Kornimate/medical-research-clean huggingface dataset:
evolocumab in patients with multivessel coronary disease after acute myocardial infarction: a target trial emulation

Conditions: Multivessel Coronary Artery Disease; Acute Myocardial Infarction (AMI)

Summary: the goal of this target trial emulation (tte) study is to evaluate the effect of evolocumab on clinical prognosis in patients with multivessel disease (mvd) following acute myocardial infarction (ami) who have deferred non-culprit vessel. the main question it aims to answer is: does evolocumab lower risks of major adverse cardiovascular events (mace) in patients with deferred non-culprit vessel after ami?

this study aims to investigate the potential prognostic benefits of evolocumab in patients with mvd after ami at 2-year follow-up. the primary endpoint is mace, defined as a composite of cardiac death, myocardial infarction, stroke, angina-driven coronary revascularization, and rehospitalization for heart failure. this is a multicentre, cohort-based tte study and the target rct is the fourier trial.

Eligibility criteria:
inclusion criteria: * age ≥18 years old; * acute myocardial infarction diagnosed at hospital admission; * multivessel coronary artery disease diagnosed at primary invasive coronary angiography; * culprit vessel successfully revascularized; * at lease 1 non-culprit vessel with ≥50% stenosis and deferred at the opinion of the operator, and no staged revascularization within 6 months. exclusion criteria: * cardiac shock, hemodynamically unstable, or severe heart failure (killip iv) * any cardiac surgery within 6 weeks prior to screening; * moderate to severe renal dysfunction, defined as an estimated glomerular filtration rate (egfr) less than 30 ml/min/1.73m\^2 at screening; * contraindication or allergy to iodinated contrast agent; * malignancy except non-melanoma skin cancers, cervical, or breast ductal carcinoma in situ within the last 5 years; * female subject is pregnant or breastfeeding or planning to become pregnant or breastfeed in short term.

Keywords: evelocumab non-culprit vessel multivessel coronary artery disease acute myocardial infarction outcome target trial emulation
a study to evaluate the efficacy, safety, and pharmacokinetics of uttr1147a compared with placebo and with vedolizumab in participants with moderate to severe ulcerative colitis (uc)

Conditions: Ulcerative Colitis

Summary: this study is designed to evaluate the efficacy, safety, and pharmacokinetics of uttr1147a compared with vedolizumab and with placebo in the treatment of participants with moderate to severe uc. this study will consist of two parts, part a and part b. part a will test the induction of clinical remission and part b will test the durability of clinical remission.


Eligibility criteria:
inclusion criteria: * diagnosis of uc * confirmation of moderately to severely active uc, defined by the mayo clinic score * inadequate response, loss of response, or intolerance to prior immunosuppressant treatment (i.e., azathioprine, 6-mercaptopurine, methotrexate, or tumor necrosis factor \[tnf\] inhibitors \[maximum of 2 prior tnf inhibitors\]) and/or corticosteroid treatment * use of highly effective contraception as defined by the protocol exclusion criteria: * history of psoriasis or psoriatic arthritis; any other inflammatory skin disorders requiring oral corticosteroids, immunosuppressants, or biological therapy within the previous year; or primary sclerosing cholangitis * history of cancer as defined by the protocol * significant uncontrolled comorbidity, such as cardiac, pulmonary, renal, hepatic, endocrine, or gastrointestinal disorders (excluding uc) * prior extensive colonic resection, subtotal or total colectomy, or proctocolectomy, or planned surgery for uc * diagnosis of indeterminate colitis or granulomatous (crohn's) colitis or toxic megacolon within 12 months prior to screening * suspicion of ischemic colitis, radiation colitis, or microscopic colitis * current fistula or history of fistula, pericolonic abscess and stricture (stenosis) of the colon * history or current evidence of unresectable colonic mucosal dysplasia or history of high-grade colonic mucosal dysplasia * prior treatment with uttr1147a * prior treatment with vedolizumab, etrolizumab, natalizumab, efalizumab, or any other anti-integrin agents * prior treatment with rituximab * use of prohibited therapies, as defined by the protocol, prior to randomization * congenital or acquired immune deficiency * evidence or treatment of infections or history of infections, as defined by the protocol
usage of spirometry in managing igg therapy in cvid with airway disease

