Kornimate/medical-research-clean huggingface dataset:
trial of pde4 inhibition with roflumilast for the management of atopic dermatitis

Conditions: Atopic Dermatitis Eczema

Summary: this is a parallel group, double blind, vehicle-controlled study to assess the safety and efficacy of roflumilast (arq-151) cream vs vehicle applied once daily (qd) for 4 weeks by participants with atopic dermatitis (eczema).


Eligibility criteria:
inclusion criteria: 1. participants legally competent to sign and give informed consent and, if appropriate, assent as required by local laws. 2. males and females, ages 6 years and older at time of signing informed consent (screening). only subjects 18 years and older will be enrolled at sites located in the province of québec in canada. 3. diagnosed with atopic dermatitis 6 months duration (3 months for children), as determined by the investigator. stable disease for the past 4 weeks with no significant flares in atopic dermatitis before screening. 4. females of childbearing potential (focbp) must have a negative serum pregnancy test at screening and a negative urine pregnancy test at baseline/day 1. in addition, sexually active focbp must agree to use at least one form of a highly effective or barrier method of contraception throughout the trial. 5. in good health as judged by the investigator. 6. subjects considered reliable and capable of adhering to the protocol and visit schedule, according to the judgment of the investigator. exclusion criteria: 1. subjects with any serious medical condition or clinically significant abnormality that would prevent study participation or place the subject at significant risk, as judged by the investigator 2. has unstable ad or any consistent requirement for high potency topical steroids. 3. subjects who are unwilling to refrain from prolonged sun exposure and from using a tanning bed or other artificial light emitting devices (leds) for 4 weeks prior to baseline/day 1 and during the study. 4. females who are pregnant, wishing to become pregnant during the study, or are breast-feeding. 5. previous treatment with arq-151. 6. subjects with a history of chronic alcohol or drug abuse within 6 months prior to screening. 7. parent(s)/legal guardian(s) who are unable to communicate, read, or understand the local language(s). subjects who are unable to communicate, read or understand the local language, or who display another condition, which in the investigator's opinion, makes them unsuitable for clinical study participation. 8. subjects who are family members of the clinical study site, clinical study staff, or sponsor, or family members of enrolled subjects living in the same house.
computational assessment of hand motor skills in stroke patients

Conditions: Ischemic Stroke

Summary: this is a two phase prospective observational study that aims to validate the use of a motion capture software (leap motion) to measure and quantify functional deficits of the hand in stroke patients using a standard battery of exercises. the objectives of this study are: 1. to compare the differences between results of hand kinematic computational analysis in patients with ischemic stroke and healthy subjects. 2. to analyze the relation between hand kinematic computational analysis and clinical scales usually performed to evalutate neurologic deficits in stroke patients. 3. to analyze the relation between hand kinematic computational analysis and stroke lesion on brain mri. 4. to analyze changes between results of hand kinematic computational analysis in the acute phase of stroke and at three months, and its relation with evolution of neurological evaluation clinical scales, functional clinical scales and quality of life.


Eligibility criteria:
inclusion criteria: * stroke patients: clinically stable, with hand functional deficit at the momment they consent to participate in the study. signed consent to participate. * healthy subjects: similar age to stroke patients, without previous clinical history of stroke or any disease that could affect hand motor skills. signed consent to participate. exclusion criteria: * aphasia or cognitive impairment, confusional syndrome or other conditions that could prevent comprehension and acomplishment of the task. * plegia or severe paresis of the hand that could prevent adecuate performance of the task. * previous stroke. * previous dependance. * previous diagnosis of any other neurologic disease or condition that could affect hand motricity. * life expectancy below three months.
feasibility of evaluating xstat use in the prehospital setting

Conditions: Shock, Hemorrhagic; Injury Penetrating; Hemorrhage

Summary: this study evaluates the prehospital use of the xstat device to control bleeding in junctional wounds. participants will be randomized to the use of xstat versus standard care.

the xstat® device injects small, rapidly-expanding cellulose sponges into the wound cavity using a syringe-like delivery system. in the wound, xstat® sponges expand and swell to fill the wound cavity, within 20 seconds of contact with blood, facilitating compression of bleeding structures. xstat® can be applied through skin wounds. the system can readily access deep vascular structures. while rapidly hemostatic, the hemostatic sponges are also relatively easy to remove. in the setting of junctional bleeding, xstat® may allow for hemostatic pressure generation from within the wound tract rather than from external compression (as with a tourniquet or manual compression). hemorrhage should be controlled as early as possible, ideally before reaching a trauma center or medical treatment facility. given its small size, low weight, and ease of application, the xstat® device is well-suited for prehospital use, in both the civilian and military setting, and this is probably where the device's applicability lies. the investigators anticipate that a full-scale trial will be conducted based on the questions this pilot study addresses, including the following: 1. the number of penetrating junctional zone injuries encountered in the prehospital civilian setting. 2. the feasibility of randomizing patients in the prehospital setting. 3. usability. 4. safety. 5. validation of the proposed primary outcome of an efficacy trial.

