Kornimate/medical-research-clean huggingface dataset:
immunogenicity of after primary immunization and booster immunization of sipv

Conditions: Polio

Summary: this study was conducted on the basis of "safety observation of sabin strain inactivated polio vaccine (vero cell) on primary immunization, booster immunization and simultaneous vaccination with other vaccines in infants and young children(id: pro-sipv-ma4001-jx). blood samples were collected in about 200 qualified subjects 1-9 months after their last vaccination of sipv. and immunogenicity of sipv and other vaccines simultaneously administrated will be tested, the antibodies against enterovirus (including ev71、ca16、ca6 and ca10) will also be tested.


Eligibility criteria:
inclusion criteria: * participated in the previous study (id: pro-sipv-ma4001-jx) * subjects in the primay immunization group(aged 2-3 months) need to complete 3 doses of sipv vaccination, and the simultaneous vaccination group dtap needs to complete 3 doses of vaccination; the booster immunity group(aged more than 18 months) needs to complete sipv vaccination, and the simultaneous vaccination group needs to complete the corresponding vaccination; * there should be an interval of 1-9 months between the last dose of vaccination and the date of blood sample collection; * the guardian of subjects need to agree to sign the informed consent form. exclusion criteria: * the interval between vaccination and blood collection is less than 1 month, or more than 9 months; * subjects were participating in other clinical studies of vaccines or drugs; * other conditions that make subjects unsuitable for participating in this study judged by investigator's

Keywords: immunogenicity of sipv primary immunization booster immunization simulteneous immunization serology of antibodies against enterovirus
safety follow-up to hp 802-247-09-015

Conditions: Venous Leg Ulcer; Venous Stasis Ulcer

Summary: this is a 24-week observational follow safety study for study 802-247-09-015.

the objective of this study is to examine the durability of previous target wound closures, identify new test article-related adverse events, record new target wound closures, and examine ongoing adverse events not resolved in subjects who participated in hp 802-247-09-015.

Eligibility criteria:
inclusion criteria: * provide informed consent * willing to comply with protocol instructions, including allowing all study assessments. * subject was randomized in hp 802-247-09-015 and received at least one application of a test article, whether active or placebo. * subject has ended their participation in hp 802-247-09-015 by virtue of completing the study, or by dropping out prior to completion. exclusion criteria * subjects who refuse to provide written informed consent will be excluded from this trial.

Keywords: venous leg ulcer venous stasis ulcer vlu vsu leg ulcer leg wound
nox-e36 first-in-human (fih) study

Conditions: Chronic Inflammatory Diseases; Type 2 Diabetes Mellitus; Systemic Lupus Erythematosus

Summary: this is the first time nox-e36 will be administered to man. the principal aim of this study is to obtain safety and tolerability data when nox-e36 is administered by single intravenous (iv) and subcutaneous (sc) doses to healthy male and female subjects. this information, together with the pharmacokinetic and pharmacodynamic data, will help establish the doses, dosage regimen and route of administration suitable for multiple dose administration to healthy volunteers, followed by the studies in the patient population.


Eligibility criteria:
inclusion criteria: * healthy male and female subjects * body mass index (bmi) between 19.0 and 29.0 kg/m2 inclusive * body weight between 50 and 100 kg inclusive * creatinine clearance of greater than 80 ml/min exclusion criteria: * male and female subjects who are not or whose partners are not willing to use appropriate contraception methods * intake of any prescribed systemic or topical medication within 14 days prior to dosing * intake of any non-prescribed systemic or topical medication (including herbal remedies) within 7 days prior to dosing (with the exception of vitamin/mineral supplements) * supine blood pressure and supine pulse rate higher than 140/90 mmhg and 100 beats per minute (bpm), respectively, or lower than 90/50 mmhg and 40 bpm, respectively, as confirmed by a repeat assessment * history of any clinically significant neurological, dermatological, gastrointestinal, renal, hepatic, cardiovascular, psychiatric, respiratory, metabolic, endocrine, haematological or other major disorders

Keywords: monocyte chemoattractant protein-1 (mcp-1) l-oligonucleotide aptamer spiegelmer
evaluation of ldl cholesterol in patients switched from 10 to 5 milligrams of zetia (ezetimibe)

Conditions: Hypercholesterolemia

Summary: the purpose of this study is to compare the effect on ldl cholesterol levels of converting patients who are receiving the cholesterol absorption inhibitor zetia at a dose of 10 milligrams to 5 milligrams, when prescribed as a split 10 milligram tablet.


