Kornimate/medical-research-clean huggingface dataset:
study to investigate safety, tolerability, pk and pd response of sln360 in subjects with elevated lipoprotein(a)

Conditions: Hyperlipidemias; Dyslipidemias; Elevated Lp(a)

Summary: this study will investigate the safety and tolerability of sln360 in patients with elevated lp(a).

this first-in-human (fih) study will investigate the safety, tolerability, pharmacokinetics (pk) and pharmacodynamics (pd) of sln360 after single ascending s.c. doses and multiple doses in healthy male and female subjects. up to 9 cohorts of 88 patients with elevated lp(a) will be enrolled. each patient will receive single or multiple doses of sln360 or placebo given by subcutaneous (s.c) injection.

Eligibility criteria:
inclusion criteria: * elevated plasma lp(a) ≥ 150nmol/l. * all subjects must agree to adhere to appropriate contraception requirements. * subjects must provide written informed consent and be able to comply with all study requirements. * body mass index of ≥ 18 kg/m2 and ≤ 45 kg/m2. * for the md part: confirmed history of stable atherosclerortic cardiovascular disease. exclusion criteria: * single ascending dose only: any history of clinically overt cardiovascular disease, defined as acute coronary syndromes, myocardial infarction, stable angina, coronary or other revascularization, ischemic stroke or transient ischemic attack and atherosclerotic peripheral arterial disease. * multiple dose only: recent history of acute cardiovascular disease events within 6 months of screening (including, but not limited to, acute myocardial infarction, unstable angina, acute stroke and acute limb ischemia). * moderate or severe hepatic cirrhosis with child-pugh grade b or c, or other current or previous liver disease. * active serious mental illness or psychiatric disorder, including but not limited to schizophrenia, bipolar disorder, or severe depression requiring current pharmacological intervention. * any conditions which, in the opinion of the investigator, would make the subject unsuitable for enrolment in the study or could interfere with the subject's participation in, or completion of the study. * subjects with previous or current use of medication or therapies significantly affecting lp(a) level or hormone replacement therapy, unless on a stable dose for ≥ 8 weeks prior to screening * history or clinical evidence of alcohol or illegal drug misuse within the 6 months before screening. * history of multiple drug allergies or history of allergic reaction to an oligonucleotide or galnac, or intolerance to s.c. injections.

Keywords: dyslipidemia, dyslipoproteinemia, hyperlipidemia, hyperlipoproteinemia, hyperlipoproteinemia (a), lipoprotein, lipoprotein (a)
detection of area of ischemia in patients with subacute stroke via a hybrid eeg-fnirs brain-computer interface

Conditions: Stroke

Summary: the purpose of this research study is to determine whether a combined electroencephalography (eeg) and functional near infrared spectroscopy (fnirs) recording is able to detect changes in brain activity and blood flow after stroke.


Eligibility criteria:
inclusion criteria: * all patients with a subacute ischemic stroke with symptom onset within 8 weeks * must have a measurable deficit on the national institute of health stroke scale (nihss) * able to give and sign informed consent exclusion criteria: * aphasia * underlying dementia * any chronic neurological disorder * malignancy * non-ambulatory (ambulation with assistance will be included) * modified rankin score (mrs) \> 3
clinical trial of the optimal endpoint of early sepsis resuscitation

Conditions: Severe Sepsis; Septic Shock

Summary: the purpose of this study is to determine if there is equivalence between two different methods of treating patients with severe bloodstream infection called sepsis. we will randomly assign patients to one of two treatment methods. one of the treatment methods is the current standard of care and uses an infrared sensor on the end of a catheter to determine the adequacy of treatment. the second treatment method is identical to the first but instead of the infrared sensor a blood test that is performed as a part of standard care (with blood drawn from the catheter) will be used to determine the adequacy of treatment. this study will attempt to determine an easier method of guiding treatment.


