Kornimate/medical-research-clean huggingface dataset:
comparison of the effect of vytorin 10/80 tablet split into 4 and simvastatin 20 milligrams on low-density lipoprotein (ldl) cholesterol

Conditions: Hypercholesterolemia

Summary: the purpose of this study is to compare the efficacy of a vytorin 10/80 tablet, an approved agent for the treatment of elevated ldl cholesterol which combines the cholesterol absorption inhibitor ezetimibe 10 mg and simvastatin 80 mg, when split into 4 using a tablet splitter, versus a whole simvastatin 20 milligram tablet.


Eligibility criteria:
inclusion criteria: * subjects with an ldl-cholesterol greater than 100 mg/dl * patients willing and able to provide signed informed consent exclusion criteria: * patients receiving a statin (lipitor, crestor, lescol, simvastatin, or pravachol) * patients intolerant of statins * patients receiving ezetimibe * patients intolerant of ezetimibe * patients receiving a niacin preparation * stroke, tia, myocardial infarction, unstable angina, percutaneous coronary intervention, coronary artery bypass surgery, or major surgery within 3 months * cancer undergoing active treatment * creatinine clearance \< 50 ml/minute * active liver disease or persistent elevation of sgot or sgpt \> 2 times the upper limit of normal level * participation in any clinical study within the last 30 days * drug addition or alcohol abuse within the past 6 months * use of azole antifungal agents, amiodarone, fibrates or immunosuppressant drugs within the last 3 months * active use of macrolide antibiotics or verapamil * consumption of grapefruit juice on a daily basis * patients unwilling or unable to provide informed consent * patients with poor compliance * women of childbearing potential

Keywords: hypercholesterolemia statins ezetimibe
multicenter retrospective study of isoflurane in refractory and super-refractory status epilepticus

Conditions: Refractory Status Epilepticus

Summary: isoflurane might be used as anticonvulsive therapy in refractory status epilepticus. the aim of the study is to assess the efficiency of isoflurane in this indication.

investigators will collect in 4 icus the data from consecutive patients hospitalized between january 2016 and january 2023. included patient were those treated by isoflurane for refractory status epilepticus.

Eligibility criteria:
inclusion criteria: * age \> 18 years, hospitalized in icu between 2016-01-01 and 2023-01-01, suffering refractory status epilepticus treated by inhaled isoflurane as third anticonvulsive therapy exclusion criteria: * post-anoxic refractory status epilepticus after cardiac arrest, withdrawal of consent for medical data use

Keywords: isoflurane
study of aro-c3 in adult healthy volunteers and patients with complement mediated renal disease

Conditions: C3 Glomerulopathy; IgA Nephropathy

Summary: the purpose of aroc3-1001 is to evaluate the safety, tolerability, pharmacokinetics and/or pharmacodynamics in adult healthy volunteers (hvs) and in adult patients with complement-mediated renal disease (c3 glomerulopathy \[c3g\] and iga nephropathy \[igan\]). in part 1 of the study, hvs will receive either one or two doses of aro-c3 or placebo. in part 2 of the study, adult patients with c3g/igan will receive 3 open-label doses of aro-c3. dose levels in part 2 will be determined based on cumulative safety and pharmacodynamic data from part 1.


Eligibility criteria:
inclusion criteria (all participants): * willing to provide written informed consent and to comply with study requirements * female participants must be non-pregnant/non-lactating * healthy volunteers must be willing to be vaccinated with a meningococcal and pneumococcal vaccine. c3g and igan participants must have been vaccinated or willing to undergo vaccination * all participants must be willing to be vaccinated or have a history of vaccination for haemophilus influenzae * body mass index (bmi) between 18.0 and 35.0 kg/m2 * 12-lead electrocardiogram (ecg) at screening with no abnormalities that may compromise participant's safety at discretion of investigator * participants of childbearing potential must use highly effective contraception during the study and for at least 12 weeks following the end of the study or last dose of study drug, whichever is later. males must not donate sperm during the study and for at least 12 weeks following the end of the study or last dose of study drug, whichever is later. * no abnormal finding of clinical relevance at the screening evaluation that, in the opinion of the investigator, could adversely impact participant safety or study results inclusion criteria (c3g and igan participants): * diagnosis of c3g or igan * clinical evidence of ongoing disease based on significant proteinuria * estimated glomerular filtration rate ≥30 ml/min/1.73 m2 at screening and currently not on dialysis * must be on a maximally recommended or tolerated dose of an angiotensin converting enzyme inhibitor (acei) or angiotensin receptor blocker (arb) exclusion criteria (all participants): * seropositive for human immunodeficiency virus (hiv) infection,hepatitis b virus, or hepatitis c virus * history of recurrent or chronic infections * uncontrolled hypertension * regular use of alcohol within 30 days prior to screening * use of illicit drugs within 1 year prior to screening or positive urine drug screen at screening * history of meningococcal infection * history of asplenia or splenectomy * known contraindication or history of anaphylactic reaction to any vaccine or vaccine component or prophylactic antibiotics planned for use in the study * any medical or surgical condition that, in the opinion of the investigator, would expose the participant to a significant safety risk or compromise the results of the study note: additional inclusion/exclusion criteria may apply per protocol
train-bw: backward walking training in multiple sclerosis