Eligibility criteria:
inclusion criteria: 1. age ≥15 years or estimated body weight ≥50 kg. 2. penetrating junctional injury (femoral or axillary), with i. visible bleeding ii. too proximal to be controlled with a tourniquet 3. patient will be taken to participating level i trauma center, directly from the scene exclusion criteria: 1. prisoners, children \<15 years old, known pregnant patients. 2. patients receiving chest compressions (prior to xstat® use). 3. patients with an opt-out bracelet.

Keywords: hemorrhagic shock hemostatic sponge penetrating injury junctional wounds prehospital
a study to evaluate v181 dengue vaccine in healthy participants 2 to 17 years of age (v181-005/mobilize-1)

Conditions: Healthy

Summary: the purpose of this study is to demonstrate that v181 is safe and well tolerated, elicits an immune response, and reduces the frequency of virologically confirmed dengue (vcd) of any severity, due to any of the 4 dengue serotypes, regardless of dengue serostatus at baseline in children 2 to 17 years of age.

the reactogenicity and immunogenicity subset consists of approximately 3600 participants who will be followed for immunogenicity and safety through 28 days postvaccination. the long-term immunogenicity subset consists of approximately 620 participants randomly selected from the reactogenicity and immunogenicity subset and will evaluate virus reduction neutralization test (vrnt) at designated timepoints up to 5 years postvaccination.

Eligibility criteria:
the key inclusion criteria include but are not limited to: * is generally healthy based on medical history and physical examination. the key exclusion criteria include but are not limited to: * has a known or suspected impairment of immunological function. * has a history of congenital or acquired immunodeficiency. * has a documented human immunodeficiency virus (hiv) infection or is breastfeeding from a mother with documented hiv infection. * has a documented history of hepatitis b or c infection. * has a bleeding disorder contraindicating subcutaneous vaccination or repeated venipuncture. * has a serious or progressive disease, including but not limited to cancer, uncontrolled diabetes, severe cardiac, renal or hepatic insufficiency, or systemic autoimmune or neurologic disorders. * has a known neurologic or cognitive behavioral disorder, including encephalitis/myelitis, acute disseminating encephalomyelitis, pervasive development disorder, and related disorders. * previous receipt of a dengue vaccine or plans to receive any dengue vaccine (investigational or approved) for the duration of the study (other than the study vaccine). * is expected to require systemic corticosteroids ≤28 days after receipt of study intervention. * has received a blood transfusion or blood products, including immunoglobulins, ≤6 months before receipt of study intervention or plans to receive a blood transfusion or blood products (including immunoglobulins) ≤28 days after receipt of study intervention. * has received immunosuppressive therapies, including chemotherapeutic agents used to treat cancer or other conditions, treatments associated with organ or bone marrow transplantation, or autoimmune disease, ≤6 months before receipt of study intervention or plans to receive immunosuppressive therapies ≤28 days after receipt of study intervention.
international spontaneous coronary artery dissection (scad) "iscad" registry

Conditions: Spontaneous Coronary Artery Dissection

Summary: the aim of "iscad," the international spontaneous coronary artery dissection (scad) registry, is to serve as an internationally collaborative, multicenter registry coordinated by an experienced and centralized coordinating center in an effort to increase the pace of participant recruitment, and thereby increase statistical power of studies related to scad. the ultimate goal of iscad registry is to facilitate the development of best practices and clinical guidelines for preventing scad or its recurrence. this observational study will be prospective and retrospective in its recruitment and will collect clinical information to better understand the natural history and prognosis for scad.

spontaneous coronary artery dissection (scad) is an under-diagnosed cause of acute coronary syndrome (acs), myocardial infarction (mi) and sudden cardiac arrest. the inner lining of the coronary artery splits and allows blood to seep into the adjacent layer, forming a blockage (hematoma), or the artery continues to tear, creating a flap of tissue that blocks blood flow in the artery. scad strikes generally healthy, younger individuals (average age 42) who do not have traditional cardiac risk factors. warning signs of scad encompass the full range of acs and mi symptoms, from vague to classic. the cause of scad is currently unknown and the psychosocial impact of scad is traumatizing. the work of the iscad registry will encompass the physical and psychosocial study of scad.

