Kornimate/medical-research-clean huggingface dataset:
pharmacokinetics and safety of desvenlafaxine in korean healthy subjects following single and multiple oral doses of desvenlafaxine succinate sustained release tablet

Conditions: Major Depressive Disorder

Summary: to evaluate the pharmacokinetics and safety of single dose and multiple doses of desvenlafaxine in korean healthy subjects and compare to westerners.


Eligibility criteria:
inclusion criteria: * healthy male and/or female subjects * between the ages of 18 and 55 years, inclusive * body mass index (bmi) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs) exclusion criteria: * elevated risk of suicide, in the opinion of the investigator or expert consultant * pregnant or nursing females * females of childbearing potential who are unwilling or unable to use an acceptable method of contraception

Keywords: pharmacokinetics safety desvenlafaxine korean healthy subjects
topical antibiotic therapy to reduce infection after operative treatment of fractures at high risk of infection: tobra

Conditions: Post Operative Surgical Site Infection

Summary: the overall objective is to compare the effect of vancomycin and tobramycin powder combined (treatment) to vancomycin powder (control) in the reduction of post-fixation infections of tibial plateau and tibial pilon fractures at high risk of infection (collectively considered the "study injuries").

specific aim 1: compare the proportion of deep surgical site infections (ssi) of the study injury within 182 days of definitive fracture fixation surgery in patients allocated to receive a combination of local vancomycin and tobramycin powders compared to patients allocated to local vancomycin powder. sensitivity analyses: a series of sensitivity analyses will be conducted to look at alternative measures of deep ssi under specific aim 1. these sensitivity analyses will consider the following alternative end points of deep ssi: infection by gram-negative bacteria, infection by gram-positive bacteria, polymicrobial pathogenic infections, culture negative infections, and cellulitis/skin infections. specific aim 2: to compare the safety of treatment with a combination of local vancomycin and tobramycin versus vancomycin powder alone as measured by the proportion of antibiotic resistance in each arm.

Eligibility criteria:
inclusion criteria: 1. tibial plateau or tibial pilon fractures that is treated operatively with plate and screw fixation and at least one of the following characteristics indicative of higher risk of infection: 1. initially treated with an external fixation and treated definitively more than 3 days later after swelling has resolved. 2. any open type i, ii, or iiia fracture, regardless of timing of definitive treatment. 3. tibia fracture is associated with ipsilateral leg compartment syndrome and fasciotomy wounds. 2. patients ages 18 through 80 years. exclusion criteria: 1. study injury is already infected at time of study enrollment. 2. definitive fixation of the study injury prior to enrollment in the study. 3. the patient never receives study fixation. 4. massive myonecrosis from ipsilateral leg compartment syndrome. 5. currently pregnant. 6. severe problems with maintaining follow-up (e.g. patients who are homeless at the time of injury, those who are intellectually challenged without adequate family support, or are unwilling to provide phone and address contact information). 7. patients with allergies, drug administration reactions, or other sensitivities to vancomycin (such as a history of redman's syndrome). 8. patients with allergies, drug administration reactions, or other sensitivities to tobramycin or other aminoglycosides.

Keywords: surgical site infection risk prevention bacterial species type and antibacterial sensitivities
pelvic fixation and fusion during multilevel spinal surgery

Conditions: Spinal Fusion; Deformity of Spine

Summary: paula aims to collect data on the safety, performance, and effectiveness of ifuse bedrock granite (granite) in patients who have spinal fusion surgery with pelvic fixation/ fusion.

paula is a multicenter, open label, single-arm observational clinical study consisting of prospective and retrospective study cohorts. the goal of the study is to collect data on the safety, performance, and effectiveness of granite.

