Kornimate/medical-research-clean huggingface dataset:
high-dose statin combined with telmisartan vs amlodipine on glucose metabolism in ascvd patients with ifg and hypertension

Conditions: ASCVD; Impaired Fasting Glucose; Hypertension

Summary: this study will evaluate the effect of high-dose rosuvastatin combined with telmisartan or amlodipine on glucose metabolism in ascvd patients with impaired fasting glucose and hypertension.


Eligibility criteria:
inclusion criteria: 1. written informed consent 2. aged 19 to 75 years 3. patients with ascvd requiring high-intensity statin therapy (in accordance with the clinical ascvd diagnostic criteria in the 2013 acc/aha guideline) - coronary artery disease * acute coronary syndrome * history of myocardial infarction (mi) * stable or unstable angina * history of coronary revascularization * stroke or transient ischemic attack (tia) * peripheral arterial disease, history of peripheral arterial revascularization 4. those who are taking antihypertensive drugs, or sbp \> 140mmhg or dbp \> 90mmhg on the left side 5. high-risk group (except for gestational diabetes) who has not been diagnosed with diabetes before, and who falls under one of the following criteria: * impaired fasting glucose (ifg): 100-125 mg/dl (5.6-6.9 mmol/l) * impaired glucose tolerance (igt): plasma blood glucose 140-199mg/dl (7.8 to 11.0 mmol/l) 2 hours after oral administration of glucose 75g * hba1c: 5.7-6.4% exclusion criteria: 1. those who are treated with secondary hypertension or malignant hypertension 2. uncontrollable diabetes with hba1c ≥ 10% 3. total cholesterol ≥ 300mg/dl 4. fasting ldl-c ≤ 70 mg/dl 5. fasting triglyceride ≥ 500 mg/dl 6. history of muscular disease or rhabdomyolysis due to use of statin 7. hypersensitive to statin or arbs 8. contraindications stated in the spc of telmisartan or rosuvastatin including the following: * severe renal disease (crcl \< 30ml/min: cockcroft-gault formula or estimated gfr (mdrd) \< 30ml/min/1.73m2) * alt, ast \> 3x uln or history of active liver disease * cpk \> 3x uln * hyperkalemia with serum k \> 5.5 meq/l 9. those who are participating in clinical trials of other investigational products 10. those who cannot discontinue all other treatment for hypertension or hyperlipidemia than the investigational products, and concomitant medications and supplements that can affect the therapeutic effect of hypertension and hyperlipidemia during the trial period 11. other than the above who is deemed to be ineligible to participate in the trial by investigator
the effect of low-intensity blood flow restriction therapy on the management of acute ankle sprains

Conditions: Ankle Sprain 1St Degree; Ankle Sprain 2Nd Degree; Musculoskeletal Injury

Summary: the primary objective of this study is to evaluate the feasibility of implementing bfr in the rehabilitation treatment of isolated ankle sprains as well as to evaluate the clinical benefits of bfr when compared to standard treatment. this study will evaluate the efficacy of using bfr therapy for the treatment of acute grade i and ii ankle sprains. the investigators will evaluate clinical outcomes of range of motion (rom) and strength testing of ankle dorsiflexion, plantarflexion, inversion, and eversion. this will be a small, randomized control trial study. the investigators will enroll a total of 40 participants, 20 participants will undergo standard physical therapy for isolated lateral ankle sprains and 20 participants will undergo bfr therapy for an isolated lateral ankle sprain. patients will be randomized into control and experimental group via block randomization.


Eligibility criteria:
inclusion criteria: * patients will include english speaking student athletes aged 18 and older with clinical diagnosis of an isolated grade i or ii lateral ankle sprain exclusion criteria: * history of dvt/pe, clotting disordered, peripheral arterial disease, hypertension (bp\>140/90), coronary artery disease, or pregnancy

Keywords: blood flow restriction ankle sprain
athena: natural history of disease study in alport syndrome patients

