Kornimate/medical-research-clean huggingface dataset:
effectiveness of nirsevimab in children hospitalised with rsv bronchiolitis

Conditions: Bronchiolitis, Viral

Summary: respiratory tract infections caused by respiratory syncytial virus (rsv) are a worldwide burden and represent a major public health issue. in france, bronchiolitis is responsible for around 100,000 emergency room visits and 50,000 hospital admissions every year; 75% of infants hospitalised for rsv bronchiolitis are healthy full-term children. recent discoveries concerning the specific viral epitopes of rsv have made it possible to move from an empirical approach to a targeted preventive or curative approach (monoclonal antibodies, vaccines, anti-viral drugs). nirsevimab is a monoclonal antibody against rsv with enhanced neutralising activity and a prolonged half-life. a randomised, placebo-controlled phase iii trial demonstrated the effectiveness of nirsevimab in reducing lower respiratory tract infections caused by rsv requiring medical management in healthy premature and term infants, with a favourable safety profile. the us food and drug administration (fda) approved the first rsv vaccine on may 3, 2023, and the second was approved on may 31, 2023. nirsevimab was approved by the european medicines agency (ema) on november 4, 2022.


Eligibility criteria:
inclusion criteria: cases : * children under 12 months of age * treated for acute rsv bronchiolitis * hospitalised following a visit to the paediatric emergency department controls : * children under 12 months * hospitalised in the conventional sector or in a short-stay hospital unit, or having consulted a paediatric emergency department for one of the following reasons * febrile urinary tract infection, without acute ear, nose, and throat (ent) or respiratory symptoms * acute gastroenteritis, without acute ent or respiratory symptoms * infant colic without fever, without ent or acute respiratory symptoms * stagnant weight or feeding difficulties without fever, acute ent or respiratory symptoms * neonatal jaundice without fever or acute ent or respiratory symptoms * unexplained crying without fever, without ent or acute respiratory symptoms * head injury, without acute ent or respiratory symptoms * patient hospitalised for acute surgery without fever, without ent or acute respiratory symptoms exclusion criteria: * refusal to participate by the patient, their relative or legal representative * administration of palivizumab. * maternal vaccination against rsv.
steps: stepped transition in education program for students with asd

Conditions: Autism Spectrum Disorder

Summary: young adults who have autism spectrum disorder (asd) without co-occurring intellectual impairment face a fairly unique set of challenges as they transition out of secondary school. these students are often quite capable of succeeding in higher education and many of them have interest in pursuing advanced degrees, but the nature of their disability and associated deficits (e.g., poor time management and poor self-regulation) may impede success. individualized, appropriately timed, and developmentally sensitive transition and support services may promote optimal outcomes for these young people. the goal of this project is to develop a comprehensive program to promote successful transition of students with asd from high school to post-secondary education.

the investigators propose to refine and then evaluate a novel transition support and intervention program for adolescents and young adults with asd: steps \[stepped transition in education program for students with asd\]. by targeting improved self-regulation (sr) and self-determination (sd) in young people with asd, the investigators assert that this program may have positive outcomes with respective to college adjustment and functional behavior. although the program will be finalized during the first phase of the proposed project, at present steps is comprised of two levels (or steps), which match the student's particular needs in relation to transition planning. in step 1, students facing transition (i.e., have identified the college they will attend (either 2-year or 4-year institution) but are still in high school) and their caregivers will receive information to assist in transition planning, undergo readiness self-assessments (to identify degree of preparedness for post-secondary school), and participate in interactive sessions online and in person to promote self-knowledge and determination. the goal of step 1 is to assist families and students with transition planning, specifically ensuring that families and students have the tools needed to make informed choices and take necessary steps (e.g., remediating identified skill deficits) to increase the likelihood of a successful transition out of high school. in step 2, college students with asd will receive fairly intensive supports and interventions, including individual counseling, structured support services, social integration activities, and coaching to promote academic and social success. the following specific aims are proposed.

