii (css≧6) * no change in psychiatric drugs within one month exclusion criteria: * previous or current severe neurological disorder such as epilepsy, visual or hearing impairment * previous or current severe systemic disease such as cardiovascular disease, diabetes or infection * previous or current severe brain injury * implementation of metal materials such as pacemaker or medication pump * previous or current severe psychiatric disorders such as schizophrenia, bipolar disorder or substance abuse * pregnancy * individuals with a significant brain abnormality such as intracranial space occupied lesions * history of brain surgery or nervous system infection, such as meningitis and encephalitis * previous febrile seizures * concurrent use of medications which increased the risk of seizure attack. * participate another clinical trial within one month. * unable to complete mri scan (claustrophobia) * skin trauma on application site * individuals with a large ischemic scar * individuals suffering from multiple sclerosis * individuals suffering from sleep deprivation during rtms procedures * individuals with a heavy consumption of alcohol * individuals with a migraine headache from increased intracranial pressure