Eligibility criteria:
inclusion criteria: 1. suspected infection 2. any two of four criteria of systemic inflammatory response 3. sbp \ 4 mmol/l (severe sepsis). exclusion criteria: 1. age \< 18 years 2. pregnancy 3. established "do not resuscitate" orders prior to enrollment 4. primary diagnosis other than sepsis 5. requirement for immediate surgery in \< 6 hours from admission 6. any absolute contraindication to central venous catheterization

Keywords: sepsis shock emergency department resuscitation
snord3a in ischemic heart disease and heart failure

Conditions: Ischemic Heart Disease; Heart Failure

Summary: this is a prospective, non-randomized, single center, open label clinical study enrolling patients affected by 1) chronic ischemic heart disease with evidence or suspect significant myocardial ischemia (group 1, ccs) or 2) acute coronary syndromes (group 2, acs), both undergoing coronary angiography and eventually coronary revascularization at the department of scienze cardiovascolari, diagnostica per immagini ed emergenze cardiovascolari of federico ii university hospital, naples, italy. age and sex-matched healthy volunteers without known ischemic heart disease (group 3, ctr) will also be included as a control group. at enrollment (time 0), and after 48 hours (time 48 h), 1 month (time 1mo) and 6 month-follow-up visits (time 6 mo), clinical evaluation, ecg, trans-thoracic echocardiography and blood sampling will be performed, to isolate peripheral blood mononuclear cells (pbmc) and perform standard blood tests. the enrolment phase will last 24 months, and will likely involve 450 patients distributed as follows, according to the number of patients annually referring to our university hospital: 1. group 1, n= 200 patients with chronic ischemic heart disease undergoing coronary angiography and eventually coronary revascularization; 2. group 2, n= 200 patients with acs undergoing coronary angiography and eventually coronary revascularization ; 3. group 3, n= 50, healthy volunteers.


Eligibility criteria:
inclusion criteria: group 1: history (\> 6 months) of ischemic heart disease (prior myocardial infarction, prior percutaneous coronary intervention, prior surgical revascularization) and clinical or imaging evidence of chronic moderate or severe myocardial ischemia group 2: patients with acute coronary syndromes at presentation including st-elevation myocardial infarction, non-st elevation myocardial infarction, and unstable angina. group 3: healthy volunteers with no prior history of ischemic heart disease or clinical/imaging evidence of myocardial ischemia. exclusion criteria: patients unwilling to provide informed consent to participate to the study * concomitant primary cardiomyopathies or hemodynamically significant heart valve disease * treatment with cancer or antibiotic therapies affecting ribosomal structure or function.
surgery plus intraoperative radiotherapy as treatment for squamous cell carcinoma over pilonidal disease.

Conditions: Squamous Cell Carcinoma; Pilonidal; Cyst, Malignant; Surgery

Summary: background: pilonidal sinus is a very common disease. malignant transformation occurs in 0,1% of patients. the investigators present a case of squamous cell carcinoma arised from recurrent pilonidal disease, managed by multimodal treatment. case presentation: the investigators present a 70-year-old man with chronic pilonidal sinus. inflammation had worsened in previous months and exploration revealed a large ulcerative mass which biopsy showed a squamous cell carcinoma. ct scan and mri imaging showed tumoral invasion of the coccyx and both gluteus major muscles. neoadjuvant radiotherapy, chemotherapy as radiosensitizer and surgery with intraoperative radiotherapy was decided in the multidisciplinary tumor committee. post neoadjuvant therapy mri showed partial response with a decrease of the mass but persistence of the coccyx infiltration. surgery consisted in en-bloc resection of the tumor with presacral tissues, coccyx and partial gluteal resection. intraoperative radiotherapy was administered over the sacrum and in the bed of the coccyx resection. one week later, reconstructive surgery was practiced using a latissimus dorsi free flap, advancement of gluteal flaps and skin graft. histological examination showed no residual tumor. the patient is currently asymptomatic and he has a satisfactory quality of life. conclusions: although squamous cell carcinoma is rare, it must be suspected in patients with recurrent pilonidal disease. diagnosis is done by histological examination of biopsies. this type of tumors have a high local recurrence rate. the investigators propose a multimodal treatment that includes neoadjuvant radiotherapy and chemotherapy as radiosensitizer and surgery plus intraoperative radiotherapy with the aim to decrease local recurrence rate.