Conditions: Common Variable Immunodeficiency

Summary: although there is evidence in the literature that gammaglobulin replacement therapy can lead to a reduction in the prevalence of pulmonary infection and improved lung function, there is no published study to guide immunologists regarding the use of spirometry in titrating ig therapy to assist in the management of immunodeficiency patients with regards to gammaglobulin replacement therapy. the investigators propose to study the use of spirometry to identify patients that could potentially benefit from an increase in igrt. the investigators will identify 22 common variable immune deficiency (cvid) study subjects on stable igrt replacement therapy equivalent to 0.40 to 0.60 gm/kg per 4 weeks who have evidence of mild to moderate obstruction as assessed by an fef25-75% between 50% and 80% of predicted. patients who are on hizentra will be preferentially recruited. of these 22, 11 will be identified at random and treated for 6 months at their current dose (control population). the remaining 11 study subjects (treatment group) will have their level of igrt increased by the equivalent of 0.05 gm/kg in dose per 4 weeks, adjusted for bioavailability as per manufacturer's instructions. on average, rounded up to the nearest gram, this will typically increase their dose of hizentra by 2 gm per week.

the key finding of the published retrospective study was that common variable immune deficiency (cvid) patients with moderate, presumed reversible, obstruction on stable, therapeutic doses of igg who exhibited a decline in lung function from one clinic visit to the next responded to an increased dose of igg with an improvement in lung function as assessed by spirometry. the investigators now wish perform a clinical trial to assess whether primary antibody deficiency patients receiving igrt who fit in this range of obstruction, i.e. an fef25-75% that is 50-80% of predicted, will demonstrate an increase in lung function, as assessed by spirometry, after increasing the dose of igrt. the presumption is that obstruction at this level is most likely due to the effects of subclinical infections that can be reduced or avoided by increasing the amount of gammaglobulin received by the patients.

Eligibility criteria:
inclusion criteria: 1. patients who meet criteria for common variable immune deficiency (cvid) who are on stable igrt for at least 3 months and who have an fef25-75% between 50% and 80% of predicted. 2. patients who are already on hizentra will be preferred. exclusion criteria: 1. age \<21 or cannot perform spirometry. 2. smokers with 20 pack years or more, and active smokers will not be included among the study subjects, but will be considered separately as an ancillary study. 3. patients with specific antigen-specific antibody deficiencies or x-linked agammaglobulinemia on igrt will not be included among the 20 study subjects, but will be considered separately in ancillary studies. 4. patients with heart failure, tb, bronchiolitis, or lymphangioleiomyomatosis.
specialized treatment early in psychosis (step)

Conditions: Schizophrenia and Disorders With Psychotic Features

Summary: the purpose of this study is to understand the effectiveness of a specialized package of phase-specific treatments for individuals in the midst of their first episode of psychosis. the pharmacologic and psychosocial treatments will be delivered within a state public mental health center.

we propose to conduct a clinical trial for first episode psychosis patients not eligible for cmhc services that will compare randomized access to care at cmhc versus the usual procedure of referral to community providers outside cmhc. patients randomized to access to cmhc services will receive multifaceted, intensive, phase-specific care delivered by a specialized clinical team. this care will include five principal components: antipsychotic prescription, multi-family group therapy, group cognitive behavioral therapy, cognitive remediation and individual case management including supportive, problem solving approaches and a focus on resumption of movement towards educational and/or employment related goals. all consenting subjects will undergo research evaluations every six months for up to five years. outcomes will be assessed in the domains of re-admission (primary outcome), relapse, symptoms, overall functioning, quality of life, education and employment, treatment satisfaction, adherence, substance use, adverse events (including self-harm) and economic measures including service use, cost of care and forensic data.