Eligibility criteria:
inclusion criteria: 1. ≥ 18 years of age at screening. 2. patient is scheduled for spinal fusion with pelvic fixation/fusion using ifuse bedrock granite 3. patient is willing and able to provide written informed consent exclusion criteria: 1. any known anatomic issues or permanent implants already in the pelvis that could interfere with placement of the study device(s) 2. prominent neurologic or uncontrolled psychiatric condition that would interfere with study participation 3. known allergy to titanium or titanium alloys 4. current local or systemic infection that raises the risk of surgery 5. currently pregnant or planning pregnancy in the next 2 years 6. known or suspected active drug or alcohol abuse, including opioids 7. patient is a prisoner or ward of the state 8. patient is enrolled in an investigational clinical trial related to the spine
safety and efficacy study of novel gene therapy zm-01 for x-linked retinoschisis patients

Conditions: X-linked Retinoschisis

Summary: this trial is meant to evaluate the safety and efficacy of zm-01 of x-linked retinoschisis. unilateral intravitreal injections (ivt) will be given into the subject's study eye.

x-linked retinoschisis (xlrs) is a rare, inherited retinal disease caused by mutations in the rs1 gene. individuals affected by xlrs often experience progressive visual impairment from a young age, potentially leading to legal blindness. there is currently no established clinical treatment available. we developed an innovative adeno-associated virus (aav)-based gene therapy for individuals with xlrs. six to nine subjects with xlrs received a single unilateral intravitreal injection of zm-01 at ascending doses.

Eligibility criteria:
inclusion criteria: subjects who meet all of the following criteria will be enrolled into the study 1. diagnosis of x-linked retinoschisis consistent with the presence of rs1 gene mutation 2. male, aged between 3 and 18 years old, in overall good health except for xlrs condition 3. capable of undergoing visual and retinal function assessment. 4. the visual acuity of the study eye not better than: 0.4 (68 etdrs letters equivalent) 5. no carbonic anhydrase inhibitors have been used at present and for 3 months before treatment 6. laboratory tests meet the following criteria: 1. hemoglobin ≥ 11.0 g/dl 2. white blood cell counts ranged from 3,300 to 12,000 cells /mm³; 3. platelet count 125,000-550,000 /mm³; 4. alanine aminotransferase (alt) is not higher than 1.5 times the upper limit of the normal range of laboratory tests; 5. serum creatinine was no higher than 1.1 times the upper limit of the normal range for laboratory tests; 6. prothrombin time (pt) ≤14.5 seconds and partial thromboplastin time (ptt) ≤ 36.0 seconds. 7. willing to discontinue aspirin, aspirin-containing products, and any other medications that may alter clotting function at least 7 days before dosing. 8. be able to understand and sign informed consent. exclusion criteria: subjects who meet any of the following exclusion criteria before enrollment were excluded from the study 1. previously received any aav gene therapy 2. the following mutations in rs1 gene: r141h, c59s or c223s 3. pre-existing eye conditions that cause severe vision loss or increase the risk of intravitreal injections (e.g., advanced glaucoma, uveitis, or severe retinal detachment) 4. ocular diseases in which there is opacity of the lens, cornea, or other media, hindering adequate observation and examination of the retina 5. use anticoagulant or antiplatelet drugs within 7 days before dosing 6. use any experimental drug within 3 months prior to registration 7. presented any situation that causes the investigator to believe the subject might not adhere to the study protocol or that participation might pose an unacceptable risk to the subject

Keywords: gene therapy aav rs1
a study of safety and efficacy of topiramate in male patients with abdominal obesity

Conditions: Obesity

Summary: the purposes of this study are to compare the effects of topiramate and placebo on abdominal visceral fat accumulation at 6 months and to evaluate the safety of topiramate for up to 12 months of continued treatment in male patients with abdominal obesity.

