Kornimate/medical-research-clean huggingface dataset:
pilot study to compare fresh frozen plasma with 24-hour plasma in babies up to age six months

Conditions: Blood Coagulation Disorders

Summary: with the advent of measures to try to decrease the incidence of transfusion-related acute lung injury (trali), the blood bank industry is attempting to avoid collection of plasma from female donors who have been pregnant in order to reduce the transfusion of plasma that may contain hla antibodies. this has led to a decrease in the number of donors available for the production of fresh frozen plasma (ffp). per blood bank regulatory standards in the united states, ffp must be frozen within 8 hours of collection. plasma that is frozen within 24 hours of collection is called fp24, and it is produced when whole blood cannot be processed within the 8-hour time period for the generation of ffp. studies of coagulation factors in ffp and fp24 have shown that coagulation factor activities are adequate to maintain hemostasis in both products. many hospitals are using ffp and fp24 interchangeably in adults, and occasional hospitals are using these products interchangeably in neonates. however, studies concerning the use of fp24 in neonates have not been performed. the investigators propose a single center prospective pilot study comparing the clinical efficacy of ffp vs. fp24 in 50 nonsurgical neonates and babies up to age 6 months requiring plasma for an international normalization ratio (inr) of 1.5 or more. this protocol describes a pilot study to compare the use of ffp with fp24 in nonsurgical neonates. use of plasma in these cases is mostly for patients with perinatal hypoxia or necrotizing enterocolitis and an inr of 1.5 or more. transfusion of plasma (10 to 15 ml/kg) is performed for these patients approximately every 8, 12, or 24 hours, as deemed indicated by the patient's clinicians, and monitored with prothrombin time (pt), partial thromboplastin time (ptt), and inr.

half the patients will be randomized by the blood bank to receive ffp, the other half fp24. all patients will be monitored in the usual way, with careful clinical observation and with pt/ptt/inr, to be drawn once in 12 or 24 hours based on clinical necessity. if a patient needs additional transfusions, the same type of product will be administered for each episode.

Eligibility criteria:
inclusion criteria: * nonsurgical neonates and babies up to age 6 months with inr 1.5 or more who are deemed clinically to need plasma infusion. exclusion criteria: * patients who are being prepared for surgery, or during or after surgery. * patients with congenital anomalies, chromosomal anomalies, or heart defects. * patients whose parents refuse to consent.
results of tc99m-maraciclatide scintigraphy in subjects with diabetes mellitus and heart failure with preserved left ventricular ejection fraction

Conditions: Diabetes Mellitus; Heart Failure

Summary: the purpose of this study is to evaluate the results of 99mtc maraciclatide scintigraphy in diabetic subjects with hfpef. a maximum of 20 subjects with diabetes mellitus (dm) and heart failure with preserved left ventricular ejection fraction (hfpef) will be enrolled and imaged with 99mtc maraciclatide. in addition, a maximum of 10 subjects with dm and diastolic dysfunction but no diagnosis of heart failure (hf) will be enrolled and imaged with 99mtc-maraciclatide.


Eligibility criteria:
inclusion criteria: * the subject is between 18 and 80 years of age. * the subject was diagnosed with dm type 2 based upon accepted clinical criteria and currently takes at least one diabetes medication. * for hf subjects: the subject was diagnosed with hf with preserved ef within the previous 1 year, at which time lvef was determined to be ≥45%. * for comparison subjects: the subject was determined to have diastolic dysfunction on ekg within the previous year and currently has no signs or symptoms of hf. * the subject has been clinically stable for at least 7 days prior to the study imaging procedures (e.g., not experiencing continuing chest pain, hemodynamic instability, worsening hf symptoms, or clinically significant arrhythmia). exclusion criteria: * the subject had an acute myocardial infarction within the past 30 days. * the subject had a cardiac revascularization (e.g., percutaneous transluminal coronary angiography \[ptca\], percutaneous coronary intervention (pci), or coronary artery bypass graft \[cabg\]) within the past 30 days. * the subject has severe renal dysfunction. * the subject is claustrophobic or has a movement disorder that prevents him/her from lying still in a supine position for up to 20 minutes at a time. * the subject has participated in a research study using ionizing radiation in the previous 12 months.