Conditions: Multiple Sclerosis; Gait Disorders, Neurologic; Accidental Fall

Summary: individuals with multiple sclerosis (ms) experience in impairments in mobility and cognition that increase the risk for accidental falls. more than 50% of individuals with ms experience injurious falls within a 6-month period. current interventions to improve fall risk have focused on forward walking (fw) and balance training, resulting in small declines in the relative risk for falls with a large degree of variability. interestingly, motor differences between ms and healthy controls are more pronounced in backward walking (bw), yet no studies have investigated bw training as an intervention to reduce fall risk in persons with ms. this study will investigate the feasibility, acceptability and impact of bw training compared to forward walking training on motor function and fall risk in persons with ms.


Eligibility criteria:
inclusion criteria: * diagnosis of ms * pdds \ /= 50% of the time * self-reported walking dysfunction as evidenced by a score of \>/= 30 on msws-12 or reports of 2 or more falls in the prior 6 months, indicating a frequent faller. exclusion criteria: * ms relapse within the past 30 days * comorbid neurological disorder * acute orthopedic disorder/injury * unable to follow study-related commands

Keywords: backward walking neurorehabilitation
safety and efficacy of nitrogen mustard in treatment of mycosis fungoides

Conditions: Mycosis Fungoides

Summary: this study will evaluate the efficacy, tolerability and safety of the topical application of mechlorethamine (mch) formulations in patients with stage i or iia mycosis fungoides (mf).

the successful use of mechlorethamine (mch) as a topical agent in the treatment of mycosis fungoides, a form of cutaneous t-cell lymphoma, was first reported in the late 1950s, and provided a rationale for skin-directed chemotherapy that minimized systemic toxicity. since then, multiple investigators have demonstrated the safety and efficacy of topically applied mch in the treatment of mycosis fungoides. this study will evaluate the efficacy (non-inferiority), tolerability and safety of topical application of mch proprietary gel versus a compounded ointment formulation in aquaphor in patients with stage i or iia mf.

Eligibility criteria:
inclusion criteria: * patients with mycosis fungoides confirmed by a skin biopsy * stage i or iia patients must have been treated previously with prior topical therapies including puva, uvb, topical steroids, but not nm within the past 2 years, or topical carmustine (bcnu) * patients must be otherwise healthy with acceptable organ function. * prior to initiating study therapy, patients must not have had topical therapy within four weeks * lab values within normal range * willing/able to give consent * must use effective means of contraception if of childbearing potential exclusion criteria: * newly diagnosed mycosis fungoides with no prior therapy * a prior history of treatment with topical nm within the past 2 years or topical carmustine (bcnu) * use of topical or systemic therapies for mf within four (4) weeks of entry in the study * patients with a diagnosis of stage iib-iv mf * serious known concurrent medical illness or infection, which could potentially present a safety risk and/or prevent compliance with the requirements of the treatment program * pregnant or nursing females, or males and females of childbearing potential, not using an effective means of contraception * patients who have had radiation therapy within one year of study start * patients who have a history of a higher t score than t2 or a higher n score than n1 * patients who do not agree to do all labs at one site

Keywords: mycosis fungoides nitrogen mustard cutaneous t-cell lymphoma ctcl - mycosis fungoides
integrating cognitive assessments into the heat tolerance test after exertional heat injury

Conditions: Exertional Heat Injury

Summary: this prospective observational study is to evaluate soldiers post-exertional heat injury (ehi) during a heat tolerant test (htt) to investigate the impact on their cognitive performance.

the objective of the proposed research is to add a cognitive evaluation to the physiological parameters monitored in the heat tolerance test (htt) and to construct a new cognitive-physiological model for evaluation based on the accumulated knowledge on soldiers' heat tolerance. each year, in the israel defense forces (idf), approximately 50 soldiers post exertional heat injury (ehi) are referred to perform the htt. the htt is carried out approximately one month post injury as part of clinical evaluation of the patient and is also intended to determine return to duty for combatants in field units. currently, the criteria used in the htt to determine heat tolerance are based solely on physiological parameters, while no cognitive evaluation is utilized in the htt. noteworthy are the numerous studies published in scientific literature describing the influence of exposure to heat conditions and physical effort on cognition and psychological strain in humans. the subjects performing the htt will also undergo cognitive evaluation and psychological strain assessment using tests used and validated in the research laboratories of the united states military (usariem). the cognitive evaluation will be performed in addition to the validated physiological monitoring performed in the htt. all gathered physiological and cognitive data will be used to construct new bio-statistical models and new criteria will be suggested for the definition of heat tolerance or intolerance.