Eligibility criteria:
inclusion criteria: * squamous cell carcinoma over pilonidal disease exclusion criteria: * distant metastases

Keywords: pilonidal sinus squamous cell carcinoma surgery intraoperative radiotherapy chemotherapy
disposable powered articulating linear cutter stapler in total-thoracoscopic anatomic lobectomy (segmentectomy)

Conditions: Lung Cancer

Summary: to evaluate whether the anastomosis success rate of the main effectiveness evaluation indexes is not inferior to the similar products produced by johnson \& johnson when the fengh disposable powered articulating endoscopic linear cutter stapler used for thoracoscopic anatomic lobectomy (segmentectomy)

by comparing the effectiveness and safety of the disposable electric-endoscopic linear cutter stapler and cartridge (the subject product) produced by jiangsu fengh medical co., ltd. and the similar product (electric-endoscopic linear cutter stapler with articulating head) produced by johnson \& johnson in total-thoracoscopic anatomic lobectomy (segmentectomy), to prove that the subject product can be used for pulmonary tissue resection and anastomosis, and that the clinical trial meets the requirements of good clinical practice for medical devices, guidelines for clinical trial design of medical devices and guidelines for technical review of endoscopic stapler registration, which can be used for product registration application.

Eligibility criteria:
inclusion criteria: 1. subjects aged 18-70 (inclusive), with no gender limitation; 2. the subject plans to undergo thoracoscopic anatomic pulmonary lobectomy (pulmonary segment); 3. subjects or their guardians can understand the purpose of the study, show sufficient compliance with the study protocol, and sign the informed consent. exclusion criteria: 1. subjects have contraindications of video-assisted thoracoscopy; 2. the preoperative imaging results of the subjects indicated the presence of severe pleural adhesion and significant calcified hilar lymph nodes; 3. subjects' platelet (plt) \ 1.5; 4. subjects forced expiratory volume in 1 second (fev1)/expected value ≤50%, or forced expiratory volume in 1 second (fev1)/use vital capacity (fvc)≤60%; 5. cardiac ejection fraction ≤50%; 6. major organ failure or other serious diseases (including clinically relevant cardiovascular diseases or within 12 months prior to enrollment) myocardial infarction; a history of severe neurological or psychiatric illness; the presence of a serious infection before surgery that must be controlled with medication; dissemination of activity sexual intravascular coagulation; at high risk of blood clots); 7. the subject is a pregnant or lactating woman; 8. the subject participated in clinical trials of other drugs or devices within 1 month prior to the trial; 9. other conditions that the researcher judged inappropriate for inclusion. .
fibromyalgia in rheumatiod and psoriatic patients

Conditions: Fibromyalgia, Secondary

Summary: the study based on investigate for fibromyalgia among rheumatiod arthritis patient and psoriatic arthritis.....and to what extent gibromyalgia affect disease activity indices ....and its relation to serum vitamin d level in those patients


Eligibility criteria:
inclusion criteria: - adult onset disease any patient diagnosed as rheumatiod arthritis and psoriatic arthritis above18years old exclusion criteria: * any other autoimmune diseases
does improvement towards a normal cervical sagittal configuration aid in the management of lumbosacral radiculopathy

Conditions: Cervical Lordosis Rehabilitation

Summary: a randomized controlled study with six months follow-up will be conducted to investigate the effects of sagittal head posture correction on 3d spinal posture parameters, back and leg pain, disability, and s1 nerve root function in patients with chronic discogenic lumbosacral radiculopathy . participants will include 80 patients between 40 and 55 years experiencing chronic discogenic lumbosacral radiculopathy with a definite hypolordotic cervical spine and forward head posture and will be randomly assigned a comparative treatment control group and a study group. both groups will receive tens therapy and hot packs, additionally, the study group will receive the denneroll cervical traction orthotic.