Keywords: ce-mri - contrast-enhanced magnetic resonance imaging dm - diabetes mellitus ekg - echocardiography hfpef - heart failure preserved left ventricular ejection fraction lvef - left ventricular ejection fraction
comparative efficacy of pregabalin and lacosamide in patients with herpes zoster and post herpetic neuralgia

Conditions: Herpes Zoster (HZ); Post Herpetic Neuralgia (PHN)

Summary: post-herpetic neuralgia (phn) is the most significant complication of herpes zoster caused by reactivation of latent varicella-zoster virus (vzv). phn is characterized by neuropathic pain lasting beyond the resolution of the rashes. post herpetic neuralgia (phn) represents a potentially debilitating and often undertreated form of neuropathic pain that disproportionately affects vulnerable populations, including the elderly and the immunocompromised. phn pain is typically localized, unilateral and chronic, but may be constant, intermittent, spontaneous and/or evoked. phn is likely to interfere with sleep and daily activities. pregabalin is a gabapentinoid licenced for treatment of neurological disorders. it is one of the earlier drugs approved by the us food and drug administration (2004) for the treatment of painful diabetic neuropathy and postherpetic neuralgia (phn). lacosamide (lcm) was approved in 2008 in the european union and in the united states as adjunctive therapy for the treatment of focal-onset seizures with or without secondary generalization in adults and adolescents with epilepsy. its efficacy has also been proven in neuropathic pain. although pregabalin and lacosamide have proven effective in various neuropathic pain disorder, comparative studies specifically for phn remain scarce. this study aims to compare the efficacy of pregabalin and lacosamide in phn patients, addressing the current gap in literature and providing clinically relevant insights to optimize treatment selection.


Eligibility criteria:
inclusion criteria: * diagnosed cases of herpes zoster suffering from postherpetic neuralgia * ages: 18 to 50 * both male and female exclusion criteria: * lack of consent * patient already taking pain killers for post herpetic neuralgia * patients suffering from other systemic illness
investigating the periodontal status of traditional and heated tobacco product users

Conditions: Gingivitis and Periodontal Diseases

Summary: this cross-sectional observational study aims to compare the clinical and radiographic periodontal status, as well as gingival crevicular fluid volume, among cigarette smokers, heated-tobacco product users, and non-smokers. specifically, the aim is to determine whether tobacco product users exhibit worse clinical parameters-such as probing pocket depth, bleeding on probing, plaque index, clinical attachment loss-along with greater radiographic bone loss and higher gingival crevicular fluid volume than non-smokers.

smoking is one of the main risk factors of periodontitis and its harmful effects on periodontal health are now well known. thanks to worldwide restrictions, the use of traditional cigarettes is declining, but new alternative tobacco products such as heated tobacco products (e.g. iqos, glo) have appeared on the market. these devices are often perceived less harmful by consumers, but there are conflicting results in the literature regarding their health effects. only one study has assessed periodontal health in heated tobacco product users, but in this study all participants were former smokers. no studies have evaluated periodontal health in heated tobacco users without a history of smoking traditional cigarettes on a regular basis. therefore, the aim of the present cross-sectional observational study is to compare the clinical and radiographic periodontal status and gingival crevicular fluid (gcf) volume among cigarette-smokers, heated-tobacco product users and non-smokers. the null hypothesis is that different tobacco product users have worse clinical and radiological periodontal parameters and higher gcf volume than non-smokers. the study will be performed at the department of prosthodontics at semmelweis university, budapest, hungary. patients will be enrolled from the patient material of the department of prosthodontics.

Eligibility criteria:
inclusion criteria: * smokers who smoke at least one cigarette daily for the past 12 months. * exclusive users of heated tobacco products (e.g., iqos), using them at least once daily for the past 12 months and not regular traditional cigarette smokers. * non-smokers who have never consumed tobacco in any form. exclusion criteria: * users of electronic cigarettes, smokeless tobacco, waterpipes, or any other tobacco products. * dual users of tobacco products. * individuals diagnosed with systemic diseases. * edentulousness or severe tooth loss (fewer than 20 remaining teeth). * individuals who have taken antibiotics, steroids, or non-steroidal anti-inflammatory drugs in the past 90 days. * pregnant or breastfeeding women. * history of periodontitis. * individuals refusing to sign the written informed consent form. * third molars are excluded from examination.

Keywords: smoking heated tobacco products periodontal diseases
the effect of exercise training on musculoskeletal health in individuals with cerebral palsy

Conditions: Cerebral Palsy

Summary: cerebral palsy (cp) is a neurodevelopmental disorder and is the most common childhood disability. cp is characterized by abnormal development, impaired motor function, and muscular and skeletal abnormalities. due to their diminished musculoskeletal function, individuals with cp suffer a high rate of moderate to severe bone fractures, which can lead to further immobility. optimizing muscle and bone health with exercise may be important in minimizing fractures from limited mobility, and fundamental for maximizing health-related quality of life. the main purpose of this research is to investigate the effect of exercise training on musculoskeletal system in individuals with cp, with the goal of reducing the incidence of falls and fractures. to accomplish these aims, musculoskeletal health will be assessed using various physiological techniques (e.g., dual energy x-ray absorptiometry, humac norm isokinematic system, biodex balance system) before, during, and after one year of exercise training in individuals with cp. in addition, various functional mobility tests to quantify fitness levels will be performed. findings may lead to the development of novel therapeutic interventions targeted at improving musculoskeletal health in individuals with cp.