topiramate is not approved for the treatment of obesity. this study is a 6-month randomized, double-blind placebo-controlled study, followed by a 6-month open-label extension study to evaluate the effect of topiramate on abdominal visceral fat accumulation, a clinical surrogate known to be associated with the complications of obesity such as increased incidence of type 2 diabetes mellitus, hypertension, and dyslipidemia, and their associated morbidities. patients will be randomized to receive either daily topiramate or placebo. effectiveness will be measured by multiple parameters such as abdominal visceral fat (assessed by computed tomography), total and subcutaneous abdominal fat, body composition, body weight, body mass index, glucose tolerance, lipid profile, blood pressure, topiramate plasma concentration, or 24 hours energy expenditure (selected patients). safety evaluation (adverse events, vital signs, 12-lead ecg, clinical laboratory tests) will be conducted throughout the study. the study hypothesis is that topiramate is effective in reducing abdominal visceral fat in male patients and well tolerated. after the initial 12-week titration phase, patients will receive either topiramate (200mg twice daily or the maximum dose tolerated) or placebo by mouth for 6-months. then, patients will receive topiramate (200mg twice daily or the maximum tolerated dose) for 6-months during the open-label phase.

Eligibility criteria:
inclusion criteria: * bmi \>= 27 and =\< 40 * a waist circumference \>= 100 cm (39.4 inches) * baseline weight must be stable (varying no more than 4 kg (8.8 lbs)) for at least two months prior to enrollment * must be sedentary (less than one session of continuous moderate physical activity of 30 min/week) * must have blood lipid disorder * must be non-smokers exclusion criteria: * patients with endocrine disease or other physical causes of obesity * patients with significantly abnormal hepatic liver function tests or renal disease * history of schizophrenia, psychotic, or major affective disorder * history of epilepsy * history of eating disorders * history of any other significant medical conditions

Keywords: obesity abdominal obesity visceral fat subcutaneous fat dislipidemia hypertension type 2 diabetes mellitus
evaluation of the pneumrx lung volume reduction coil to treat emphysema

Conditions: Emphysema

Summary: the objective of this study is to demonstrate the safety of the pneumrx lung volume reduction coil (lvrc) in a population of patients with emphysema. the pneumrx, inc. lvrc is a used as a less invasive alternative to lung volume reduction surgery. the pneumrx lvrc is designed as an alternative to lung volume reduction surgery, potentially achieving the desired reduction in lung volume limiting the risks associated with major surgery, such as illness or death. this device is deployed through a bronchoscope and requires no incision.


Eligibility criteria:
inclusion criteria: * patient \> 35 years of age * unilateral or bilateral emphysema * patient has stopped smoking for a minimum of 8 weeks * read, understood and signed the informed consent form exclusion criteria: * patient has a history of recurrent clinically significant respiratory infection * patient has an inability to walk \>140 meters * patient has evidence of other disease that may compromise survival such as lung cancer, renal failure, etc * patient is pregnant or lactating * patient has clinically significant bronchiectasis * patient has had previous lvr surgery, lung transplant or lobectomy * patient has been involved in other pulmonary drug studies with 30 days prior to this study * patient has other disease that would interfere with completion of study, follow up assessments or that would adversely affect outcomes

Keywords: lvrs (lung volume reduction surgery) lvrc (lung volume reduction coil) emphysema coil repneu
china inherited ventricular arrhythmias registry

Conditions: Ventricular Arrythmia

Summary: this is an observational, prospective, multi-center registry, aiming at building a risk stratification for malignant inherited ventricular arrhythmias, including brugada syndrome(brs)、long qt syndrome(lqts)、short qt syndrome(sqts)、early repolarization syndrome(ers) and catecholaminergic polymorphic ventricular tachycardia(cpvt). 500 participants will be recruited from 10 centers in china, with clinical data to be abstracted from medical records, and blood samples to be collected for finding related genes and promising risk indicators. the follow-up should be made every 6 months.

in china, the prevalence and risk factors of malignant ventricular arrhythmias remain unclear. in addition, mainstream treatment relies on implantable devices and medication. china malignant ventricular arrhythmias study is a nation-wide complex consisting of several interrelated studies, with the aim of building a risk stratification as well as an efficient and economic strategy for early prevention and treatment. inherited ventricular arrhythmias registry, as a part of china malignant ventricular arrhythmias study, is an observational, prospective, multi-center registry, aiming at exploring the correlation between genotype and phenotype for inherited structural ventricular arrhythmias, thus helping molecular diagnosis and risk stratification of these conditions. 500 patients with definitive diagnosis will be recruited consecutively from 10 major arrhythmia centers distributed in 6 areas in china. at study entry, participants will be interviewed and asked to sign the informed consent. demographic characteristics, medical history, clinical features, laboratory tests, imaging pictures, medications, procedures, and in-hospital outcomes of patients will be abstracted from medical records by well-trained staffs. at the same time, blood samples will be collected to detect biological markers, like genes, inflammatory factors ,etc. once enrolled, the participants will receive follow up every 6 mouths about condition of arrhythmia, medication, clinical events, etc.