despite the fact that there is some evidence of a link between low back pain and head posture , there is limited experimental data to support a cause-and-effect relationship and interventional outcomes. accordingly, a prospective, randomized, controlled study will be conducted at a research laboratory of our university to investigate if cervical curve restoration and forward head posture correction will have short and long term effects on three dimensional spinal posture parameters as well as lumbar radiculopathy management outcomes such as symptoms, disability, and neurophysiological findings .in this study we will use an orthotic cervical traction termed the denneroll to help restore normal sagittal spinal configuration based on principles of 3-point bending traction methods. interventions will be applied at a frequency of 3 times per week for 10 weeks and groups will be followed for an additional 6-months.

Eligibility criteria:
inclusion criteria: * absolute rotatory angle less than 25° and greater than 0. * anterior head translation distance greater than 15mm * confirmed chronic unilateral lumbosacral radiculopathy associated with l5-s1 lumbar disc prolapse . * symptoms lasting longer than 3 months exclusion criteria: * previous history of lumbosacral surgery. * metabolic system disorder. * peripheral neuropathy. * history of upper motor neuron lesion. * spinal canal stenosis. * rheumatoid arthritis. * osteoporosis

Keywords: lumbosacral radiculopathy disc herniation cervical lordosis
educational intervention using sms to evaluate clinical effects and satisfaction in patients with diabetes mellitus

Conditions: Educational Problems

Summary: the investigators evaluated the satisfaction of these patients with the health service and their self-care. the study included patients diagnosed with dm, respecting the established inclusion and exclusion criteria. participants were randomized into the control group and the intervention group.

patients with diabetes mellitus (dm) have greater control over the disease when they acquire some knowledge about it. in this context, the use of technology by health professionals for nutritional guidance and self-care has shown promising results. this study aims to evaluate the impact of these educational approaches via sms on glycemic control of patients with dm, followed at the endocrinology outpatient clinic of the antonio pedro university hospital (huap). also, the investigators evaluated the satisfaction of these patients with the health service and their self-care. the study included patients diagnosed with dm, respecting the established inclusion and exclusion criteria. participants were randomized into the control group and the intervention group. the patients in the intervention group received weekly sms for six months, with dietary guidelines and dm care. both groups answered a questionnaire at the beginning and end of the intervention, which consisted of assessing satisfaction with the health service received and their care for dm. similarly, the investigators collected their clinical and laboratory data from medical records at the beginning and end of the intervention.

Eligibility criteria:
inclusion criteria: * diabetes exclusion criteria: * non diabetes
evaluation of il-33 in patients with the acute ischemic stroke

Conditions: Ischemic Stroke

Summary: aim of the study is to evaluate the usefulness of interleukin 33 in the blood plasma in patients with the acute ischemic stroke of the brain in relation to mode of treatment (thrombolysis, thrombectomy, no treatment), risk factors in correlation with other inflammatory state markers (hscrp, morphology with smear ). blood is collected on the first and seventh days of stroke. the purpose is to clarify utility of il 33 as a biomarker of acute stroke.

stroke is the third most frequent cause of death in highly developed countries (after heart disease and cancer), the main cause of disability in adults and the second most frequent cause of dementia syndromes. the annual incidence of stroke in the general population is approximately 0.2%. the risk of stroke increases with age. globally 15 million people are affected each year and 5.5 million die every year for this reason (20% in 30 days and up to 40% in a year from getting ill). in poland, the incidence of stroke is around 175/100,000 in men and 125/100 in women.it is assumed that the cause of sudden cerebral insufficiency is mainly the embolism coming from the newly formed wall clot forming at the site of the atherosclerotic plaque rupture. in recent years, the role of inflammatory factors is associated with the occurrence of severe atherosclerotic complications such as stroke or heart attack. cytokines are glycoproteins that are released by activated cells of various tissues. they have a significant impact on the inflammation processes, they control all phases of the immune response. interleukin is one of the cytokine groups. this study aims to find a relationship between level of il 33 concentration and the size of the stroke and neurological deficit. blood will be collected on the first and seventh days of stroke for examination of il 33, blood morphology and hscrp

