Kornimate/medical-research-clean huggingface dataset:
a study of oral paricalcitol to treat proteinuric renal disease

Conditions: Proteinuric Renal Disease

Summary: diabetic nephropathy and other proteinuric renal diseases are the major cause of kidney disease in the united states. the degree of proteinuria is associated with risk for renal disease progression and cardiovascular outcomes. deficiency of 1-25 vitamin d develops early in ckd, and is undertreated. vitamin d may have important effects on factors that drive proteinuria and renal disease progression in patients with proteinuric renal diseases. therefore, paricalcitol treatment may reduce proteinuria and slow renal deterioration.

objectives: 1. to determine the effect of oral paricalcitol on protein excretion in patients with proteinuric renal diseases 2. to determine the effect of oral paricalcitol on renal disease progression in patients with proteinuric renal diseases hypothesis: oral paricalcitol will reduce protein excretion in proteinuric kidney disease study design: prospective, randomized, placebo controlled, double blind, trial of paricalcitol compared to placebo. sample size: 60 patients, 30 in each group summary of patient eligibility criteria: subjects with proteinuric renal disease (\>400 mg/24 hours) randomization and dosage: patients will be randomized to treatment with oral paricalcitol (initial dose 1 mcg orally per day) compared to placebo duration : 6 months

Eligibility criteria:
inclusion criteria: 1. stable chronic kidney disease 2. urine protein : creatinine ratio \> 0.4 3. chronic kidney disease stage 2-4 with egfr 15-90 ml/min 4. pth (intact) \>20 pg/ml and \<250 pg/ml 5. age 18-85 6. if on acei/arb, then dose optimized (bp, k) exclusion criteria: 1. failure to provide informed consent 2. glomerunephritis requiring active treatment with immunosuppresive therapy 3. serum phosphorus \> 5.2 4. serum calcium (adjusted for albumin)\> 10.0 5. active malignancy 6. likelihood of requiring renal replacement therapy within 1 year 7. uncontrolled hypertension
25-hydroxyvitamin d and fatigue: the vitality study

Conditions: Irritable Bowel Syndrome; Inflammatory Bowel Disease; Diabetes; Rheumatoid Arthritis

Summary: the burden of chronic disease is continuing to rise. even though patients may be in remission or have quiescent disease, several studies have confirmed that symptoms, such as e.g., fatigue, is troublesome. the primary aim of this study is to investigate whether or not there might be an association between levels of vitamin d and the subjective experience of fatigue in conditions, such as inflammatory bowel disease, diabetes mellitus, rheumatoid arthritis and irritable bowel syndrome. secondary aims is to study both the co-occurence and influence of pain, depression and anxiety.

the burden of chronic disease is continuing to rise. even though patients may be in remission or have quiescent disease, several studies have confirmed that symptoms, such as e.g., fatigue, is troublesome.previous studies have confirmed that vitamin d deficiency is associated with both crohn's disease and rheumatoid arthritis. since vitamin d is associated with both onset of chronic disease and energy, we aim in this study to assess its impact on fatigue in various chronic diseases. the primary aim of this study is to investigate whether or not there might be an association between levels of vitamin d and the subjective experience of fatigue in conditions, such as inflammatory bowel disease, diabetes mellitus, rheumatoid arthritis and irritable bowel syndrome. secondary aims is to study both the co-occurence and influence of pain, depression and anxiety.

Eligibility criteria:
inclusion criteria: * informed consent, * over 18 years of age exclusion criteria: * dementia, * cognitive disorders, * not able to comply with the study procedures, * on active vitamin d treatment
reduction of adverse pregnancy outcomes with a smartphone application in ghana

Conditions: Postpartum Hemorrhage; Delivery, Obstetric; Stillbirth; Infant Mortality; Midwifery

Summary: the purpose of this study is to determine whether use of the safe delivery smartphone application by midwives can reduce excess blood loss from bleeding, and infant death during childbirth in ghanaian women. moreover, it will be investigated whether the safe delivery application can increase midwives' knowledge and skills in managing childbirth. fifteen hospitals in greater accra, ghana, will be cluster randomized to either use the safe delivery application (intervention), or to no intervention (control). in the intervention hospitals, midwives will be educated in the use of safe delivery. pregnant women will be enrolled at delivery and followed until 7 days postpartum. data collection will begin july 2014 and is expected to be finished by october 2014.