Eligibility criteria:
inclusion criteria: * subjects receiving ezetimibe 10 mg * subjects who have demonstrated compliance with ezetimibe as evidenced by the following proportions of days covered patterns (which represent a pdc of more than 75%): * 90 day prescriptions: filled a ezetimibe prescription within the previous 4 months * 60 day prescriptions: filled a ezetimibe prescription within the previous 2.5 months * 30 day prescriptions: filled a ezetimibe prescription within the previous 1.5 months * patients willing and able to provide signed informed consent exclusion criteria: * patients not receiving ezetimibe * patients receiving ezetimibe 5 milligrams * patients with a history of being titrated from ezetimibe 5 to 10 mg. stroke,tia, myocardial infarction, unstable angina, percutaneous coronary intervention, coronary artery bypass surgery, or major surgery within the 3 months * cancer undergoing active treatment * participation in any clinical study within the last 30 days * drug addiction or alcohol abuse within the past 6 months * patients unwilling or unable to provide informed consent * patients with poor compliance * women of childbearing potential

Keywords: cholesterol ezetimibe
comparison of imes versus dn on atrps of ac

Conditions: Shoulder Pain

Summary: the aim of our study to compare dn and imes for pressure pain threshold, rom and the shoulder function in active trigger points with adhesive capsulitis. this study will add to the growing body of knowledge that if these two techniques yield comparable outcomes and if one technique is superior to the other, which should be the alternative of therapy. moreover, it would add to the society as there are very limited researches done in pakistan using needling for trigger points in adhesive capsulitis.


Eligibility criteria:
inclusion criteria: * age 40 to 60 year of both genders * diagnosed patients of stage 3 adhesive capsulitis with type i and ii diabetes * involvement of at least 3 shoulder girdle muscles in active mtrps (subscapularis, latissimus dorsi, deltoid (anterior, middle, posterior) * active mtrps in shoulder girdle muscles (subscapularis, supraspinatus, deltoid (anterior, middle, posterior), teres minor, latissimus dorsi) * reproduction of the patient's symptoms at active trigger point, taut band, hypersensitive spot, referred pain pattern, local twitch response * minimum 60 degrees of active/passive shoulder abduction range of movement. exclusion criteria: * systemic inflammatory joint disease of shoulder joint (ra, oa polymyalgia rheumatic) * cerebral vascular accident * fibromyalgia, neurological deficits of upper limb (nerve root entrapment, cervical radiculopathy, thoracic outlet syndrome) * history of fracture, dislocation, acute soft tissue injury, acute bursitis * avascular necrosis of humeral head or visceral referred pain to shoulder * pregnancy, hypothyroidism, skin infection * patients who are using antiplatelet therapy with in past 3 days of study * extreme fear of needles

Keywords: trigger points range of motion dry needling disability
validation study of classintra®

Conditions: Patient Safety; Intraoperative Complications; Postoperative Complications; Risk Management

Summary: whereas there are several validated systems for reporting postoperative complications, there are only a few and not prospectively validated systems for reporting intraoperative complications. the investigators developed a definition and classification for intraoperative complications classic within a delphi study involving international interdisciplinary experts. as both surgery and anaesthesia may be involved in complications in the perioperative period, all patient-related intraoperative complications occurring between skin incision and closure are considered in this reporting system. classic was updated to classintra® v1·0, by encompassing five severity grades to align with the validated clavien-dindo classification for grading postoperative complications. the aim of this international multicentre observational cohort study is to assess the validity and practicability of this newly derived and updated classification system classintra® in patient undergoing an in-hospital surgical procedure. providing an easy applicable and internationally validated classification system is a contribution to improve quality of health care and patient safety.