Eligibility criteria:
inclusion criteria: participants with a new diagnosis of scad or a history of confirmed or suspected scad will be prospectively recruited from either: 1. inpatient wards of the enrolling medical centers during the acute presentation of scad, or 2. outpatient cardiovascular clinics of enrolling medical centers. participants must be: * 18 years of age or older * diagnosis of scad or history of scad based on coronary angiography, either catheter-based or coronary cta * suspected scad by coronary angiography exclusion criteria: 1. coronary dissection in association with atherosclerosis or as a result of iatrogenic injury 2. inability to provide informed consent 3. inability to complete study-related patient questionnaires 4. inability to understand and complete patient questionnaires independently

Keywords: spontaneous coronary artery dissection (scad) myocardial infarction sudden cardiac arrest acute coronary syndrome
safety and tolerability of lu ag06474 in healthy young men

Conditions: Healthy

Summary: the purpose of this study is to investigate the safety and tolerability of lu ag06474 and what the body does to lu ag06474 after swallowing single doses of the drug.

part a: randomized, double-blind, sequential. part b: randomized, open-label, cross-over.

Eligibility criteria:
inclusion criteria: * the participant has a body mass index (bmi) ≥18.5 and ≤30 kilograms (kg)/square meter (m\^2) at the screening visit and at the safety baseline/baseline visit. * the participant is, in the opinion of the investigator, generally healthy based on medical history, a physical examination, vital signs, a safety ecg, and the results of the clinical chemistry, haematology, urinalysis, serology, and other laboratory tests. exclusion criteria: * the participant has taken disallowed medication \<1 week prior to the first dose of study drug or \<5 half-lives prior to the screening visit for any medication taken. * the participant has orthostatic hypotension, defined as a decrease in systolic blood pressure ≥20 millimeters of mercury (mmhg) and/or a decrease in diastolic blood pressure ≥10 mmhg from supine to standing, at the screening visit or at the safety baseline/baseline visit. * the participant has a qtcf interval \>450 milliseconds (ms) at the screening visit or at the safety baseline/baseline visit, as calculated by the ecg equipment and evaluated by the investigator. * the participant has taken any investigational medicinal product \<3 months prior to the first dose of study drug. * the participant has received an injection of covid-19 vaccination less than 30 days prior to the first dose of study drug. other inclusion and exclusion criteria may apply.
treatment of negative symptoms and schizophrenia

Conditions: Schizophrenia

Summary: the aim of this study is to evaluate the therapeutic efficacy of a neuromodulation technique, tdcs (transcranial direct current stimulation) used as a complementary treatment on negative symptoms. 60 patients will be randomized into two groups (active tdcs vs sham tdcs) and will be assessed after the intervention, 1 and 3 months after.secondary outcomes shall include neuropsychological assessment, general symptomatology, extrapyramidal symptoms and social functioning.


Eligibility criteria:
* inclusion criteria: * schizophrenia with prominent negative symptoms * exclusion criteria: * other psychiatric or neurological diseases * specific tdcs limitations
randomized controlled trial of internal fixation reconstruction with stent screw in the treatment of kummell's disease

Conditions: BKP; Osteoporotic Vertebral Compression Fracture; Kummell's Disease; Stent-screw-assisted Internal Fixation

Summary: this study is a multicenter, prospective, double-blind, randomized controlled trial using a parallel two-arm design to investigate whether the postoperative 6-month quality of life, vertebral stability, complication of patients with osteoporotic vertebral compression fractures (kummell's disease) are better with the use of stent screw internal fixation and percutaneous bone cement reconstruction technique compared to patients undergoing traditional percutaneous balloon kyphoplasty (bkp) for vertebral augmentation


Eligibility criteria:
inclusion criteria: * age 60 or above, gender not specified. * must have one to three vertebral segments with vertebral compression fracture (vcf) located between t5 and l5, attributed to underlying primary or secondary osteoporosis rather than cancer. * all vcfs must exhibit the following radiographic changes: according to genant's criteria, acute (≤4 months) decrease in anterior, middle, or posterior vertebral height by at least one grade (20-25% reduction in vertebral height, 10-20% reduction in vertebral area) compared to previous x-ray, ct, or mri results. * all vcfs for treatment must occur within four months or less. * all vcfs for treatment must be technically feasible and clinically suitable for bkp or saif surgery. * pre-treatment back pain nrs score must be ≥ 7 and ineffective with conservative (non-surgical) treatment. * pre-treatment oswestry disability index must be ≥ 30 (on a scale of 0-100). * patient's life expectancy must be ≥ 12 months. * must declare willingness to participate in all post-operative follow-ups. * must be capable of understanding the risks and benefits of the study and willing to provide written informed consent. exclusion criteria: * vertebral morphology or fracture morphology unsuitable for balloon kyphoplasty. vcf caused by high-energy trauma. * asymptomatic vcf or vertebral bodies amenable to prophylactic treatment. * vcf at the same site associated with primary bone tumors. * back pain caused by reasons other than acute fractures. vcf with an estimated fracture time of more than 4 months, based on clinical assessment (radiological evidence and patient history). * vcf associated with secondary radiculopathy or neurological compromise. * vcf requiring spinal surgery other than bkp or saif. * spinal cord compression or vertebral canal injury requiring decompression surgery. * combined clinical conditions unsuitable for surgery or affecting subsequent long-term data collection or follow-up. * allergy to any component during the surgical procedure (e.g., bone cement, contrast agents). * concurrent participation in another clinical study. * pregnancy during the study or planning to become pregnant.
the efficacy of transarterial chemoinfusion (tai) combine stereotactic body radiation therapy (sbrt) in unresectable hepatocellular carcinoma (hcc)