Eligibility criteria:
inclusion criteria: * combat soldiers post exertional heat injury exclusion criteria: * additional medical condition restricting combat duty

Keywords: heat tolerance test exertional heat injury cognitive impairment thermoregulatory function
bay59-7939, japanese phase ii in atrial fibrillationtrial status

Conditions: Atrial Fibrillation

Summary: this is a clinical study investigating pharmacokinetics, pharmacodynamic effects and safety of bay 59-7939 in patients with atrial fibrillation (originally described in japanese).


Eligibility criteria:
inclusion criteria: * 20 years or older * japanese male or female * non- valvular atrial fibrillation documented by ecg * patients aged 60 years and older or with a risk of stroke exclusion criteria: * prior stroke and tia * patients in whom anticoagulants are contraindicated

Keywords: atrial fibrillation
evaluation of the metabolic effects of lcz696 and amlodipine in obese hypertensive subjects

Conditions: Hypertension; Concurrent Obesity

Summary: this study investigated the effects of lcz696 on insulin sensitivity, lipolysis, and oxidative metabolism in obese hypertensive subjects.


Eligibility criteria:
inclusion criteria: * written informed consent must be obtained before any study assessment is performed. * males and females of non-childbearing potential ≥ 18 years of age. * subjects with mild to moderate essential hypertension, * untreated subjects must have a mean seated sbp (mssbp) ≥ 130 mmhg and \< 180 mmhg at screening. * pre-treated subjects must have a mssbp ≤ 160 mmhg at screening and \< 180 mmhg at the end of the washout period. * waist circumference ≥ 102 cm (men) and ≥ 88 cm (women); exclusion criteria: * use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer; or longer if required by local regulations. * history of angioedema, drug-related or otherwise * history of hypersensitivity to lcz696, amlodipine, or drugs of similar chemical classes. * severe hypertension (grade 3 of who classification; msdbp ≥100 mmhg and/or mssbp ≥ 180 mmhg) at screening or at the end of the washout period. * type 1 or type 2 diabetes mellitus. * dyslipidemia requiring pharmacological therapy with a fibrate or nicotinic acid. * concomitant use of anti-hypertensives, anti-diabetics, or drugs with effects on glucose or lipid metabolism for the duration of the study. other protocol defined inclusion/exclusion criteria may apply

Keywords: hypertension, obesity, insulin sensitivity, lipolysis, lcz696
fall prevention program for non-ambulatory wheeled mobility device users living with ms

Conditions: Multiple Sclerosis

Summary: a research study to examine the effectiveness of a fall management program to prevent falls and develop fall recovery strategies for wheeled mobility device users living with multiple sclerosis.

falls are a serious concern for wheelchair and scooter users with multiple sclerosis (ms). approximately 75% of the population reports at least one fall in a 6-month period and nearly half report frequent falls. falls can result in physical injuries and contribute to activity curtailment. despite the negative consequences, limited evidenced-based fall prevention programs designed specifically for wheelchair and scooter users with ms exist. recognizing the threat falls pose to health and well-being and the dearth of fall prevention programs, the purpose of this study to perform a structured process evaluation and examine the feasibility and efficacy of a community-based intervention specifically designed to reduce fall incidence among wheelchair and scooter users with ms. secondary aims of the intervention are to improve functional mobility skills associated with fall risk (e.g. transfer and wheelchair skills, balance), increase knowledge of fall risk factors, decrease fear of falling and enhance quality of life and community participation.

Eligibility criteria:
inclusion criteria: 1. diagnosis of multiple sclerosis 2. \>18 years old 3. main form of mobility is via a wheeled mobility device (patient determined disease steps level 7) 4. self reported ability to transfer with moderate assistance or less 5. self-reported fall history (at least 1 fall/12 months) exclusion criteria: 1. ms exacerbation in the past 30 days 2. received a score of 10 or above to the short blessed test (attached) 3. inability to sit upright for at least 1 hour.

Keywords: wheelchair non-ambulatory
registry of patients with chronic thromboembolic pulmonary hypertension in novosibirsk region

Conditions: Chronic Thromboembolic Pulmonary Hypertension

Summary: there will be assessment of patients after acute pulmonary embolism for the development of cteph

there will be assessment of patients after acute pulmonary embolism for the development of cteph. there will be analysis of case histories of 40 patients with acute pulmonary embolism. all this patients will be clinically assessed by local cardiologist. also echocardiography, lung vq scans (perfusion and ventilation) will be performed. patients with chronic thromboembolic pulmonary hypertension will be assessed by local team experienced in cteph treatment.