Eligibility criteria:
inclusion criteria: * all in-hospital patients (consecutive or random sample) undergoing surgery in the operating room with anaesthesia involvement exclusion criteria: * outpatients (patients undergoing one-day-surgery) (with and without anaesthesia-involvement) * procedures without anaesthesia-involvement (in- or out-patient) * asa risk classification (asa) vi patients (brain-death organ-donor)
use of continuous passive motion in the post-operative treatment of intra-articular knee fractures

Conditions: Intra-articular Knee Fractures

Summary: decreased range of motion is common after fractures around the knee and can impact a patient's ability to perform activities of daily living such as rising from a seated position or getting in and out of a bathtub. a continuous passive motion (cpm) machine is a machine that continuously moves a joint (such as the knee) without the patient having to use the muscles in his/her leg. a goal of this therapy is to maintain as much motion as possible following this injury. this study is a randomized, prospective study to evaluate the effectiveness of cpm in maintaining knee range of motion following open reduction and internal fixation (orif) of fractures around the knee


Eligibility criteria:
inclusion criteria: * if the patient has an intra-articular distal femur or proximal tibia fracture * independent ambulatory prior to injury * no previous knee injury limiting motion exclusion criteria: * if the patients range of motion was decreased prior to injury (ex. osteoarthritis, previous knee fracture or injury) * any contraindication to cpm (concomitant hip or ankle fracture) * open physis of tibia or distal femur * pathological fracture * compartment syndrome * neurovascular injury * fracture due to gunshot wound * greater than 21 days from fracture to definitive open reduction and internal fixation * fractures treated with definitive external fixation * open fractures * extensor mechanism injuries * likely problems in the judgment of the investigator with maintaining follow-up
vagus nerve stimulation as treatment for long covid

Conditions: Long COVID; Chronic Fatigue Syndrome

Summary: many patients do not recover following covid infection. the resulting illness is called long covid. because there is no agreed upon treatment for this ailment, the research team has decided to do an open label pilot study using non-invasive, transcutaneous stimulation of the auricular branch of the vagus nerve. inclusion criteria required the patient to fulfill criteria for having chronic fatigue syndrome. to date, fourteen patients provided evaluable data. eight of these fulfilled the study's requirements for treatment success.

patients who have had covid and who fulfill criteria for chronic fatigue syndrome will sign ic and be mailed a parasym device with instructions its use after completing entry baseline questionnaires. subjects will be called two, four and six weeks after beginning participation \[application of electrode to left tragus with stimulus intensity at that which is just below pain threshold for 35 min a day\] to ask about adverse events. at the end of 6 weeks, patients will complete these questionnaires again plus one assessing their assessment of treatment efficacy.

Eligibility criteria:
inclusion criteria: * patients had to have had covid * patients have to fulfill the 1994 case definition for chronic fatigue syndrome. exclusion criteria: * bmi \> 30
pain control in bariatric patients: exparel(r) vs. the on-q(r) pain ball

Conditions: Obesity

Summary: this study was conducted to compare the effectiveness of two local pain control methods in bariatric patients by assessing the amount of postoperative pain and amount of postoperative pain medications needed. this information was used to determine which local anesthetic provided the best pain control.

the investigators have previously utilized the on-q® pain ball to obtain local control by continuous delivery of bupivacaine to pain fibers at the incision site. on-q makes use of an implanted catheter and a continuous infusion pump that the patient carries with them typically for 48-72 hours after surgery. exparel is a long-acting liposomal delivery vehicle that extends the life of bupivacaine in the surgical site for up to 72 hours. it can be injected in all trocar sites and offers another potential solution to patient pain control without the need for a catheter and the hardware needed to deliver the local anesthetic. patient nrs (numerical rating scale) scores for postoperative pain and total medication consumed were used to assess the differences between the two treatment groups.