Eligibility criteria:
inclusion criteria: * diagnosed as brugada syndrome(brs)、long qt syndrome(lqts)、short qt syndrome(sqts)、early repolarization syndrome(ers) or catecholaminergic polymorphic ventricular tachycardia(cpvt). exclusion criteria: * patients were enrolled by other clinical trials.

Keywords: brugada syndrome long qt syndrome short qt syndrome early repolarization syndrome catecholaminergic polymorphic ventricular tachycardia
danheart (h-heft and met-heft)

Conditions: Heart Failure; Diabetes

Summary: the present study is testing in a combined design to types of drugs in patients with chronic heart failure: 1) hydralazine in combination with isosorbide dinitrate (bidil) and 2) metformin hydrochloride. the study is double blind, placebo controlled. 1. the first hypothesis is that hydralazine in combination with isosorbide dinitrate can reduce mortality and hospitalization with worsening heart failure in chronic heart failure patients with reduced lvef. 2. the second hypothesis is that treatment with metformin in chronic heart failure patients with reduced lvef and type 2 diabetes / diabetes risk / insulin resistance can reduce mortality and cardiovascular hospitalizations. among secondary endpoints are reduction in new-onset diabetes in heart failure patients with insulin resistance and diabetes risk profile and patient safety.


Eligibility criteria:
inclusion criteria: general inclusion criteria for both h-heft and met-heft * patients with chronic heart failure * nyha-class ii, iii or iv * lvef \ 110/min) and (iiii) the echocardiography should be performed at least 3 months after crt-implantation. * patients should be uptitrated to recommended or maximally tolerated dose of ace-i/arb/arni (unless contraindicated) and beta-blocker (unless contraindicated). if indicated, an aldosterone receptor antagonist should be given (unless contraindicated). * a crt device should be implanted, if indicated and accepted by the patient and patients with a crt device should be treated for \> 3 months. * implantation of an icd unit should be planned or already done, if indicated and accepted by the patient. the patient can be included in the study before a planned icd implantation has been performed. * informed consent specific inclusion criteria for only h-heft: * systolic blood pressure ≥100 mmhg * nt-probnp \> 350 pg/ml or bnp \> 80 pg/ml (in patients treated with arni, nt-probnp must be used) specific inclusion criteria for only met-heft: patients must have a diagnosis of type 2 diabetes or insulin resistance or diabetes risk. this includes 1 or more of any of the following: * a previous diagnosis of type 2 diabetes at any time without metformin treatment during the last 3 months * hba1c ≥ 5.5 % (≥ 37 mmol/mol) within 12 months prior to screening * fasting p-glucose ≥ 5.6 mmol/l within 12 months prior to screening (measured when the patient in stable condition / has no intercurrent illness) * body mass index ≥ 30 kg/m2 * if oral glucose tolerance testing (ogtt) has been performed at any time prior to randomization: 2 hour p-glucose ≥ 7.8 mmol/l * in addition, patients in met-heft must have egfr ≥ 35 ml/min (mdrd) patients are randomized through an internet based randomization module. patients can be allocated to a) both h-heft and met-heft or to b) only h-heft or to c) only met-heft.