Conditions: Hepatocellular Carcinoma

Summary: to evaluate the efiicacy of tai combine sbrt in unresectable hcc


Eligibility criteria:
inclusion criteria: * older than 18 years old and younger than 75 years; * ecog ps≤1; * proven advanced hepatocellular carcinoma according patological examination or easl/aasld diagnostic criteria; * not previous treated for tumor; * cannot accepted hepatectomy; * the lab test could meet: * neutrophil count≥2.0×109/l; * hemoglobin≥100g/l; * platelet count≥75×109/l; * serum albumin≥35g/l; * total bilirubin\<2-times upper limit of normal; * alt\<3-times upper limit of normal; * ast\<3-times upper limit of normal; * serum creatine\<1.5-times upper limit of normal; * pt≤upper limit of normal plus 4 seconds; * inr≤2.2; * sign up consent. exclusion criteria: * cannot tolerate tai or sbrt; * known history of other malignancy; * be allergic to related drugs; * underwent organ transplantation before; * be treated before (interferon included); * known history of hiv infection; * known history of drug or alcohol abuse; * have gi hemorrhage or cardiac/brain vascular events within 30 days; * pregnancy.
comparison of propofol 1mg/kg and propofol 0.5mg/kg for prevention of emergence agitation in children undergoing strabismus surgery during sevoflurane anesthesia

Conditions: Strabismus

Summary: the occurrence of emergence agitation (ea) in pediatric patients who have received sevoflurane anesthesia is a common postoperative problem. among various strategies for reducing the incidence and severity of ea, the use of pharmacological agents at the end of anesthesia is thought to be the most convenient and easily applicable method in clinical situation. the one of typical agents that can be administered in this way is propofol. previous studies demonstrated that the use of propofol 1mg/kg at the end of anesthesia could reduce the incidence of ea with low incidence of postoperative nausea and vomiting. however, it was also demonstrated that the use of propofol 1mg/kg at the end of anesthesia could delay the emergence time. the purpose of this study is to compare the preventive effect on ea and the emergence time between propofol 1mg/kg and propofol 0.5mg/kg administered at the end of sevoflurane anesthesia.


Eligibility criteria:
inclusion criteria: 1. children (3-12 years old) scheduled for elective strabismus surgery undergoing general anesthesia. 2. asa 1-2 exclusion criteria: 1. patients with developmental disability, mental retardation, neurologic disorder, ongoing neurologic medication such as anticonvulsant, previously undergoing general anesthesia, a recent history of upper respiratory infection, parents difficult to read or understand the informed consent.

Keywords: emergence agitation propofol strabismus surgery children elective strabismus surgery
students' understanding and beliefs about pain before and after a one-day pain science education conference: an intervention

Conditions: Pain, Chronic

Summary: the beliefs held by students lead to behaviours in response to their pain which can be both helpful or a hindrance to how they manage their pain. the one-day education event aims to educate the cohort on the contemporary scientific understanding of persistent pain using a mixture of methods. it is hoped this event will result in an improvement in the alignment of beliefs and behaviours to contemporary understanding of persistent pain. the principal aim is to evaluate the pre-post knowledge and beliefs about pain following a one-day pain education event in year 12 students, aged 16 or above.

the students will be asked to complete questionnaires three times relating to their understanding and beliefs relating and intended behaviour in the presence of pain. once at the start of the conference and once at the end, then finally after 3 months. the questionnaire will gather demographic information (age, gender, ethnicity and any history of persistent pain). there will also be a series of multiple-choice questions relating to knowledge and beliefs about persistent pain. the three time points of questionnaire completion will see the students complete the same questionnaire except they will not have to repeat demographic questions. the questionnaire should take 5-10 minutes to complete each time. the questionnaires will be provided online and links will be provided to participants. this is a non-randomised controlled trial and a second school selected as it is part of the same group of schools and equally matched according to the english indices of deprivation 2019. this school will complete the survey at the same time points.

Eligibility criteria:
inclusion criteria: * students at two specified schools in north yorkshire who had been offered the pain study day in year 12 or are in the intervention or control school in year 12 or 13 * aged above 16. * providing consent to participate. exclusion criteria: * students not providing consent.

Keywords: pain knowledge pain beliefs pain behaviour experience of intervention