Eligibility criteria:
inclusion criteria: * must be 16 to 25 years * must have clinical diagnosis of autism spectrum disorder * must be preparing for postsecondary education or enrolled in postsecondary education exclusion criteria: * intellectual disability * psychiatric disturbance that warrants immediate treatment

Keywords: structured transition support program transition 'as usual'
comprehensive diagnosis and treatment strategy for opportunistic fungal infections in aids patients

Conditions: Opportunistic Fungal Infections

Summary: opportunistic fungal infection is the most common opportunistic infection in aids patients, with the high mortality and recurrence rate due to the lack of standardized comprehensive diagnosis and treatment strategy. this project aims to combine traditional detection and observation indicators with molecular biology, serology and mass spectrometry identification technology to develop early screening and diagnostic strategies for opportunistic fungal infections in aids patients, explore scientific evaluation methods for anti-fungal efficacy and formulate comprehensive strategies for reducing the mortality and recurrence rate.

the research involves aids patients complicated with talaromycosis, pcp and cryptococcosis in the study. the main contents: 1. to explore early screening and diagnostic strategies. to advance the application of taloromyces marneffeispecific mannose protein (mp1p), (1,3)- β- d-glucan (g antigen) and cryptococcus capsular antigen (crag) serological detection, qpcr, dd- pcr and mass spectrometry identification in clinical practice. 2. to develop scientific evaluation strategy of anti-fungal treatment effect. on the basis of routine clinical, laboratory, imaging indexes and qfc, qpcr, dd-pcr and serological quantitative detection methods were combined to explore strategies for evaluating anti-fungal efficacy. 3 .to determine the termination timing of secondary prevention to explore the scientific timing to terminate secondary prevention after art, combing cd4 + t cell count with plasma hiv rna, hiv dna of peripheral blood mononuclear cells (pbmc), cd4 + / cd8+ ratio and chronic immune activation index

Eligibility criteria:
inclusion criteria: 1. age (16-70 years), male and female; 2. hiv-1 infected; 3. hospitalized patients with the signs or symptoms inferred to infection; 4. initial cd4 cell count less than 200 cells/ul; hiv-1 rna viral load was unlimited; 5. state informed consent for free treatment has been signed; 6. good compliance and signing informed consent exclusion criteria: 1. have been treated regularly in other hospitals or have been clearly diagnosed before admission; 2. researchers decide if patients could/not complete the scheduled follow-up (factors to consider such as weak, poor compliance, etc.); 3. pregnancy during the study period; 4. hospital stay less than 7 days.

Keywords: talaromycosis pneumocystis pneumonia cryptococcus infection
efficacy and safety of acetaminophen and aspirin versus placebo in the acute treatment of migraine

Conditions: Acute Migraine

Summary: the purpose of the study is to evaluate the efficacy and safety of acetaminophen and aspirin versus placebo in the acute treatment of migraine


Eligibility criteria:
inclusion criteria: 1. male or female aged 18 years and over. 2. international headache society (ihs) diagnosis of migraine without aura or typical aura with migraine headache. 3. history of experiencing at least 1, but not more than 8, acute migraine attacks monthly during the previous year. 4. history of at least moderate migraine pain intensity, if left untreated. 5. history of frequently or always experiencing nausea with the migraine attack. exclusion criteria: subjects eligible for inclusion in this study must not fulfill any of the following criteria: 1. headache symptoms which may be due to or aggravated by: * recent (within 6 months) head or neck trauma (e.g., whiplash) * head or neck pain secondary to an orthopedic abnormality * cluster headache * specific migraine variants (e.g., basilar-type artery migraine, opthalmoplegic migraine, hemiplegic migraine, migraine aura without headache) * other serious, non-migraine causes of headache (e.g., increased intracranial pressure, intracranial bleeding, meningitis, malignancy) * non-serious, non-migraine causes of headache (e.g., cold, flu, hangover) 2. history of vomiting during more than 20% of migraine attacks. other protocol-defined inclusion/exclusion criteria may apply

Keywords: migraine acetaminophen aspirin
therapeutic approach of cardiovascular risk factors in t2dm by gender

Conditions: Type 2 Diabetes; Cardiovascular Risk Factor; Gender

Summary: background: patients with type 2 diabetes mellitus (t2dm) are at 2- to 4-fold higher risk of cardiovascular mortality compared with non-diabetic subjects. cardiovascular disease (cvd) is the main cause of death in almost half of diabetic population in spain. female patients with t2dm have up to 40% excess risk of cvd compared with men and the causes are still unknown. it is argued that a tight control of cardiovascular risk factors could improve the situation. hypothesis: the cardiovascular risk factors management in women with t2dm is different than in men with t2dm. aims: to assess the therapeutic approach of cardiovascular risk factors and the occurrence of cardiovascular events among women in comparison to men with t2dm. methodology: observational study based on clinical records of primary health care from t2dm patients in catalonia (2007-2013). source: sidiap database. analysis: the two study groups (women and men) will be matched to ensure balance in terms of basal comorbidities and previous cardiovascular disease in order to describe the study group characteristics and to perform a multivariate modeling approach. applicability and relevance: this study is intended to serve to identify the points of improvement of the cardiovascular risk factors therapeutic approach in women.


