Kornimate/medical-research-clean huggingface dataset:
using acetylcysteine and vitamin e with psoriasis vulgaris

Conditions: Psoriasis Vulgaris

Summary: this study aims to assess the effect of adding n-acetyl cysteine (nac) alone or in combination with vitamin e to conventional therapy in improving the clinical outcome, oxidative stress, and inflammation in patients with mild psoriasis vulgaris

the study will include 60 mild psoriatic patients in the active phase (score \<, =3) using pasi score. the pasi is a widely used instrument that assesses and grades the severity of psoriatic lesions and the patient's response to treatment. they will assigned randomly into 3 groups. each group will contain 20 patients. the first group will receive standard treatment for mild psoriatic patients (topical steroid and salicylic acid), the second group will receive standard treatment for mild psoriasis, plus n acetyl cysteine (600 mg a day) oral, 30 minutes before breakfast, for 8 weeks. the third group will receive standard treatment for mild psoriasis, plus n acetyl cysteine (600 mg a day) oral effervescent sachet,30 minutes before breakfast plus, vitamin e (1000 mg) daily, oral soft gelatin capsule for 8 weeks. pasi=psoriasis area and severity index

Eligibility criteria:
inclusion criteria: 1. adult patients from 18 to 65 years. 2. gender: both males and females. 3. mild psoriatic patients in the active phase (score \< =3) 4. patients diagnosed with mild psoriasis in the active phase (score less than or equal 3) using pasi score. exclusion criteria: 1. inactive psoriasis vulgaris patients. 2. alcohol consumption 3. any other autoimmune diseases. 4. pregnant or lactating women. 5. patients with serious illness and any systemic failure (cardiovascular, renal, or respiratory) 6. patients with major psychiatric or mental illness. 7. intake of any antioxidants in the previous 3 months 8. patients of chronic diseases, like hypertension, heart problems 9. patients with history of bleeding, ulcers, or uncontrollable heartburn. 10. patients taking anticancer medications that can aggravate psoriasis vulgaris such as mercaptopurine, vinblastine, actinomycin, and radiation
pompe telemedicine developmental study

Conditions: Pompe Disease; Glycogen Storage Disease II

Summary: the primary purpose of this study is to: * document the developmental outcomes of individuals with pompe disease treated with long-term enzyme-replacement therapy (ert) through school-age (ages 6-18) using measures of cognitive functioning, academic skills, and speech and language abilities. * investigate possible cognitive processing speed weaknesses using brainbaseline neurocognitive assessment software. * investigate the relationship between behavior and other developmental factors including speech and language ability and cognitive ability. * explore if the use of selected ipad applications may help strengthen cognitive processing speed in children with pompe disease

the study will last approximately 2-3 years. it includes 2-4 visits to duke for developmental assessments. the baseline/year 1 visit may take place at duke (may take 1-2 days) or remotely via ipad. the follow up 1/year 2 visit may take place at duke (1-2 days) or remotely via an ipad, depending upon each child's particular situation.

Eligibility criteria:
inclusion criteria: * age range 6-18 years * diagnosis of classic pompe disease by enzyme or molecular methods * patient, parent, or legal guardian is willing and able to give written informed consent * english speaking child and care giver. exclusion criteria:

Keywords: pompe glycogen storage disease ii telemedicine duke university medical center
left bundle branch pacing versus conventional pacing in atrioventricular block

Conditions: Atrioventricular Nodal Disease

Summary: recently, the concept of physiological pacing has emerged in the clinical practice, in an attempt to prevent the deteriorating effects of right ventricular pacing in the long-term. left bundle branch pacing seems to be a safe procedure with promising results that may prevent intraventricular dyssynchony compared with the conventional right ventricular pacing.

in this prospective, randomized study the outcomes regarding echocardiographic indices of dyssynchrony in left bundle branch versus conventional right ventricular pacing in patients with atrioventricular node disease will be compared in recent years, his pacing has demonstrated better results regarding resynchronization compared to conventional biventricular pacing in trials of 3d mapping. however, technical difficulties that relate to unstable lead positioning or inability in succeeding low pacing threshold have led to low success rates. an alternative site of physiological pacing that could possibly overcome these issues, while maintaining ventricular synchrony is left bundle branch pacing. the lead implantation of lbb pacing is performed using the select secure (3830) pacing lead. the lead is screwed into the interventricular septum, until left bundle branch pacing is achieved. the randomized patients 24 hours after the procedure are echocardiographically evaluated and indices of mechanical dyssynchrony are recorded. follow-up is conducted at 3 months, 6 months and one year post-procedure.