Conditions: Alport Syndrome Patients With eGFR Between 45-90 ml/Min/1.73 m2

Summary: there is limited published clinical data about the natural history of renal disease in alport syndrome. the rg012-01 study will collect data to characterize the progression of renal dysfunction in alport syndrome patients. patients with a confirmed diagnosis of alport syndrome who have qualifying gfr will be considered for enrollment. the sequential sampling of subjects' urine and/or blood will allow an assessment of the rate of change of established clinical endpoints, such as gfr and/or the rate of change of other renal biomarkers (proteinuria and β-2 microglobulin) in subjects whose renal function is steadily declining. the identification of surrogate markers that track the decline of renal function and could correlate with time to end-stage renal disease (esrd) is a key goal of the natural history study.

this is a natural history study, designed to collect data from patients with alport syndrome with qualifying gfr. assessments and blood and urine sample collection will be performed at baseline and every 12 weeks thereafter, for up to 120 weeks. scheduling of clinic visits will take in to consideration the timing of standard of care (soc) visits. alternative arrangements may be made to enable subjects to schedule a home nurse visit for study procedures instead of certain clinic visits. remaining blood and urine aliquots will be stored and may be used in the future for the discovery, analysis, verification and/or validation of other biomarkers or test for renal disease. the samples will be kept for up to five years. each sample will be identified only by it's barcode number and will not be individually identifiable.

Eligibility criteria:
inclusion criteria: * able to understand and comply with the requirements of the study and willing and able to provide written informed consent; pediatric subjects must be able to provide assent; * age 12-65 years of age; * confirmed diagnosis of alport syndrome (clinical, histopathologic and/or genetic diagnosis of alport syndrome); * egfr 45-90 ml/min/1.73 m2, within 30 days of enrollment. exclusion criteria: * use of investigational drugs at the time of enrollment, or within 30 days, or 5 half-lives of enrollment, whichever is longer; * ongoing chronic hemodialysis therapy and/or renal transplant recipient.

Keywords: alport syndrome kidney disease
ecalmist versus insure in preterm infant < 32 weeks,multicenter, multinational rct

Conditions: Respiratory Distress Syndrome

Summary: minimally invasive surfactant therapy via a small vascular catheter - ecalmist (early cpap and large volume minimal invasive surfactant therapy) versus insure (intubate, surfactant extubate) in preterm infants with respiratory distress syndrome (rds): a prospective randomized clinical trial.

after meeting all the inclusion criteria, eligible infants will be randomized to receive surfactant either through the ecalmist or the insure methods. the attending neonatologist or neonatal team will have full discretion to decide when to intubate and when to extubate or wean the infant off the ventilator or ncpap. general guidelines for reintubation include persistent ph\ 65 mmhg, very frequent apnea (\>2-3/hour of apneic or bradycardic spells not responsive to corrective therapy), frequent desaturations \>3/hour not responding to increase in fio2 or increase in fio2 to 100%), or apneas requiring prolonged ppv. for the purpose of the study a successful outcome for the primary objective will have occurred if the infant has not been reintubated and ventilated during the initial 3 days of life.

Eligibility criteria:
inclusion criteria: all should apply: * newborn less than 32 weeks gestation at birth * postnatal age \< 24 hrs of life * clinical diagnosis of rds * spontaneously breathing on ncpap * clinical decision to give surfactant. exclusion criteria: * lack of parental consent. * need for mechanical ventilation * major congenital malformation

Keywords: ecalmist insure cpap ventilation vascular catheter
hemopatch performance evaluation: a prospective observational registry

Conditions: Dura Mater Nick Cut or Tear; Hemostatis; Air Leakage; Body Fluid Leakage

Summary: to assess the clinical performance and safety of hemopatch sealing hemostat in a post-marketing setting in cardiovascular, thoracic, urologic, neurological, and other general surgical procedures.


Eligibility criteria:
inclusion criteria: * male or female patients of any age * patients who had undergone open or minimal invasive surgical (mis) procedures requiring the use of a patch to achieve dura repair, hemostasis, or control of leakage of air or other body fluid when pressure, ligature or other conventional procedures had been ineffective or impractical and where use of hemopatch was deemed appropriate by the surgeon according to its ifu in the following organ systems: 1. hepato-biliary (liver, pancreas, gallbladder) 2. general surgery (in thyroid and other regions) 3. cardiovascular (heart and vessels) 4. thoracic (lung and mediastinum) 5. urological (kidney, prostate, and bladder 6. neurological (dura mater, brain and spinal cord) * provision of written informed consent/assent, as applicable, up to 72 hours after the date of surgery exclusion criteria: * patients with known hypersensitivity to bovine proteins or brilliant blue * patients who had intraoperative pulsatile or severe bleeding at the target application site (tas) * patients who had an active infection at the tas
dopamine agonist treatment of non-functioning pituitary adenomas