Eligibility criteria:
inclusion criteria: * female and male patients \> 30 years of age with a clinical record in the sidiap database. * patients with a diagnosis of type 2 diabetes (codes icd10: e11, e11.0-e11.9, e14, e14.0-e14.9) on dtall-30jun of each year exclusion criteria: - patients with a diagnosis of type 1 diabetes (e10), gestational diabetes (o24), secondary diabetes (e12) or any other type of diabetes (e13)
porphyromonas gingivalis and alzheimer's disease

Conditions: Alzheimer's Disease; Dementia; Periodontitis

Summary: with this study the investigators would like to analyze the the role of periodontal disease and especially the role of porphyromonas gingivalis in initiation and progression of alzheimer's disease.


Eligibility criteria:
inclusion criteria: * age 40-70 * caucasian origin * dementia (alzheimer's or other dementia) * cognitive healthy (need for spinal anesthesia) exclusion criteria: * use of antibiotics within las 6 months * pregnancy * another illness explaining the symptoms in a better way * smoking (\>10 cigarettes) * patients who have a legal custodian
physiology, imaging and modeling of essential tremor

Conditions: Essential Tremor; Parkinson Disease; Dystonia

Summary: this project aims to investigate novel ways to deliver brain stimulation to essential tremor (et) patients by introducing software changes to their existing devices. the study team aims to investigate safety and efficacy of these new stimulation parameters in patients with et.

deep brain stimulation (dbs) is a neuromodulatory therapy that is effective in a subset of well selected essential tremor (et) patients. however, as many as 1/5 of patients may initially improve, but then steadily worsen following the operation. the investigators developed a technique to study a variety of alternative stimulation methods without the use of an invasive repeat surgical intervention. the electrophysiological effects of non-conventional dbs differ from traditional dbs, however the physiological differences in the setting of human tremor remain largely unknown. this study plans to explore gaps in knowledge of neuromodulation and will collect and contribute essential information to the underlying mechanism of action of dbs. the hypothesis of this project centers around active biphasic stimulation providing a wider therapeutic window and a lower adverse event profile as compared to conventional dbs.

Eligibility criteria:
inclusion criteria: * existing unilateral or bilateral vin dbs for et, non-demented (mmse\>24), and must have a documented suboptimal tremor suppression on two successive visits (compared to the baseline post-operative improvement at 6 months following et dbs surgery). for bilateral cases, the most affected tremor side will be studied. exclusion criteria: * no diagnosis of essential tremor

Keywords: deep brain stimulation (dbs) ventralis intermedius nucleus (vin) implantable pulse generator (ipg) diffusion tensor imaging (dti)
study of blu-808 in chronic inducible urticaria (cindu) and chronic spontaneous urticaria (csu)

Conditions: Chronic Inducible Urticaria; Chronic Spontaneous Urticaria

Summary: this is a 2-part, proof-of-concept study to be conducted globally, designed to evaluate the safety, tolerability, clinical activity, pharmacokinetics, and pharmacodynamics of blu-808, a wild type kit inhibitor, in participants with cindu (part a) or csu (part b).


Eligibility criteria:
key inclusion criteria: * part a: confirmed diagnosis of cindu for ≥3 months prior to day 1 that is inadequately controlled with second generation h1-antihistamines. * part b: confirmed diagnosis of csu for ≥6 months prior to day 1 that is inadequately controlled with second generation h1-antihistamines. key exclusion criteria: * part a: any active urticaria that may interfere with study assessments. * part a: history of cold-induced anaphylaxis. * part b: participant has a clearly defined predominant cause of chronic urticaria or sole trigger such as symptomatic dermographism and cold-induced urticaria. * part a and part b: any other skin disease associated with chronic itching or angioedema that might influence the study evaluations and results, skin diseases associated with only wheals and no itch, or autoinflammatory diseases with urticarial lesions. * part a and part b: significant medical, psychiatric, or surgical conditions, or physical findings that may affect participant safety, study drug metabolism, study participation, or assessment of study results. * part a and part b: abnormal laboratory values that may pose risks or interfere with study participation. * part a and part b: pregnancy or plans for pregnancy; breastfeeding.