Keywords: heart failure diabetes insulin resistance metformin hydralazine isosorbide dinitrate
salvage peanut oral immunotherapy study

Conditions: Peanut Allergy

Summary: the purpose of this trial is to study the safety of rescue peanut oral immunotherapy followed by the introduction of dietary peanut for patients with peanut allergy who have lost desensitization during a peanut immunotherapy trial.

salvage peanut oral immunotherapy study is a single-arm, open label trial of peanut flour oral immunotherapy (oit) administered for 6 months followed by introduction of dietary peanut for an additional 6 months. the peanut oit phase will involve approximately 3 months of dose escalation up to a maintenance dose of 300 mg peanut protein. this is followed by 3 months of daily maintenance dosing with 300 mg of peanut protein. patients are then transitioned to the dietary peanut phase ingesting common foods containing approximately 300 mg of peanut protein daily. safety will be assessed during both peanut oit and dietary peanut phases with adverse events recorded including gastrointestinal side effects. they will also be monitored for any anaphylaxis or injectable epinephrine administration. data regarding compliance with peanut oit will be collected as well.

Eligibility criteria:
inclusion criteria: * subjects who have completed an immunotherapy trial for peanut allergy within the last 6 months and are unable to tolerate ≥ 300mg of peanut. * age 1-65 years of either sex, any race, any ethnicity. written informed consent from patient or parent/guardian (if \< 18 years) with participant's assent. exclusion criteria: * current participation in an interventional study for peanut allergy * history of a severe anaphylactic reaction to peanut, defined as hypoxia, hypotension, or neurologic compromise (cyanosis or spo2 ≤ 92% at any stage, hypotension, confusion, collapse, loss of consciousness, or incontinence) * eosinophilic or other inflammatory (e.g. celiac) gastrointestinal disease * severe asthma (2007 nhlbi criteria steps 5 or 6 , appendix 2) * use of b blockers (oral), angiotensin-converting enzyme (ace) inhibitors, angiotensin-receptor blockers (arb) or calcium channel blockers * significant medical condition (e.g., liver, kidney, gastrointestinal, cardiovascular, hematologic, or pulmonary disease) which would put the subject at risk for induction of severe food reactions. pregnancy or lactation.

Keywords: peanut
cerebral vascular reserve in small vessel disease and alzheimers disease

Conditions: Alzheimer Disease; Dementia, Vascular

Summary: alzheimers disease and cerebral small vessel disease have a considerably overlap in patients and have common risk factors. the diseases are difficult to separate in individual patients and we hypothesize that a reduced cerebral vascular reserve may be a measurement of small vessel disease independent of alzheimers disease. patients with presumed alzheimers disease (n=20), cerebral small vessel disease (n=20) and healthy age-matched subjects (n=15) are examined with quantitative \[15o\]h2o positron emission tomography (pet) for measurements of brain perfusion before and after diamox infusion that dilates cerebral vessels. additional \[15o\]h2o pet scans of the heart allows for a non-invasive input function so the cerebral vascular reserve can be measured quantitatively.

alzheimers disease and cerebral small vessel disease are increasingly common in the elderly population and constitute around 90% of new dementia cases in denmark. the diseases have a considerably overlap in patients and have common risk factors. the cause of dementia can be difficult to separate in individual patients but a reduced cerebral vascular reserve may be a measurement of small vessel disease independent of alzheimers disease. we hypothesized that patient with small vessel disease have reduced increase in brain perfusion after medical brain vessel dilatation. while alzheimer patients may have reduced perfusion in rest but normal increase after medical brain vessel dilatation as compared to healthy subjects. patients with presumed alzheimers disease (n=20), cerebral small vessel disease (n=20) and healthy age-matched subjects (n=15) are examined with quantitative \[15o\]h2o pet for measurements of brain perfusion before and after diamox infusion that dilates cerebral vessels. additional \[15o\]h2o pet scans of the heart allows for a non-invasive input function so the cerebral vascular reserve can be measured quantitatively.

Eligibility criteria:
inclusion criteria: * presumed alzheimer's disease (group 1) * diagnosed with small vessel disease of the brain by mri and presumed cognitive dysfunction (group 2) exclusion criteria: * major claustrophobia * major psychiatric diseases * other major somatic diseases * allergy to diamox

Keywords: positron-emission tomography perfusion