Eligibility criteria:
inclusion criteria for hospitals: * located in the region of greater accra. * the hospital should have at least 10 midwives employed. * the patient flow for each midwife should be at least 10 deliveries per month. * the annual average number of deliveries should be at least 1,200. inclusion criteria for midwives: * should have no leave or vacation from june 17th to september 17th 2014. * should have a full time employment at the delivery ward (conducting deliveries 100% of the work time). * should be willing and available to participate in an information meeting at the hospital where the balloting among eligible midwives will take place. * should give an informed consent to participate in the study. * should be willing and available to participate in a workshop july 14th 2014 (this is the day of randomization, and intervention midwives will receive smartphone training). * should be willing and available to participate in a workshop september 17th 2014 (to complete an end of study questionnaire, the key feature questionnaire, and control midwives will receive smartphones). * should be proficient in english to understand the spoken instructions in the animated videos. inclusion criteria for women in labor: * should be in active labor. * should give informed consent to participate in the study. * should give birth vaginally. the women in labor and their newborn children will be the primary observational units.
effect of high-dose prednisolone (solu dacortin®) treatment on choroidal and optic nerve head blood flow in humans

Conditions: Regional Blood Flow; Optic Disk

Summary: because of their antiinflamatory effects, glucocorticoids are often used to reduce edema in neurologic tissue and to otherwise mitigate the consequences of neural inflammation. for example, high dose prednisolone treatment has been shown to be an effective therapy for different eye diseases including severe graves´ ophthalmopathy and acute optic neuritis. however, contradictory results exists for the influence of high dose prednisolone therapy per se on tissue blood flow. thus, in the current study, we plan to investigate the effect of high dose, short time therapy with intravenous prednisolone in patients with optic neuritis and severe graves´ ophthalmopathy.


Eligibility criteria:
inclusion criteria: * men and women aged between 19 and 65 years, nonsmokers * group a: patients with graves´ ophthalmopathy (moderate to severe and active ophthalmopathy; i.e. clinical activity score \>3 or =3) suitable for high-dose treatment with prednisolone as assessed by an independent ophthalmologist * group b: patients with acute onset of optic neuritis suitable for high-dose treatment with prednisolone suitable for high-dose treatment with prednisolone as assessed by the ophthalmologist * normal laboratory values unless the investigator considers an abnormality to be clinically irrelevant and not to interfere with prednisolone treatment (normal liver blood parameter and hepatitis serology). * ametropy of less than 3 dpt. exclusion criteria: * regular use of medication which could interfere with the study objectives, especially treatment with vasoactive drugs * active peptic ulcer or insulin dependent diabetes mellitus * hepatitis or elevated hepatic blood parameters * abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study * symptoms of a clinically relevant illness in the 3 weeks before the first study day * blood donation during the previous 3 weeks * pregnancy

Keywords: optic nerve head blood flow choroidal blood flow prednisolone graves´ ophthalmopathy optic neuritis
iatrogenic effects of treatment for childhood cancer constitution of a biological samples bank

Conditions: Paediatric Malignancies

Summary: the constitution of a biological samples bank, attached to epidemiological studies cohort f-ccss on iatrogenic effects of treatment of childhood cancer, will identify genetic variants that can modulate the iatrogenic risks of these treatments. the main objective is to provide a biological samples bank to consider, besides the carcinogenic risks, the risk of other iatrogenic diseases in these children, in particular cardiac, cerebrovascular, lung, bone and kidney. these conditions can be very incapacitating and in some cases, fatal. their impact, however, is poorly estimated as occurring in adulthood, they are rarely made in relation to the treatment received in childhood. the overall project is expected to eventually better define the iatrogenic effects prevention strategies for cancer treatment.