Eligibility criteria:
inclusion criteria: * age\>18 years old * patients with atrioventricular block and ef\>50% with a predicted ventricular pacing rate\>20% * patients with intraventricular septal diameter\>8mm * written informed consent exclusion criteria: * indication for crt or icd device * patients with no subclavian approach, who are candidates for leadless devices * presence of severe tricuspid regurgitation * patients who are candidates for implantation from the right side, as currently the provided tools for left bundle branch pacing fascilitate only left sided pacemaker implantations
efficacy of a simplified modified atkins diet in children with refractory epilepsy

Conditions: Refractory Epilepsy

Summary: one third of children with epilepsy have seizures that are medically intractable. uncontrolled seizures pose a variety of risks to children, including higher rates of mortality, developmental delay and cognitive impairment. epilepsy surgery is not a feasible option for most children with refractory epilepsy. the ketogenic diet and the modified atkins diet have been shown to be effective alternative treatments in children with refractory epilepsy. however, these need parents to be educated, and understand complex instructions of weighing foods and diet preparation. therefore, children with parents with low levels of literacy and poor socioeconomic status have not been able to benefit from these therapies. also, the paucity of trained dieticians and limited availability of labeled foods in resource-constraint settings has made these dietary therapies even more inaccessible. this study aimed to to develop a simple-to-administer variation of the modified atkins diet for use in children with refractory epilepsy and to evaluate the efficacy and tolerability of this simplified modified atkins diet in children with refractory epilepsy in a randomized controlled open-label trial.


Eligibility criteria:
inclusion criteria: 1. age: 2 - 14 years. 2. seizures persisting daily or more than 7 per week despite the use of at least 2 anti-epileptic drugs in appropriate doses and levels (whenever available) in suitable to the syndrome and eeg findings. exclusion criteria: 1. known or suspected inborn error of metabolism: patients with clinical suspicion of metabolic disorder as evidenced by 2 or more of the following- a history of parental consanguinity, prior affected siblings, unexplained vomiting, intermittent worsening of symptoms, recurrent episodes of lethargy, altered sensorium, or ataxia, hepatosplenomegaly on examination with or without 2 or more of the following biochemical abnormalities high blood ammonia (\>80mmol/l), high arterial lactate (\>2 mmol/l), metabolic acidosis (ph \<7.2), hypoglycaemia (blood sugar \<40 mg/dl), abnormal urinary aminoacidogram, presence of reducing sugars or ketones in urine, and positive results on urine neurometabolic screening tests. in such patients, blood tandem mass spectrometry or urine gas chromatography mass spectroscopy (gcms) will be obtained to look for inborn error of metabolism. 2. surgically remediable causes of epilepsy such as tumors, cortical dysplasias, mesial temporal lobe epilepsy etc with refractory focal epilepsy. we will perform mri brain, and short term video-eeg in all patients with focal seizures to look for surgically remediable causes. 3. motivational or psychosocial issues in the family which would preclude compliance 4. systemic illness- chronic hepatic, renal or pulmonary disease

Keywords: refractory epilepsy dietary therapy non-pharmacological therapy simplified modified atkins diet
survey followed by a retrospective chart review to describe the key factors leading to physician's decision to treat patients at high and very high cardiovascular risk with hypercholesterolemia or mixed dyslipidemia with nustendi®

Conditions: Hypercholesterolemia; Mixed Dyslipidemia

Summary: in this study, a survey of office-based cardiologists and lipid management specialists will be conducted on treatment decisions for nustendi® (bempedoic acid 180 mg fixed dose combination \[fdc\] with ezetimibe 10 mg) followed by a retrospective chart review of patients at high and very-high cardiovascular risk with hypercholesterolemia or mixed dyslipidemia who were treated with fdc as add-on to treatment with maximally tolerated statin therapy in routine clinical practice.