Eligibility criteria:
inclusion criteria: * those who can follow simple commands and walk independently with or without the use of an assistance apparatus (within classification level i-iii, based on gross motor functioning classification system, gmfcs) and have cerebral palsy will be included in the study. the rationale for such inclusion criteria (level i-iii) is to make sure they can perform some leg exercise and tests. exclusion criteria: * if subjects have a history or symptoms of cardiovascular, renal, hepatic, or respiratory diseases, they will be excluded in the study.
clinical use of cold and contact heat-evoked potentials: normative values

Conditions: Establishing Normative Values of Cold and Contact Heat-evoked Potentials

Summary: this prospective interventional study aims at recording contact heat evoked potentials (cheps) and cold evoked potentials (ceps) in a healthy population sample in an aim to derive normative values which could be used to evaluate evoked potentials (eps) of patients.

population sample of 80 healthy volunteers between 26 and 75 years old will be recruited and will be categorized into 5 age subgroups (26-35, 36-45, 46-55, 56-65, 66-75 years old). upon arrival, participants will be reminded of the aims and of the content of the experiment. after informed consent (recorded in writing), healthy subjects will be screened with a baseline examination: 1. brief neurological examination 2. sensory nerve conduction study-related 3. quantitative sensory testing if the baseline examination screening is considered normal, ceps and cheps will be performed. to avoid bias, the side and order of the tests will be randomized. all thermal stimuli for ceps and cheps will be delivered delivered using a contact thermal stimulator (tcs model ii.1, qst.lab, strasbourg, france). only stimuli that are safe and acceptable for the subject will be used in the study, and all experimental procedures can be interrupted at any time by the participant, with no detrimental effect.

Eligibility criteria:
inclusion criteria: * healthy volunteers between 26 and 75 years old having a normal baseline testing. exclusion criteria: * age\ 75 years old * known neurological condition. * acute or chronic pain condition. * currently taking drugs that may influence the recording of evoked potentials (analgesics, psychotropic substances, antiepileptics...). * history of neurological, or metabolic disorder. * inability to complete study task. * history of chemotherapy. * habitual substance abuse(alcoholic beverages intake \>21 units/week for males, \>14 units/week for females.) * being a volley ball player (due to risk of modified sensibility of the volar forearm skin) * abnormal baseline neurological, snc or qst testing

Keywords: healthy participants
efficacy/safety of amlodipine plus losartan versus amlodipine in patients with stage 2 hypertension

Conditions: Hypertension

Summary: the purpose of this study is to evaluate the blood pressure lowering effects of an amlodipine/losartan combination treatment and amlodipine monotherapy for treatment of stage 2 hypertensive patients.


Eligibility criteria:
inclusion criteria: * 18 aged or over * patients with blood pressure measured at visit 1; mssbp≤180mmhg and msdbp≤110 mmhg if on anti-hypertensive drugs, 160mmhg≤mssbp≤199mmhg and 80mmhg≤msdbp≤119mmhg if not on anti-hypertensive drugs * patients with blood pressure measured at visit 2 were 160mmhg≤mssbp≤199mmhg and 80mmhg≤msdbp≤119mmhg exclusion criteria: * inability to stop all prior anti-hypertensive drugs safely during wash out period of 3 to 7 days * ≥ sitsbp 20mmhg or ≥ sitdbp 10mmhg of variation in three measurements from the reference arm selected at screening * history of hypersensitivity to dihydropyridines, angiotensin ii receptor blockers or thiazide diuretics * secondary hypertension or suspected to be * continuously took medicinal drugs that might affect blood pressure rather than anti-hypertensive drugs more than 3 months * type 2 diabetes mellitus which is not controlled or with type 1 diabetes mellitus * history of severe neurovascular disease, severe heart disease * known as moderate or malignant retinopathy. * renal diseases; serum creatinine ≥ 2mg/dl * hepatic diseases; increase in alt or ast ≥ 2xunl * anuria * hyponatremia/hypokalemia or hypercalcemia * active gout * surgical or medical diseases which might significantly change adme of medicines * history of malignant tumor * autoimmune diseases * history of alcohol or drug abuse * positive to pregnancy test, nursing mother, woman with an intention of pregnancy * considered inappropriate to participate in the clinical trial with any reason, based on investigator's decision other protocol-defined inclusion/exclusion criteria may apply

Keywords: amlodipine losartan hypertension stage 2
influenza resistance information study

Conditions: Influenza

Summary: this study will assist in the early detection of influenza resistant to antivirals and will monitor the clinical outcome of adults and children infected with influenza according to subtype and susceptibility. participants clinically diagnosed with influenza will undergo a rapid diagnostic test and viral sampling at baseline and on days 3, 6, and 10. participants will be clinically managed according to local guidelines and the decision to treat/not treat will be at the discretion of the investigator.