Eligibility criteria:
inclusion criteria: * patients treated for a first cancer in childhood * adult patients * signed informed consent * patient insured or enjoying a social security scheme exclusion criteria: * minor patients * under legal protection measure patients * refusal of consent
one year results of switching to aflibercept for persistent diabetic macular edema resistant to bevacizumab

Conditions: Diabetic Macular Edema

Summary: purpose: the aim of this study is to evaluate the functional and anatomical effects of switching from bevacizumab to aflibercept in patients with persistent dme resistant to bevacizumab. methods: patients with dme refractory to bevacizumab (1.25 mg/ 0.05 ml) were subsequently switched to aflibercept (2.0 mg/0.05 ml). the included patients received 5 loading doses of intravitreal aflibercept (2.0 mg/0.05 ml) (eylea; bayer, berlin, germany) given monthly. after the loading dose, aflibercept was injected every 2 months. the follow up duration was one year.


Eligibility criteria:
inclusion criteria: * diabetic patients, older than 18years, * center-involving dme, central macular thickness (cmt) \>300 μm by spectral domain optical coherence tomography (sd-oct) 1 month after the last bevacizumab injection. * the best corrected visual acuity must be better than 0.05 decimal visual acuity (1.3 log mar). only one eye from each patient was included in the study. if both eyes met the inclusion criteria, the eye with worse visual acuity was included. exclusion criteria: * patients were excluded if they had dense media opacity, pregnancy, previous intravitreal steroid therapy. * uncontrolled diabetes mellitus (hba1c ≥ 10%) and prior intraocular surgery (with the exception of uneventful cataract surgery \>6 months prior to conversion). * other exclusion criteria included active proliferative diabetic retinopathy, tractional maculopathy, macular ischemia and other ocular diseases: age-related macular degeneration, central/branch retinal vein occlusion, and glaucoma.
the effect of dual treatment with l-carnitine and magnesium on fatty liver

Conditions: Non Alcoholic Fatty Liver Disease

Summary: the purpose of this study is to determine whether the dual therapy of the amino acid l-carnitine and magnesium have an effect on reducing the liver fat content in patients with non alcoholic fatty liver disease (nafld).

the purpose of this study is to determine whether the dual therapy of the amino acid l-carnitine and magnesium have an effect on reducing the liver fat content in patients with non alcoholic fatty liver disease. the study is an interventional one in which 60 patients who by definition have non alcoholic fatty licer disease (nafld) are divided randomly (double blind) into 2 groups: group 1: "study group". receive a product (flavoured water) which contains l-carnitine an magnesium. group 2: control. receive placebo. regular water. length of trial - 12 weeks. the patients will be followed on a weekly base and variuos parameters will be compared (weight, lipid profile, insulin resistance etc.). "fibrotest" will be used at the beginning of the trial and at the end (week 12) comparing the fat content before and after the treatment.

Eligibility criteria:
inclusion criteria: age\>18, \<80 y evidence to non alcoholic fatty liver disease exclusion criteria: age\ 80 y pregnancy renal failure congestive heart failure active malignancy liver disease - etiology other than non alcoholic fatty liver disease (nafld). hypothyroidism/cushing total prenteral nutrition (tpn) in the last 6 month

Keywords: non alcoholic fatty liver disease lcarnitine amino acid magnesium fat content
prevention of falls in older adults by specific and progressive balance training

Conditions: Quality of Life

Summary: three months of balance training with follow-up 6 and 12 months thereafter.


Eligibility criteria:
inclusion criteria: * over 60 years with either osteoporosis or parkinsons disease exclusion criteria: * under 60 years
herbert screw vs lag screw fixation in anterior mandibular fracture treatment

Conditions: Mandibular Fractures

Summary: 14 patients having recent anterior mandibular fracture divided into two groups. group a has 6 patients and treated using herbert bone screw, and group b has 6 patients and treated using lag screw. clinical follow-up was conducted after 24-hours, one, four, six, and twelve weeks. in addition, a radiographic investigation was performed after twelve weeks to estimate the mean bone density across the fracture line.