Eligibility criteria:
inclusion criteria: * age 18-80, male or female exclusion criteria: * pregnant women

Keywords: bariatric surgery, postoperative pain
lsa reconstruction with laser fenestration during the tevar

Conditions: Type B Aortic Dissection

Summary: this study aims to evaluate the feasibility, effectiveness, and safety of in-situ laser-assisted fenestration on the left subclavian artery during the procedure of thoracic artery endovascular repair

this study is a single-arm, prospective study. all patients with type b aortic dissection (tbad) present with the proximal tear site located approximately close to the left subclavian artery and a reconstruction of the left subclavian artery is necessary are included in the present study. during the procedure of thoracic artery endovascular repair (tevar), the left subclavian artery will be reconstructed with laser-assisted fenestration and the fenestrated stent will be covered stents (fluency, viabhan, lifestream).

Eligibility criteria:
inclusion criteria: * male or non-pregnant female over 18 years of age; * type b aortic dissection; * the left subclavian artery should be reconstructed during the tevar procedure. * patient is willing to provide informed consent and comply with the required follow up visits, testing schedule and medication regimen; exclusion criteria: * life expectancy of \< 5 years; * patients need open surgery repair for the aortic diseases.
correlation of serum level of perampanel (per) level to cerebrospinal fluid (csf) levels of per

Conditions: Epilepsy; Seizures

Summary: perampanel is a drug used to treat patients with epilepsy/seizures. this study is designed to determine how much perampanel actually crosses the blood brain barrier into the cerebral spinal fluid when the drug is taken.

perampanel is a drug used to treat patients with epilepsy/seizures. this study is designed to determine how much perampanel actually crosses the blood brain barrier into the cerebral spinal fluid when the drug is taken. during a routinely scheduled neurosurgical procedure, one to two ml of cerebral spinal fluid will be obtained from the subarachnoid space of the brain. five ml of arterial blood will also be drawn from the patients arterial line during their procedure. the blood samples and cerebral spinal fluid samples will be compared to see how much perampanel is in the blood versus the cerebrospinal fluid.

Eligibility criteria:
inclusion criteria: * adults (\>18 years-old) who are scheduled to undergo brain surgery and need antiepileptic medication for prophylaxis or treatment of seizures * able to provide informed consent exclusion criteria: * patient unable to provide informed consent * allergy to per or its component * patient with significant renal (creatinine clearance 35 ml/min) or hepatic impairment * pregnant or lactating females will be excluded from the study.

Keywords: perampanel
improving tumor oxygenation in cervical cancer

Conditions: Cervical Cancer

Summary: the phenomenon of tumor hypoxia many solid tumors are relatively resistant to treatment with ionizing radiation and certain chemotherapeutic agents such as anthracyclines that are affected adversely by acidic ph. these effects have primarily been attributed to the presence of hypoxic cells within the tumor. the relevance of hypoxia with respect to failure of radiotherapy to cure certain malignancies has had a chequered history. however, in recent years the evidence that hypoxia plays a central role in relative radioresistance has become more compelling. since approximately two-thirds of all women suffering from cervical carcinoma receive radiation as a component of their therapy, an enhanced understanding of the interactions between hypoxia and radiation as a component of their therapy, an enhanced understanding of the interactions between hypoxia and radiation resistance is critical to improving outcome among those with cervical cancer.


Eligibility criteria:
inclusion criteria: * the subject will have a malignant tumor of the cervix which is not curable by surgery in which it has been determined the subject is to receive the standard care of treatment of radiation therapy and chemotherapy. * the subject must have adequate bone marrow function, renal function, hepatic function and neurologic function. * the subject should be free of active infection requiring antibiotics. * the subject must have signed the approved informed consent * if the subject is of childbearing age, they must have a negative urine pregnancy test with effective contraception * the subject must have met pre-entry requirements 1. physical examination to include pelvic examination, blood counts, assessment of liver and kidney status through blood studies 2. a serum pregnancy test 3. detectable tumor will be measured. exclusion criteria: * the subject has not been clinically staged for their cancer * the subject has evidence of or is being treated for an active infection * the subject cannot perform the appropriate follow-up or complete the study for whatever reason. * the subject has not consented to an additional tumor biopsy and mri after my seven days of treatment with methazolamide * the subject has evidence of chronic obstructive pulmonary disease * the subject is currently breastfeeding * the subject is pregnant * the subject takes aspirin chronically * the subject has a history of stevens-johnson syndrome * the subject has not signed the approved informed consent