Eligibility criteria:
inclusion criteria: 1. age 16-45 2. meets dsm-iv schizophrenia spectrum psychosis or affective psychosis according to the scid 3. ≤8 weeks of received antipsychotic treatment lifetime at time of referral 4. willing to be treated in new haven exclusion criteria: 1. psychosis believed due to substance use (based on the scid) 2. unable or unwilling to give informed consent 3. mr as indicated by receipt of services from dept of mental retardation

Keywords: first episode psychosis specialized care phase-specific treatment schizophrenia disorders with psychotic features
oral nutrition supplementation in hospitalized patients

Conditions: Malnutrition

Summary: the purpose of this pilot study is to determine the effect of 3 months use of enhanced oral nutritional supplement (ons) on physical function and functional performance in malnourished elderly patients.

the purpose of this pilot study is to determine the effect of 3 months use of enhanced oral nutritional supplementation (ons) on muscle accretion and functional performance in malnourished elderly patients. the objectives of this study are to determine feasibility of recruitment, adherence to intervention and retention of the sample, as well as the capacity of subjects to complete functional and muscle mass measures for a planned multi-centre randomized controlled trial (rct).

Eligibility criteria:
inclusion criteria: * admitted to a general medical ward and recruited within 48 hours * over the age of 65 years * malnourished (subjective global assessment categories b or c patients) exclusion criteria: * have an allergy or intolerance to any component of the oral supplement * are designated palliative care * are currently suffering from refeeding syndrome * have a pre-existing medical condition that prevents oral intake of full fluids, * have an expected length of stay of less than 48 hours from the time of assessment * have suspected ischemic stroke as cause for admission * reside in a residential care home * are unable to walk prior to current illness. * are pregnant/breastfeeding * have a current diagnosis of diabetic ketoacidosis or hyperglycemic hyperosmolar syndrome

Keywords: oral nutrition supplementation
study of lenacapavir for hiv pre-exposure prophylaxis in people who are at risk for hiv infection

Conditions: Pre-Exposure Prophylaxis of HIV Infection

Summary: the goal of this clinical study is to test how well the study drug, lenacapavir (len), works in preventing the risk of hiv.


Eligibility criteria:
key inclusion criteria: incidence phase * cgm, tgw, tgm, and gnb who have condomless receptive anal sex with partners assigned male at birth and are at risk for hiv infection. * hiv-1 status unknown at screening and no prior hiv-1 testing within the last 3 months. * sexually active with ≥ 1 partner assigned male at birth (condomless receptive anal sex) in the last 12 months and 1 of the following: * condomless receptive anal sex with ≥ 2 partners in the last 12 weeks. * history of syphilis, rectal gonorrhea, or rectal chlamydia in the last 24 weeks. * self-reported use of stimulants with sex in the last 12 weeks. randomized phase * negative local rapid fourth generation hiv-1/2 ab/ag, central fourth generation hiv-1/2 ab/ag, and hiv-1 rna quantitative nucleic acid amplification testing (naat). * estimated glomerular filtration rate (egfr) ≥ 60 ml/min at screening according to the cockcroft-gault formula for creatinine clearance (clcr). key exclusion criteria: incidence phase * prior use of hiv prep (including f/tdf or f/taf) or hiv postexposure prophylaxis (pep) in the past 12 weeks or any prior use of long-acting systemic prep (including cabotegravir or islatravir). * prior recipient of an hiv vaccine or hiv broadly neutralizing antibody formulation. randomized phase * acute viral hepatitis a, b or c or evidence of chronic hepatitis b or c infection. * severe hepatic impairment or a history of or current clinical decompensated liver cirrhosis. note: other protocol defined inclusion/exclusion criteria may apply.
quantitation of left ventricular ejection fraction change from early exercise gated stress/rest tc-99m czt-spect mpi

Conditions: Coronary Artery Disease

Summary: the aim of this study is to evaluate early post-stress ef change (∆ef) and its relation to the severity of myocardial ischemia and angiographic coronary disease using czt-spect mpi.