the physician survey aims to understand the context of the real-world clinical setting and shed light on the utilization of fdc treatments by the prescribing physicians. the retrospective patient chart review will gain insights in real-world data of the patient's characteristics with a treatment decision for the fdc. no study drugs will be provided or administered as part of this protocol. the objectives of the physician survey are the evaluation of the key factors for the therapy decision for the fdc: * ldl-c levels at therapy decision and goal of ldl-c reduction * relevance of different factors and considerations * considerations of guidelines the objectives of the retrospective patient chart review are to characterize the patients': * demographics * ldl-c levels at therapy decisions * medical history * concomitant diseases * lifestyle modifications

Eligibility criteria:
inclusion criteria: * eligibility criteria for the office-based cardiologists and lipid management specialists are as follows: * more than 10 years of experience in medical practice * for office-based cardiologists: supervision of at least 200 patients at high and very high cardiovascular risk as assessed by the office-based cardiologists with hypercholesterolemia or mixed dyslipidemia. for lipid management specialists: supervision of at least 500 patients at high and very high cardiovascular risk as assessed by the lipid management specialists with hypercholesterolemia or mixed dyslipidemia * working in practices to whom patients were either referred or had direct access to. * availability to share medical files of consenting patients with study personnel (e.g. clinical research associates) by remote quality review * at least 5 patients for the retrospective chart review the inclusion criteria for the patients are as follows: * written informed consent to participate * patients at high and very high cardiovascular risk diagnosed with hypercholesterolemia or mixed dyslipidemia and treated with bempedoic acid 180 mg fixed dose combination with ezetimibe 10 mg (fdc) for at least 4 weeks at the discretion of the physician according to the german label exclusion criteria: * any patient who did not meet all inclusion criteria noted above

Keywords: hypercholesterolemia mixed dyslipidemia nustendi® statin therapy
effect of nicotinic acid on cardiovascular risks indices in polycystic ovary syndrome

Conditions: Polycystic Ovary Syndrome

Summary: niacin will improve postprandial hyperlipidaemia and cardiovascular risks indices via its lipid lowering as well as via pleiotropic effects in patients with polycystic ovary syndrome (pcos).

polycystic ovary syndrome is a common hormone problem in young women and, as a result of it, they can experience irregular periods, reduced fertility, acne and increased body hair. frequently, increased weight is a feature. research suggests that they could have a higher risk of diabetes, high cholesterol and cardiovascular disease such as high blood pressure, angina, heart attack and stroke. the fat from the diet is transported from the stomach into the blood and then taken up by the liver, muscles and fat tissues to store or use as an energy source. delayed removal of fat from the circulation resulting rise of fat after a meal has been known to happen in pcos. high fats after a meal are a strong risk factor for cardiovascular disease. niacin has been in clinical use to lower bad cholesterol and to increase good cholesterol for many years. it has been proved to be effective in reducing risks of heart disease in patients with diabetes. however the effect of niacin on reducing cardiovascular risks and reducing fat level after a meal in pcos has not been studied and this is why we plan to do this research.

Eligibility criteria:
inclusion criteria: * females aged between 18 - 50 years * has polycystic ovary syndrome diagnosed according to rotterdam consensus statement exclusion criteria: * pregnancy/trying to conceive/breast feeding * history of cardiovascular, renal, hepatic and active thyroid disease * history of gout * history of alcohol abuse * history of diabetes * history of allergy to nicotinic acid/laropiprant or food * history of bleeding disorders/active peptic ulcers * patient on antihypertensive medications * patient on anticoagulants * patient on any hormonal replacement or oral contraceptive pills or cholesterol lowering agents * history of smoking more than 15 pack year * unwilling for gp to be informed

Keywords: pcos
acute exacerbation of chronic obstructive pulmonary disease inpatient registry study stage ii

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: the aim of this study is to provide high quality data and give a comprehensive overview of characteristics, clinical features, management and prognosis during exacerbations and stable periods among inpatients with acute exacerbation of chronic obstructive pulmonary disease in real-world china.