Conditions: Pituitary Neoplasms; Adenoma

Summary: due to lack of hormone overproduction in non-functioning pituitary adenomas (nfpas), only the symptomatic adenomas or large adenomas with proven growth and risk for symptoms in near future will undergo pituitary surgery. the remaining adenomas are monitored regularly. operation of these large adenomas will rarely remove all tumour tissue, and there is also a risk of worsening of pituitary function. often, adenomas with the highest growth potential are operated several times and some also need radiation therapy, providing additional risk for pituitary failure. unlike some of the hormone-producing adenomas, there is no established pharmacological treatment for nfpas. however, there are a few non-randomized studies suggesting that treatment with dopamine agonists may slow growth, and also induce tumour shrinkage. at present, cabergoline is the dopamine agonist most widely used in the treatment of pituitary adenomas secreting prolactin. aim is to study the effect of medical treatment with cabergoline in non-functioning pituitary adenomas on the change in tumour volume.


Eligibility criteria:
inclusion criteria: * a previously untreated non-functioning pituitary macroadenoma (largest diameter ≥ 10 mm) with either demonstrated growth on repeated mri scans or ≤ 2 mm distance to chiasma opticum, or: * a residual non-functioning pituitary adenoma after surgery (largest diameter ≥ 5 mm) that is either extrasellar and/or with documented growth after surgical treatment of a non-functioning pituitary macroadenoma exclusion criteria: * clear indication for surgery at the time of inclusion * previous radiation therapy * pituitary surgery the last 6 months * previous apoplexy/bleeding in the adenoma * pregnancy or lactation * contraindications for cabergoline treatment (known cardiac valvular disease, known pulmonal, pericardial or retroperitoneal fibrosis, clinical significant liver insufficiency, use of medications that interact with cabergoline * unfit to participate due to any other reason

Keywords: dopamine agonists cabergoline
brain indices of risk for posttraumatic stress disorder (ptsd) after mild traumatic brain injury (mtbi)

Conditions: PTSD

Summary: this is a prospective, longitudinal cohort study to evaluate the associations between indices of brain structure and function (measured at baseline, as soon as possible after injury) and course of post-traumatic stress disorder (ptsd) symptoms. subjects will be service members who have sustained mild traumatic brain injury (classified as either "impact-induced mtbi" or "blast-induced mtbi"; n = 100 completers) or an extracranial injury (eci) with no evidence of traumatic brain injury (tbi) (n = 100 completers). subjects will complete an assessment battery at baseline and 6 months later that includes (1) structural magnetic resonance imaging (mri) and diffusion tensor imaging (dti) derived from a 3-tesla magnet; (2) event-related brain potentials (erps) derived from brain electrical activity; (3) neurocognitive tests; and (4) neurological soft signs (nss). specific indices of brain structure and function derived from these assessments are hypothesized to demonstrate a significant relationship with course of ptsd symptoms, which will be measured at baseline, 3 months, and 6 months.


Eligibility criteria:
inclusion criteria: 1. injured while deployed or stateside 2. must be diagnosed tbi positive or certified as tbi negative by a licensed medical practitioner using department of defense (dod) criteria 3. for mtbi subjects, an initial score of 13-15 on the glasgow coma scale 4. aged 18-50 5. defense enrollment eligibility reporting system (deers) eligible exclusion criteria: 1. unable or unwilling to provide informed consent and health insurance portability and accountability act (hipaa) authorization ("unable" includes cases in which the potential subject cannot read and understand english well enough to provide informed consent) 2. penetrating head injury 3. medical chart reveals a history of significant neurological condition(s) (reviewed on a case by case basis) 4. diagnosis with or undergoing treatment for an illness that could affect brain function (reviewed on a case-by-case basis) 5. history of major psychiatric condition(s) that interfere with daily functioning as revealed in the medical chart or by the structured clinical interview for dsm-iv axis i disorders (scid) 6. record of drug or alcohol abuse or dependence in the past six months as documented in medical history review 7. medical chart or scid reveals current or lifetime ptsd diagnosis related to non-combat life events that occurred prior to most recent deployment