single photon emission computed tomography (spect) myocardial perfusion imaging (mpi) is a well-established noninvasive procedure for the evaluation and risk stratification of patients with coronary artery disease (cad). however, it has been recognized that in certain patients spect mpi is unable to detect the presence of cad or underestimates its extent. the fact that moderate to severe perfusion defects are noted in less than half of the patients with significant left main disease has stimulated studies to improve the diagnostic accuracy of spect mpi. these studies have analyzed post-stress parameters such as left ventricular (lv) ejection fraction (ef), wall motion abnormalities and transient lv dilation. however, these parameters were derived from data acquired using conventional anger cameras as long as 60 minutes after stress tracer injection. such delayed assessment may miss early ischemic stunning as a result of its rapid transient changes. however, with highly sensitive detectors and short lived tracers, the ability of pet mpi to measure ef during peak of stress has been reported. similarly, the novel cadmium-zinc-telluride (czt) spect cameras with solid state cardiac-focused detectors are significantly more sensitive than the conventional anger scintillation cameras giving to spect the "pet-like" ability to image rapidly right after the stress test. the aim of this study is to evaluate early post-stress ef change (∆ef) and its relation to the severity of myocardial ischemia and angiographic coronary disease using czt-spect mpi.

Eligibility criteria:
inclusion criteria: the patients who will be able to complete exercise treadmill testing will be enrolled and analyzed. - exclusion criteria: * severe aortic stenosis * resting heart rate \> 130 beats/min * significant atrial or ventricular arrhythmia * sepsis * fever * hemodialysis * pregnancy
effects of lomitapide on carotid and aortic atherosclerosis

Conditions: Homozygous Familial Hypercholesterolemia

Summary: study to assess changes in carotid and aortic atherosclerosis in patients being treated with lomitapide.

this is a multi-center long-term open-label non-comparative study to assess changes in carotid and aortic atherosclerosis in patients being treated with lomitapide. patients from countries in the eu, the us and canada who are being treated with lomitapide and are enrolled in the lomitapide observational worldwide evaluation registry (lower), will be invited by the lower enrolling physician to participate in this substudy.

Eligibility criteria:
inclusion criteria: • adult patients (age ≥18 years) who are enrolled in lower exclusion criteria: * patients with a prior history of carotid angioplasty, carotid stenting, or carotid atherectomy * patients with a contraindication to mri examination (i.e., brain aneurysm, implanted neural stimulator, implanted cardiac pacemaker, pacemaker wires or defibrillator, prosthetic heart valves, cochlear implant, ocular foreign body, or other implanted body) * patients who have undergone a coronary stenting procedure in the preceding three weeks prior to enrollment * patients prone to claustrophobia or known anxiety disorders that will interfere with the ability to acquire quality mri scans * patients with an implanted insulin pump * patients with metal shrapnel or bullet wounds * patients with a body mass index (bmi) \> 40 kg/m2 (since it may be difficult to position comfortably with the mri scanner) * patients who work with metal lathes (unless an orbit x-ray performed prior to the enrollment mri scan has been done to rule out metal fragments in the eye)
neuromuscular electroestimulation and respiratory muscle training in subacute stroke

Conditions: Dysphagia

Summary: this study, part of a larger research project (the retornus study), is aimed to evaluate new strategies to optimize rehabilitation outcomes in dysphagic stroke patients. main objective is to assess effectiveness of neuromuscular electroestimulation (nmes) in combination with respiratory muscle training (rmt) in the treatment of oropharyngeal dysphagia in subacute stroke patients.

dysphagia is present in a significant proportion of subacute stroke patients (up to 85%, depending on the series) and is associated with an increase in medical complications such as bronchoaspirative pneumoniae which is responsible for approximately half of the deaths that occur in these patients. besides, the risk of pneumonia in patients with dysphagia is three times higher compared to those patients without. since there is no drug able to restore the swallowing and respiratory muscle function, neurological rehabilitation apperars to be as the mainstay of treatment of these disorders. respiratory muscle weakness is common after stroke, but how it contributes in the development of bronchoaspiration pneumonia is not well determined. in acute phases of stroke, the mechanism seems to be more related to an impaired central drive than the reduction of strength in respiratory muscle. otherwise, the nmes aims to improve muscle strength. the nmes accelerates swallowing recovery since it induces brain reorganitzation after stroke through sensory and motor stimulation of peripheral nerves, mainly in swallowing aerea.