objective: the aim of this study is to provide high quality data and give a comprehensive overview of characteristics, clinical features, management and prognosis during exacerbations and stable periods among inpatients with acute exacerbation of chronic obstructive pulmonary disease in real-world china. eligibility criteria: details are shown in the eligibility criteria part. procedures and measurements: at admission, each eligible subject will be given an in-depth interview to collect the demographics, smoking history, medical history, management of disease during stable period, etc. during hospitalization, treatment and auxiliary examination results including laboratory and lung function tests will be recorded if available. to ensure the quality and uniformity of spirometry data, training on performing spirometry will be provided to each study site by professional doctors from central site. at discharge, physicians will record the discharge diagnoses and clinical outcomes including death, intensive care unit admission, chronic obstructive pulmonary disease assessment test (cat) score and total direct cost for each participant. during follow-ups, clinical outcomes including death and exacerbation events, change of medication, new-developed complications, auxiliary examination results, and economic burden will be collected.

Eligibility criteria:
inclusion criteria: * ≥18 years of age * hospitalized with main diagnosis of acute exacerbation of chronic obstructive pulmonary disease (aecopd) exclusion criteria: * refusing to sign informed consent forms * participating in clinical trials or intervention studies of drugs * diagnosed as active pulmonary tuberculosis, or acute left heart failure

Keywords: registries demography therapeutics disease management mortality
is there a metabolic effect of cinnamon on hba1c, blood pressure and serum lipids in type 2 diabetes mellitus?

Conditions: Type 2 Diabetes Mellitus

Summary: the aim of the study is to assess whether dietary supplementation of cinnamon (cinnamon cassia) has the potential to improve hba1c, blood pressure and serum lipid measurements in patients with type 2 diabetes mellitus.

the study will be conducted for 3 months (12 weeks) with 58 individuals diagnosed with type 2 diabetes mellitus. the randomisation will be carried out by using a randomisation list. cinnamon bark (cinnamon cassia) and starch flour (placebo) capsules will be purchased from a local pharmaceutical company in uk; these are freely available for over the counter use. each capsule contained either 500 mg of cinnamon powder or starch flour. the cinnamon and placebo (starch flour) capsules will be packaged in a non transparent plastic bags. the patients will be randomly allocated into the two groups of: group 1: placebo control group group 2: cinnamon group patients in both placebo and cinnamon groups will receive treatment similar to the treatment they would normally receive from their respective nhs or primary care trust for 12 weeks. data collection: after the randomisation the subjects will be scheduled to visit the clinic at 0 weeks, 6 - 7 weeks and 12 weeks from the beginning of the study. during every visit (week 0, weeks 6 - 7 and week 12) a 3-day diet diary will be collected and the intake of total calories, fats, carbohydrates, proteins and fibre will be determined. compliance with the diet will be monitored by individual discussions at each clinical visit with dietician and compared with the diet diary. the anthropometric measurements of body weight, height, waist and hip circumferences will be measured before the trial (week 0), during the trial (weeks 6 - 7) and after the trial (week 12) period. the recorded clinical measurements of blood profiles include hba1c level, fasting plasma glucose concentration and serum lipid profiles including serum total cholesterol, high density lipoprotein (hdl), low density lipoprotein (ldl) and serum triglycerides, systolic and diastolic blood pressures will be measured at the baseline (week 0) and at 12 weeks during the study period.

Eligibility criteria:
inclusion criteria: 1. patients diagnosed with type 2 diabetes mellitus 2. aged over 18 years, either sex 3. hba1c level more than 7% 4. patients treated only with oral anti-diabetic drugs or diet exclusion criteria: 1. patients with severe health problems including renal disease, liver disease, cardiovascular disease and other chronic ill health conditions 2. patients with mental health problems 3. patients treated with insulin therapy 4. patients refused to give informed consent 5. pregnant and lactating women 6. patients taking cinnamon supplements and other herbal supplements known to be effective

Keywords: blood sugar cholesterol cinnamon hba1c
solution: study of oral liprotamase unit-matched therapy of non-porcine origin in patients with cystic fibrosis