Keywords: ptsd mtbi mild tbi extracranial injury eci brain indices
observational study to evaluate levomethadone safety and effectiveness in subjects under opioid maintenance treatment

Conditions: Opioid Addiction

Summary: multicentre, prospective, observational, non-interventional, open- ended trial, collecting data from male and female patients aged ≥ 18 years, with a diagnosis of opioid addiction according to icd-10 (f11.2), treated with therapeutic doses of levomethadone according to the routine medical practice.

multicentre, prospective, observational, non-interventional, open- ended trial, collecting data from male and female patients aged ≥ 18 years, with a diagnosis of opioid addiction according to icd-10 (f11.2), treated with therapeutic doses of levomethadone according to the routine medical practice. the study is divided in two different consecutive parts: * part 1 \[from informed consent form (icf) to last data collected at v4\]: patients enrolled are receiving levomethadone maintenance treatment according to clinical practice. * part 2 (after v4 up to fu): patients are in opioid maintenance treatment with any drug (including levomethadone) according to clinical practice. the maximum duration on-study for a patient will be 405 days \[from icf signature (-30 days from v1) to fu (=360 + 15)\]. this study is an open-ended trial. this means that for the enrolment and for the study, no maximum duration has been established. the study, which is a voluntary post authorization safety study (pass), will be carried out on approximately 10 centers in italy. the objectives are to provide further data on the safety profile after long term use and effectiveness of levomethadone, administered according summary of product characteristics (smpc) and in a real word clinical setting, in opioid-addicted patients undergoing maintenance treatment. safety will be assessed throughout all the study and safety data will be described and analysed based on adverse drug reactions and corrected qt (qtc) prolongation at 12-lead electrocardiogram (ecg), where available. the effectiveness outcomes are the evaluation of levomethadone maintenance treatment according to investigator's judgment at v4(180 days), based on different questionnaires and assessment.

Eligibility criteria:
inclusion criteria: * male and female patients, aged ≥ 18 years; * patients with a diagnosis of opioid addiction according to icd-10 (icd 10 f11.2); * opioid-addicted patients initiating or currently undergoing a maintenance treatment with levomethadone as part of their routine clinical care and according to the approved smpc; * patients or legal guardian when applicable must provide their written informed consent to participate in the study. exclusion criteria: * inability to understand study procedures; * any contraindication stated in the smpc for the administration of levomethadone according to investigator's judgment; * patients currently participating in any other clinical trial.

Keywords: addiction opioid addiction levomethadone methadone opioid maintenance treatment
exocrine pancreatic insufficiency's prevalence in active crohn's disease

Conditions: Crohn Disease

Summary: this study aims to assess the prevalence of exocrine pancreatic insufficiency (epi) in a population of patients with active crohn's disease. studies already describe a prevalence rate around 18-66%. in this multicentric prospective study, we plan to compare epi's prevalence at week 0 and week 14 of an induction phase of a biological therapy. the biological therapy will be initiate for an active crohn's disease. secondary outcomes will be: malnutrition's prevalence, and crohn's disease activity level.


Eligibility criteria:
inclusion criteria: * age of 18 years or more * crohn's disease diagnosed for more than 3 months. * active crohn's disease : cdai score \> 150 + \[crp \> 5 mg/l or faecal calprotectin \> 250mcg/g or endoscopic lesion or mri lesion\] * indication of a biological therapy (anti-tnfα, vedolizumab ou ustekinumab). exclusion criteria: * crohn's disease that doesn't fit the previous criteria * extended resection of small intestine (\>40cm) * chronic pancreatitis diagnosed before inclusion * contraindication to biological therapy (anti-tnfα, vedolizumab ou ustekinumab) * pancreatic enzyme replacement therapy * pregnant or breastfeeding woman * patient under the protection of a conservator
to-cherish: trajectory of cardiovascular ageing, its determinants and impact on health