Eligibility criteria:
inclusion criteria * patients suffering from recent, uninfected anterior mandibular fracture. * adult patients from 20-60 years old with no gender predilection agreed to present for follow-up visits for a minimum postoperative period of 3 months. * fracture that demands open reduction and internal fixation. exclusion criteria * medically compromised patients contradicting operations. * existence of infection at the fracture line. * pathological fracture. * an old fracture. * completely edentulous patient
mistletoe in treating patients with advanced non-small cell lung cancer who are receiving palliative chemotherapy

Conditions: Lung Cancer

Summary: rationale: mistletoe may help the body build an immune response and may improve quality of life to help patients live more comfortably. purpose: this phase ii trial is studying mistletoe to see how well it works in treating patients who are receiving palliative chemotherapy for stage iiib or stage iv non-small cell lung cancer.

objectives: * determine whether supplemental treatment with mistletoe increases immune function (as determined by total lymphocyte count, eosinophil count, and lymphocyte subset analysis) in patients with stage iiib or iv non-small cell lung cancer receiving palliative chemotherapy. * determine the tolerability of this drug in these patients. * correlate immune function and quality of life in patients treated with this drug. outline: this is an open-label, non-randomized, multicenter study. patients receive mistletoe subcutaneously three times a week for 15 weeks. dose of mistletoe is increased at weeks 2 and 3 and then every 3 weeks until a maximum response is seen, dose-limiting toxicity occurs, or the study ends. quality of life is assessed at baseline and at weeks 3, 6, 9, 12, and 15. projected accrual: not specified

Eligibility criteria:
disease characteristics: * stage iiib or iv non-small cell lung cancer * newly diagnosed disease * planning to receive standard chemotherapy with either carboplatin plus paclitaxel or cisplatin plus gemcitabine * refused or ineligible to participate in experimental chemotherapy clinical trials patient characteristics: age * 18 and over performance status * karnofsky 60-100% life expectancy * not specified hematopoietic * not specified hepatic * not specified renal * not specified other * not pregnant * no aids * able to self-report quality of life * no known allergy to viscum album linnaeus prior concurrent therapy: biologic therapy * no other concurrent mistletoe products chemotherapy * see disease characteristics endocrine therapy * no concurrent steroid or adrenocorticotropic hormone therapy radiotherapy * not specified surgery * not specified other * no concurrent participation in other clinical trials * no concurrent mushroom glucan or proteoglycan extracts * no concurrent thymus extract * no concurrent non-oncologic immunosuppressive therapy (e.g., therapy for rheumatoid arthritis or after organ transplantation)

Keywords: stage iv non-small cell lung cancer stage iiib non-small cell lung cancer
cognitive and behavioral therapy of anxiety in williams syndrome

Conditions: Williams Syndrome; Anxiety

Summary: patients with williams-beuren syndrome are eight times more likely to suffer from anxiety compared to the general population. few therapeutic solutions are proposed to these patients. the objective of this research is to validate a cognitive and behavioral therapy anxiety protocol for patients with this syndrome.

most studies agree that anxiety disorders are more frequent in people with intellectual disabilities that in the general population. williams syndrome (ws) is a rare disease, associated with an anxiety rate 8 times higher than in the general population. the therapeutic solutions proposed in this population remain limited, in particular concerning approaches without the use of medication. the objective of the study is to evaluate the effectiveness of a program of cognitive and behavioral therapies (cbt) in williams syndrome (ws). for this, an aba-type protocol will be used. it consists of evaluating the effectiveness of an interventional program longitudinally, using a single case type study. adults patients with ws and suffering from anxiety will be recruited. they will be enrolled in a program consisting in nine sessions of a psychotherapy program targeting anxiety. there will be a pretherapy visit (day 0), nine sessions of psychotherapy (month 0 to month 5) and a visit 3 month after the end of the therapy (at month 8) : the visit of the end of the research (v10). the expected results will be to validate a psychotherapeutic program for patients with ws suffering of anxiety. this program might be extended to other patients with intellectual disability.