Keywords: cervical cancer
safety and feasibility of the eyecontrol device

Conditions: ALS (Amyotrophic Lateral Sclerosis)

Summary: the eyecontrol device is an eye movement-based communication device in the form of wearable glasses with connected infrared cam-era that tracks the pupil and translates blinks and movements into commands.this study is aimed to demonstrate the safety and feasibility of the eyecontrol device in healthy volunteers, and als patients in early stages.


Eligibility criteria:
inclusion criteria: 1. subjects 18 to 65 years old 2. subject with understandable speaking communication 3. subject fluent in hebrew (speech and writing skills) additional inclusion criteria for stage 2 of the study: 4. subjects with early stage als diagnosis - whose speech capability is unaffected exclusion criteria: 1. subjects with glasses or contact lenses 2. subjects with eye conditions such as ptosis, strabismus and crossed eyes 3. medical history of epilepsy 4. subjects who according to investigator's judgement, unable to comply with the requirements of this protocol 5. pregnant or lactating women
examination of transcranial focused ultrasound on brain activity in adults

Conditions: Impulsive Behavior

Summary: the investigators aim to examine the immediate effect of transcranial focused ultrasound (tfus) on brain activity in healthy adults.

the investigators will examine ventral striatum (vs) target engagement by tfus in healthy adults using a reward processing task that reliably activates the vs.

Eligibility criteria:
inclusion criteria: * no present/lifetime history of major depressive disorder (mdd), psychosis, bipolar disorder; hamilton depression rating scale (hdrs)\>7; young mania rating scale (ymrs)\>10), borderline personality disorder, and present suicidal ideation * no family history of mdd, psychosis, bipolar disorder, or epilepsy exclusion criteria: * present/lifetime history of mdd, psychosis, bipolar disorder (hdrs\>7; ymrs\>10), borderline personality disorder, and present suicidal ideation. childhood history of, but not present, anxiety disorders and attention-deficit/hyperactivity disorder (adhd) will be allowed as these are common disorders in childhood * family history of mdd, psychosis, bipolar disorder, or epilepsy * history of head injury, neurological (e.g., epilepsy), pervasive developmental disorder (e.g., autism), systemic medical disease and treatment (medical records, participant report) * use of substances with seizure risk (e.g., stimulants) in the past month, as for other non-invasive neuromodulation techniques, assessed as screening and before each tfus session * mini-mental state examination (mmse) score (cognitive state) \<24 * premorbid north american adult reading test (naart) intelligence quotient (iq) estimate \<85; * visual disturbance: \<20/40 (snellen visual acuity) * left/mixed handedness (annett criteria) * history of alcohol or other substance use disorder (sud), daily nicotine use, and/or illicit substance use over the last 3 months (scid-5). note: lifetime/present cannabis use (\<3 times in the past month) at non-sud levels will be allowed, given its common usage in young adults. urine tests on scan days will exclude current illicit substance use. salivary alcohol tests on scan days will exclude intoxicated individuals * binge drinking (as defined by national institute on alcohol abuse and alcoholism (niaa) criteria: consuming 5 or more drinks (male), or 4 or more drinks (female), in about 2 hours.) in the week before, and/or \>3 drinks/day for the 3 days before, and/or alcohol in the last 12 hrs before, any alcohol on tfus scan day, confirmed at screening and scan days. alcohol/nicotine/caffeine/cannabis use (below scid-5 sud and binge levels) will be allowed * mri exclusion criteria: metallic objects, e.g., surgical implants; claustrophobia; positive pregnancy test for females or self-report pregnancy * unable to understand english * taking any psychotropic medications in the past 3 months * any implanted neural device

Keywords: transcranial focused ultrasound magnetic resonance imaging reward