Conditions: Exocrine Pancreatic Insufficiency; Cystic Fibrosis

Summary: liprotamase powder is a non-porcine, soluble and stable mixture of three digestive enzymes including lipase, protease, and amylase. the purpose of the present study is to provide additional efficacy and safety data compared to approved, porcine-derived, enterically-coated and encapsulated pancreatic enzyme replacement therapy. the primary efficacy endpoint of the study will be comparative efficacy measured as the change in the coefficient of fat absorption (cfa) in cystic fibrosis patients with exocrine pancreatic insufficiency (epi). liprotamase is stable in stomach and digestive fluids allowing administration in a variety of convenient formulations and with a number of foods without enteric coating.

porcine derived enzymes are used for pancreatic enzyme replacement therapy in patients with cystic fibrosis (cf). liprotamase is a biotechnology-derived enzyme replacement without enteric coating. this is an open-label, assessor blind, parallel group, multicenter, international trial to evaluate the noninferiority of liprotamase and pancrelipase in cf patients aged ≥7 years with pancreatic insufficiency. subjects were randomized to liprotamase or pancrelipase, dose-matched to pre-study lipase doses. the lower bound of the 95% confidence interval (ci) for noninferiority was -15% for treatment difference in change from baseline coefficient of fat absorption (cfa).

Eligibility criteria:
inclusion criteria: * diagnosis of cystic fibrosis based on presentation, genotype and/or sweat chloride * fecal elastase \<100 mcg/g stool * minimum coefficient of fat (cfa) at screening while on stable pert therapy * good nutritional status exclusion criteria: * history or diagnosis of fibrosing colonopathy * distal intestinal obstruction syndrome in 6 months prior to screening * receiving enteral tube feedings * chronic diarrheal illness unrelated to pancreatic insufficiency * liver abnormalities, or liver or lung transplant, or significant bowel resection * forced expiratory volume in 1 second (fev1) \<30%
the effect of vitamin d substitution on the development of chronic pancreatitis

Conditions: Chronic Pancreatitis

Summary: acute pancreatitis (ap) may develop to chronic pancreatitis (cp). in finland, the ethiology is alcohol in about 80% of the cases. several symptoms lower the quality of life in cp patients, including abdominal pain, exocrine and endocrine pancreatic insufficiency. recently, the investigators and others have found that vitamin d may protect from the formation of fibrosis on cellular level. the investigators hypothesized that after the first ap they may be able to protect the formation of fibrosis leading to cp with vitamin d, and designed this rct. the aim is to study whether the investigators can prevent cp with vitamin d substitute. in this randomized controlled patient study, the patients after their first ap are randomized to have either a normal recommended (10 μ) or a largest safe dose (100 μg). of vitamin d substitute daily. the patients are examined by mri/mrcp imaging and laboratory tests at the baseline after recovery from ap and yearly then after. primary endpoint is the development of parenchymal changes possibly related to fibrosis. secondary endpoints are the development of cp with mannheim criteria, cp related complications and mortality. the first analysis will be done after 7 years. the enrollment will begin 26.9.2016


Eligibility criteria:
inclusion criteria: * first alcohol induced acute pancreatitis * willing to participate in a 3 year rct exclusion criteria: * renal failure * hypercalcemia * high serum levels of vitamin d * unwilling to participate

Keywords: chronic pancreatitis vitamin d pancreatitis pancreatic stellate cell rct
ocular hypertension treatment study (ohts)

Conditions: Ocular Hypertension; Glaucoma

Summary: the ocular hypertension treatment study is a multi-center clinical trial sponsored by the national eye institute, designed to determine the efficacy and safety of topically administered eye lowering medication


Eligibility criteria:
inclusion criteria: * qualifying iop in at least one eye of each participant must be more than or equal 24 mmhg but less than or equal to 32 mm hg calculated from two separate consecutive determination taken at least 2 hours, but not greater than 12 weeks apart. * normal and reliable 30-2 humphrey visual fields in both eyes. * normal optic disc in both eyes on clinical examinations and stereoscopic photographs as determined by the optic disc reading center. exclusion criteria: * visual acuity worse than 20/40 in either eye on qualifying exam. * previous intraocular surgery: laser trabeculoplasty, laser iridotomy, filtering surgery, combined cataract extraction/filtering procedures, penetrating keratoplasty and retinal detachment repair.