Eligibility criteria:
inclusion criteria: * patients who had episodes of acute pulmonary embolism * 3-4 months of anticoagulation treatment after acute pulmonary embolism * informed consent exclusion criteria: * pregnancy
attention control training for the prevention of ptsd in firefighters

Conditions: PTSD

Summary: the study aimed to examine the effect of attention control training (act) intervention on reducing ptsd symptoms in firefighters. the study was a randomized controlled trial carried out in kunming, china, and involved the recruitment of 180 active firefighters as participants. the intervention lasted for an 8-week duration, during which participants participated in act exercises delivered through a smartphone application.


Eligibility criteria:
inclusion criteria: * being an active firefighter and aged between 18 and 50 * with no history of severe ptsd exclusion criteria: * having suicidal ideation or intent * having an active psychotic disorder other than ptsd * prior participation in a cognitive-behavioral intervention * concurrent participation in another study.

Keywords: ptsd attention control training
underwater versus conventional endoscopic mucosal resection in the treatment of non-pedunculated colorectal polyps

Conditions: Colorectal Polyp; Colorectal Neoplasms

Summary: a prospective, randomized, controlled study to compare the efficacy and safety of underwater endoscopic mucosal resection and conventional endoscopic mucosal resection in removal of non-pedunculated colorectal polyps

* patients are undergone colonoscopy at the endoscopy department of ho chi minh city university medical center. * randomize patients with non-pedunculated polyp of 10mm or larger in size into 2 interventional groups based on random function of statistical package for the social sciences (spss) 20.0, including (1) group 1: underwater endoscopic mucosal resection (uemr) and (2) group 2: conventional endoscopic mucosal resection (cemr). * the time of local recurrence assessment depends on the histopathology of polyps. polyps with low grade dysplasia are followed up at 6 months, while polyps with high grade dysplasia are followed at 3 months. * collecting variables which consist of primary and secodary outcomes.

Eligibility criteria:
inclusion criteria: * age \> 18 years * non-pedunculated polyps of 10 mm or more in size * type 1 or 2 according to nbi international colorectal endoscopy (nice) classification * patients must sign an informed consent form prior to registration in study exclusion criteria: * lesions with signs of deep invasion (hard, friable tissue, poor mobility, positive "non-lifting" sign) * type 3 according to nice classification * colorectal cancer * patients with unstable chronic disease (melitus diabetes, hypertension, heart failure, kidney failure, liver failure, chronic obstructive pulmonary disease) * hemostasis disorder (inr \> 1.5; platelets \< 100000/mm3)

Keywords: colorectal polyp underwater endoscopic mucosal resection conventional endoscopic mucosal resection
hormonal and metabolic effects of weight loss

Conditions: Obesity

Summary: the investigators here propose to evaluate the hormonal and metabolic effects of weight loss, including evaluation of changes in several tissues.


Eligibility criteria:
inclusion criteria: * bmi \> 27 kg/m2 (adults) exclusion criteria: * pregnancy, breastfeeding * patients with: * heart failure * impaired hepatic or renal function * anaemia * disturbed coagulation * infection, malabsorption * severe hypertension * any other endocrine disorder
a study for treatment of paroxysmal atrial fibrillation (paf) by pulsed field ablation (pfa) system with irreversible electroporation (ire)

Conditions: Atrial Fibrillation

Summary: the primary objective is to demonstrate safety and long-term effectiveness of the irreversible electroporation (ire) system (circular ire catheter and ire generator) when used for isolation of the atrial pulmonary veins (pvs) in treatment of participants with paroxysmal atrial fibrillation (paf).


Eligibility criteria:
inclusion criteria: * diagnosed with symptomatic paroxysmal atrial fibrillation (paf) * selected for atrial fibrillation (af) ablation procedure by pulmonary vein isolation (pvi) * failed at least one antiarrhythmic drug (aad) (class i to iv) as evidenced by recurrent symptomatic atrial fibrillation af, or intolerable or contraindicated to the aad * willing and capable of providing consent * able and willing to comply with all pre-, post- and follow-up testing and requirements exclusion criteria: * af secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause * previous left atrium (la) ablation or surgery * participant known to require ablation outside the pv region (example. cavotricuspid isthmus \[cti\] region, atrioventricular reentrant tachycardia, atrioventricular nodal reentry tachycardia, atrial tachycardia, ventricular tachycardia and wolff-parkinson-white) * previously diagnosed with persistent af (greater than \[\>\] 7 days in duration) * severe dilatation of the la (lad \>50 millimeter (mm) antero-posterior diameter in case of transthoracic echocardiography (tte))