Eligibility criteria:
inclusion criteria: * diagnosis of williams syndrome * complaint about anxiety * 18 years old and more * score of 7 or more at the celf-4 (it is a scale assessing the language) * informed consent signed exclusion criteria: * scoring less than 7 at the celf-4 * hearing impairment * visual impairment

Keywords: williams syndrome anxiety cognitive and behavioral therapy intellectual disability
acute effects of cold exposure on cardiovascular system

Conditions: Cardiovascular System

Summary: this is a randomized controlled human exposure crossover study. investigators aim to assess the acute effects of low temperature exposure on cardiovascular system and the underlying mechanisms.

the investigators will conduct a randomized controlled human exposure crossover study among about 40 healthy young adults in shanghai, china. each subject will be exposed twice: once to the low temperature (15°c) and once to the moderate temperature (22°c) in a chamber for about 2 hours. during the exposure session, each subject will be requested to rest. health examinations will be conducted at baseline immediately prior to exposure, during the period of exposure, and after exposure. health examinations include blood pressure tests and holter monitoring. investigators plan to collect blood and urine samples.

Eligibility criteria:
inclusion criteria: * living in shanghai during the study period; * body mass index \> 18.5 and ≤ 28; * right-handed; * receiving or having received higher education; * with the ability to read and understand chinese smoothly. exclusion criteria: * smoking and alcohol abuse; * current drug and dietary supplements intake; * subjects with allergic diseases, such as allergic rhinitis, allergic asthma, and atopy; * subjects with cardiovascular diseases, such as congenital heart disease, pulmonary heart disease, and hypertension; * subjects with respiratory diseases, such as asthma, chronic bronchitis, and chronic obstructive pulmonary disease; * subjects with chronic diseases, such as diabetes, chronic hepatitis, and kidney disease; * subjects who have a history of major surgery due to cardiovascular, cerebrovascular, respiratory, or neurological diseases; * subjects with neurologic disorders, such as stroke, traumatic brain injury, epilepsy, and schizophrenia; * abnormal spirometry (fev1 and fvc ≤ 75% of predicted and fev1/fvc ≤ 0.65); * subjects with color vision disabilities.

Keywords: low temperature randomized controlled trial cardiovascular system
perioperative hypogonadism in men undergoing radical cystoprostatectomy for bladder cancer

Conditions: Bladder Cancer; Low Testosterone Levels

Summary: the purpose of this study is to examine the relationship between testosterone level changes around the time of radical cystectomy.


Eligibility criteria:
inclusion criteria: * diagnosis of bladder cancer * scheduled to undergo radical cystectomy exclusion criteria: * evidence of advanced metastatic disease, * undergoing cystectomy for non-bladder primary malignancy or bladder cancer type other than urothelial cell * history of breast or prostate cancer * polycythemia, cardiovascular thromboembolism, untreated obstructive sleep apnea, uncontrolled heart failure, or acute coronary event in the past six months

Keywords: radical cystectomy hypogonadism
a 24-week rpms study in real-world setting for enerzair

Conditions: Asthma

Summary: this surveillance was designed as a prospective, open-label, multicenter, single-arm, non-interventional, observational study to evaluate the safety and effectiveness of enerzair inhalation capsule for up to 24 weeks under routine clinical practice.

the two different doses of enerzair inhalation capsule via breezhaler will be prescribed according to the approved label information in korea, and the investigation for any additional diagnostic or monitoring will be not conducted for this study.

Eligibility criteria:
inclusion criteria: 1. adult patients (≥18 years of age) with a physician's diagnosis of asthma, who are prescribed enerzair inhalation capsule (indacaterol acetate/ glycopyrronium bromide/mometasone furoate; 150/50/80, 150/50/160 μg) via breezhaler, as per the approved label information 2. patients who participate in the study after signing the consent form for data collection and use (data privacy icf) after receiving a clear explanation of the objectives and nature of the study from the investigator exclusion criteria: 1. patients who are contraindicated for this medicinal product as described in the precautions for use in the label information (package insert) a. patients with hypersensitivity reaction to this medicinal product or any of its constituents b. because this medicinal product contains lactose, patients with hereditary problems of galactose intolerance, the lapp lactose deficiency or glucose-galactose malabsorption, etc. 2. patients with acute asthma symptoms, including acute episodes of bronchospasm, for which a short-acting bronchodilator is required 3. patients participating in other interventional clinical trials

Keywords: enerzair qvm149 korea