Eligibility criteria:
inclusion criteria: * first-ever ischemic stroke * time since stroke onset: 1 to 3 weeks * tracheobronchial aspiration evaluated with the gold standard, videofluoroscopy, * cognitive impairment (short portable mental status questionnaire less than 3) exclusion criteria: * previous history of neurological diseases that might be associated with the presence of dysphagia * previous history of pulmonary diseases * significant alcohol abuse (\>80 g/day) and 4) medical treatment with potential effect on muscle structure and function (steroids,thyroid hormones, immunosuppressors).

Keywords: respiratory muscle training neuromuscular electrical stimulation oropharyngeal dysphagia stroke rehabilitation
pharmacological treatment of presbyopia

Conditions: Near Vision

Summary: in this clinical trial, a total of 75 presbyopic patients in the age range of 40 to 60 years old will be participated. the right eyes of 45 patients will be treated by biocarpine® and they will be considered as the case group, their left eyes will be defined as the controls. in another case group, the right eyes of 30 patients will received vuity® eye drops and their left eyes will be considered as controls.


Eligibility criteria:
inclusion criteria: * subjects with the best corrected visual acuity (bcva) better than 0.3logmar * patients with the symptom of blurred vision at near distance exclusion criteria: patients with amblyopia, cataract, corneal opacity, glaucoma, intraocular surgery, eye troma, congenital pupil anomalies and those with the history of headache and allergy to the eye drop will be excluded from the study.
study on obesity intervention with physical exercise among students in changping district, beijing

Conditions: Pediatric Obesity

Summary: the primary objective of this study is to assess the effectiveness of a school based physical activity programme on obesity and related health outcomes in young schoolchildren.


Eligibility criteria:
inclusion criteria: * grade of 2 to 5 in elementary schools and grade of 1 to 2 in middle schools. exclusion criteria: * suffering or any history of disabilities, cardiovascular diseases, asthma, metabolic diseases, etc.

Keywords: obesity physical activity schoolchildren intervention studies
evaluation of cl detect™ rapid test to detect cutaneous leishmaniasis

Conditions: Skin Diseases

Summary: this study is a single-site trial assessing the specificity of cl detect™ rapid test versus the gold standard for leishmania diagnosis in the us which is microscopic identification of leishmania amastigotes in a stained lesion sample. subjects will be patients who present for dermatology consultation with a primarily ulcerated lesion. after informed consent is obtained and the subject is screened for eligibility, 2 diagnostic samples will be collected from the subject's lesion in the following order: 1) one sample will be obtained with a dental broach for use with the cl detect™ rapid test and 2) a second sample will be obtained by scraping for use in the microscopic identification of amastigotes. samples will be analyzed by microscopy and cl detect™ rapid test. the cl detect™ rapid test will be performed by different operators who are clinical staff members. these staff members, blinded to each other's results, will evaluate the samples from each method independently. each of the 150 study subjects will be followed administratively to the point where a diagnosis is established (if possible) for their tested lesion, even if that diagnosis is not cutaneous leishmaniasis (cl). if a specific diagnosis cannot be determined for a non-cl lesion, the investigator will assign a "likely etiology" (eg, infectious, oncological, immunological, vascular, or "undetermined/other" origin). based on the diagnosis determined for each lesion, subjects will be referred for appropriate treatment.


Eligibility criteria:
inclusion criteria: * at least 18 years of age * subject is able to give written informed consent * subject has a skin ulcer that satisfies the following criteria for an index lesion: * less than 4 months in age * primarily ulcerative, not purely verrucous or nodular, and does not have clear clinical evidence of cellulitis * in a location suitable for collecting samples by dental broach and scraping * in the opinion of the investigator, the subject is capable of understanding and complying with the protocol exclusion criteria: * received treatment for leishmaniasis or any treatment to the lesion even if not previously diagnosed as leishmaniasis such as azoles, cryotherapy, imiquimod, thermotherapy, photodynamic therapy, within 2 months prior to signing the consent form, with the exception of mercurochrome