Conditions: Cardiac Ageing

Summary: specific aim 1: to determine longitudinal changes in cv ageing (changes in cv imaging) over time. hypothesis: there are differences in rates of cv ageing over time. specific aim 2: to study determinants of cv ageing to assess how biological pathways affect cv ageing by studying the relationships between biological signatures measured in longitudinal biospecimens are associated with cv ageing. hypothesis: antecedent biological markers are associated with progression of cv ageing. specific aim 3: to determine the impact of cv ageing progression on the development of clinical cvd and the overall physical, cognitive and functional health of the elderly. hypothesis: those with stable cv imaging phenotypes have lower incidence of clinical cvd and also better overall health in ageing, compared to those with rapid deterioration (unhealthy cv ageing).

in singapore, elderly residents aged 65 years and above make up 10.5% of our population and this is expected to double in 2030 (singapore department of statistics, ministry of manpower, registry of birth and deaths, september 2014). cardiovascular diseases account for the majority of disability-adjusted life years by broad cause group, accounting for 20% of 399,675 life years lost due to mortality and ill-health in 2010 (source: estimates from the singapore burden of disease study 2010). while chronological ageing is inevitable, a clear understanding is needed as to how ageing becomes a critical risk component of cvd for some individuals, and the mechanisms through which ageing results in such a vulnerable phenotype that leads towards clinical cvd. following that, clinical tools and clinical guidelines to reduce cardiovascular disease and other health burdens contributed by ageing may be formulated. such strategies may potentially reduce burdens and cost of healthcare provision to the ageing population. our proposal will generate data that identifies functional and structural changes in the cardiovascular system that occur in during ageing. using a longitudinal design, this research will provide high quality evidence that distinguishes healthy from unhealthy cardiovascular ageing, and reveal determinants and impact of cv ageing over time on cvd and associated health outcomes.

Eligibility criteria:
inclusion criteria: * \>= 21 years old exclusion criteria: * unable to provide written informed consent to participate in the study

Keywords: echocardiogram mri/mrs
ivig versus plasmapheresis in the treatment of guillian barrie syndrome patients

Conditions: Guillain-Barre Syndrome

Summary: in this study, the investigators address the question: whether treatment with ivig is superior to treatment using plasmapheresis for functional recovery of patients with gbs? recovery was quantified using: the changes in the a-clinical grading scale mrc ( medial research council sum score ) and b-overall neuropathy limitations scale as the primary outcome and the changes in neurophysiological study 3 months after treatment as a secondary outcome. this information will be used to evaluate which treatment is more beneficial to gbs patients.

guillain-barré syndrome (gbs) is an inflammatory disease of the pns and is the most common cause of acute flaccid paralysis, with an annual global incidence of approximately 1-2 per 100,000 person-years. patients with gbs typically present with weakness and sensory signs in the legs that progress to the arms and cranial muscles, although the clinical presentation of the disease is heterogeneous and several distinct clinical variants exist. diagnosis of gbs is based on the patient's history and neurological, electrophysiological, and cerebrospinal fluid (csf) examinations. electrophysiological studies: provide evidence of peripheral nervous system (pns) dysfunction and can distinguish between the subtypes of gbs: acute inflammatory demyelinating polyradiculoneuropathy (aidp), acute motor axonal neuropathy (aman), and acute motor-sensory axonal neuropathy (amsan). disease progression can be rapid, and most patients with gbs reach their maximum disability within 2 weeks. about 20% of patients with gbs develop respiratory failure and require mechanical ventilation. cardiac arrhythmias and blood pressure instability can occur owing to the involvement of the autonomic nervous system. immunomodulatory therapy should be started if patients are unable to walk independently for 10 m. evidence on treatment efficacy in patients who can still walk independently is limited, but treatment should be considered, especially if these patients display rapidly progressive weakness or other severe symptoms such as autonomic dysfunction, bulbar failure, or respiratory insufficiency. clinical trials have demonstrated a treatment effect for intravenous immunoglobulin (ivig) when started within 2 weeks of the onset of weakness and for plasma exchange when started within 4 weeks.

Eligibility criteria:
inclusion criteria: * age: 18-70 years old, * onset: recent onset of gbs through the first 2 weeks. * gender: male or female inclusion criteria. exclusion criteria: * patients with metabolic disorders, or malignancy, * other causes of peripheral neuropathy

Keywords: ivig / plasmapheresis and guillain-barre syndrome