Eligibility criteria:
inclusion criteria: * participants greater than or equal to (≥) 1 year of age with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness (during years 1 to 5) * participants less than or equal to (≤) 12 years of age with a positive diagnostic test of influenza and displaying symptoms suggestive of influenza-like illness and who are being or, according to local standard of care, will be treated with an influenza antiviral (during years 6 and 7) exclusion criteria: * allergy to any potential influenza therapy * living in the same household or residential/care home as another study participant
long term extension of safety and efficacy of vagus nerve stimulator in patients with rheumatoid arthritis (ra)

Conditions: Rheumatoid Arthritis

Summary: long-term extension of a multi-site, first-in-human study to assess safety and efficacy of an active implantable vagus nerve stimulation (vns) device in adult patients with active moderate-to-severe rheumatoid arthritis who have had an incomplete response or intolerability to at least two biologic and/or targeted synthetic dmards having at least two different mechanisms of action

a multicenter, extension study to assess long term safety and efficacy of an active implantable vns device in adult patients with rheumatoid arthritis. the study is uncontrolled and randomized, where the sites and subjects are blinded to treatment until completion of the parent study. subjects who were randomized to the inactive device group in the parent study are re-randomized to receive active vagus nerve stimulation either 1 min qd or 1 min qid. subject who were randomized to the active device groups remain on their assigned treatment (1 min qd, 1 min qid). study treatment in spm-011 begins at the day 0 visit. at the day 0, week 1, 2, 3, 4 and 5 visits, all subjects are given the opportunity to have the output current of their implant adjusted to the maximum level tolerated. from week 5 onward, subjects will receive their maximally tolerated output current as 1 min qd or 1 min qid treatment. follow up assessment visits occur at week 8, week 12, months 6, 9, 12, 18, 24, 30, 33 and 36. subjects are assessed for safety and durability of response throughout the follow up period. if the subject's symptoms or ra disease worsens, additional concomitant medications are allowed for treatment of their ra.

Eligibility criteria:
inclusion criteria: 1. subjects must have enrolled and completed 12 weeks of treatment in study spm-008 2. women of childbearing potential must not be pregnant and must agree to use a reliable method of contraception throughout the study exclusion criteria: 1. inability to provide consent 2. an adverse event during study spm-008 which precludes participation in this study 3. any condition per the investigator's clinical judgement that precludes participation in the study
auditory verbal hallucinations in schizophrenia

Conditions: Schizophrenia

Summary: auditory verbal hallucinations (avhs) are speech perceptions in the absence of a relevant external stimulation. some accounts of avhs claim that a deficit in inner speech monitoring would cause the verbal thoughts of the patient to be perceived as external voices resulting in avhs. in order to examine whether avhs correspond to self-generated inner speech, the present study aims at collecting speech muscle activity during covert avhs (without articulation), overt speech and rest. surface electromyography (semg) is used on schizophrenia patients and control subjects to detect any speech muscle activity during avh.


Eligibility criteria:
inclusion criteria: healthy controls: * must be more than 18 years and less than 60 years old * pre-inclusion medical examination * must have signed consent form * must be able to read stimuli on a screen schizophrenia patients: * must be more than 18 years and less than 60 years old * pre-inclusion medical examination * must have signed consent form * must be able to read stimuli on a screen * diagnosed with a schizophrenia disorder according to dsm-iv tr (diagnostic and statistical of mental disorders) (panss item p3 greater than 4) * prior evaluation of the secondary effects of any medication via barnes and aims scales * affiliated with the french social security * if under guardianship, must have additional consent form signed by guardian exclusion criteria: healthy controls: * if aged less than 18 years or more than 60 years * diagnosed with any psychiatric disorder * with any language disorder (aphasia, sli, dysarthria, stuttering, etc.) * with auditory impairment * pregnant, parturient, breast-feeding schizophrenia patients: * if aged less than 18 years or more than 60 years * significant secondary effects of antipsychotic medication, measured with the barnes and aims scales * with a neurodegenerative disease * with any language disorder (aphasia, sli, dysarthria, stuttering, etc.) * with auditory impairment * pregnant, parturient, breast-feeding