Eligibility criteria:
inclusion criteria: * age over 18 * consent on participation * diagnosed ischemic stroke exclusion criteria: * active cancer disease * kidney failure * liver failure * pregnancy * breastfeeding

Keywords: ischemic stroke interleukin 33 astral dragon nihss
knowledge, attitudes, and practices towards covid-19 among health care professionals among healthcare professionals

Conditions: COVID; Knowledge, Attitudes, Practice

Summary: the aim of this study is to evaluate the knowledge level of healthcare professionals such as physicians, nurses, physiotherapists and nutritionist about published covid-19 guidelines. the listed healthcare workers are take part in the primary treatment of the corona virus infected patients in hospitals. therefore the knowledge of the world wide spreading corona virus and its effects for the human being is should be known for the effective treatment and for raising public awareness.


Eligibility criteria:
inclusion criteria: * physicians, nurses, physiotherapists and other healthcare professionals with clinical practical experience * actively working in the hospitals and in any health institution exclusion criteria: * employees outside the health area * health professionals who do not work in any health institution * employees who do not have a bachelor's degree

Keywords: health care professionals
effectiveness of er:yag pulse therapy for achieving pre-emptive dental analgesia in children

Conditions: Caries, Dental

Summary: the aim of this study is to determine the effectiveness of er:yag pulse therapy for achieving pulpal analgesia in pediatric patients and to quantify the duration and extent of any effects assessed. design: a randomized split-mouth study with two-way repeated measures design.

the intention of the technique of "pre-emptive laser analgesia" is to reduce sensation in that small percentage of patients who may experience unpleasant sensations during caries removal. laser analgesia is a non-invasive, non-thermogenic bio-modulation of the dental pulp reactivity aiming for reduction of impulse formation of the pulpal nociceptors. it is based on the idea that parallel with the ablative high-energy level laser action, simultaneous low level laser therapy (lllt) may occur. we hypothesize that when operating at pulse energies below the er:yag laser ablation threshold of tooth structure, the laser energy leads to loss of impulse conduction of type a-delta nerve fibers in the dental pulp, leading to an analgesic effect.

Eligibility criteria:
exclusion criteria: * children who are considered medically compromised or medically complex patients. the absence of disease is confirmed by anamnestic interview with a parent or a care-giver of the child and excludes general acute or chronic disease, cognitive impairment, psychogenic nonepileptic events, radiotherapy in the maxillofacial region due to malignant process. * patients who are undergoing therapy with neurological, sedative, analgesic and/or anti-inflammatory drugs 7 days prior to treatment. * children, who are first time ever dental patients. inclusion criteria: * patients, identified as positive or definitely positive through frankl behavioral rating scale. * patients who are not undergoing treatment or have been treated 6 months prior to inclusion with remineralizing agents. * patients, requiring conservative treatment of occlusal, caries on foramen caecum, and/or proximal caries on two first permanent upper jaw molars without prior restorations or dental sealants. lesions are to be classified as moderate caries by the international caries detection and assessment system (icdas) with code 03 or code 04, which do not present spontaneous unprovoked pain, percussion or palpation pain or other symptoms, indicating of pulpal pathology. included are carious lesions only on vital teeth, involving up to half of the dentine thickness, with no periodontal pathology. laser fluorescence diagnosis of adjacent lesions with diagnodent is limited to 20 - 35 scores included. * included are first molars which are not affected by hypoplasia or hypomineralization. obtained informed consent from parents or gave-givers to participate in the study, in which laser treatment and study procedures are explained in appropriate manner.

Keywords: laser analgesia pediatric dentistry