Keywords: chronic inducible urticaria chronic spontaneous urticaria blu-808 cindu csu chronic urticaria cu cold urticaria coldu symptomatic dermographism sd
retinal imaging & ambulatory blood pressure

Conditions: Hypertension; Blood Pressure

Summary: high blood pressure is a common condition which generally does not have any symptoms. its estimated that around one third of people with high blood pressure do not know they have it. the back of the eye called the retina is one of the few places in the human body allowing easy observation of blood vessels. this study aims to see if simple non-invasive imaging of the blood vessels of the retina will highlight people with high blood pressure.

this will be a prospective, single centre study recruiting patients who are attending the ambulatory blood pressure clinic at the western general hospital. suitable patients will be approached, and if they consent will have pictures of the back of each of their eyes taken. these pictures will then be reviewed, with certain measurements taken of the small blood vessels which can been seen at the back of the eye. these measurements will then be compared to the participants blood pressure readings to see if they might accurately correlate to blood pressure.

Eligibility criteria:
inclusion criteria: * attending ambulatory blood pressure clinic * able to undertake ambulatory bp measurement * able to undertake single clinic-based bp measurement * able to undergo uwf retinal imaging with a slo * aged 18 to 90 * able to give informed consent exclusion criteria: * people with known history of retinal surgery * people under the age of 18 years. * people that cannot: manoeuvre themselves to the slo unaided, sit upright in a chair or wheelchair or position themselves comfortably for imaging. * people with epilepsy
does restriction of the dominant hand due to injury improve non-dominant hand function?

Conditions: Dexterity; Tendon Injuries; Fractures; Nerve Injury

Summary: hand injuries result in the restriction of use of the injured hand within a splint or a plaster during the first 6 weeks which is critical for tissue healing. when the dominant hand is injured, patients experience more difficulty in daily life due to this restriction. patients injured on their dominant hand mostly express that they are forced to use their non-dominant hand in their activities and as a result, the function of the non-dominant hand improves. however, the non-dominant hand function has not been analyzed in patients with restricted use of the dominant hand during the tissue healing period.


Eligibility criteria:
inclusion criteria: * individuals who need to use a splint for 6 weeks due to any pathology in their dominant hand * ages between 18-65 * individuals who are within the first 10 days after the operation exclusion criteria: * individuals with an isolated thumb injury * those who require bilateral use of the splint/have bilateral pathology * those who have a condition that prevents the use of the non-dominant hand * those who can use both hands equally/do not have a dominant side (ambidextrous/two-handed) * those who have a cooperative status that will not comply with the treatment program * data from individuals who do not use the splint as described during the 6-week follow-up period will not be included in the analysis.
therapeutic effect of tacrolimus on primary nephrotic syndrome in children

Conditions: Nephrotic Syndrome

Summary: to determine the efficacy of tacrolimus in the management of ns(nephrotic syndrome) , the investigators designed this prospective study. the investigators will enroll 100 children with ns(frequent relapse steroid dependent ns, steroid resistance ns) who will be treated with tacrolimus (0.1-0.2 mg/kg/day in two divided doses over 12 h adjusted to a trough level between 5 and 10 ng/ml) for 12 months in combination with low-dose steroids. other therapies will be included angiotensin-converting enzyme inhibitors, antihypertensive drugs, multivitamins and lipid-lowering agents. follow-up is every second week for the first 4 weeks, then monthly. after initiation of tacrolimus therapy, blood was drawn each visit to determine tacrolimus trough levels.

subsequently , monthly measurements were made until stable levels of tacrolimus were achieved. urine was analyzed for proteinuria at each visit. serum creatinine, glucose, albumin and alanine aminotransferase were measured and complete blood counts were obtained at each visit during the study.

Eligibility criteria:
inclusion criteria: * frequent relapse nephrotic syndrome * steroid resistance nephrotic syndrome exclusion criteria: * secondary nephrotic syndrome * estimated glomerular filtration rate \< 60 ml/min/1.73m2 * with active hepatitis

Keywords: primary nephrotic syndrome
caprini score in venous surgery: a prospective cohort study

Conditions: Venous Thromboembolism; Varicose Veins

Summary: the aim of the study is to make a validation of caprini score in patients undergoing varicose veins surgery, especially endovascular procedures (endovascular laser treatment - evlt, radiofrequency ablation - rfa, ultrasound-guided foam sclerotherapy - usfs) and to identify patients with elevated risk of postoperative venous thromboembolism (vte) who will benefit from prophylactic anticoagulation.

a prospective cohort study based on the platform of ongoing registry of treatment of chronic venous diseases (nct03035747). the study will enrol adult patients undergoing any kind of varicose veins surgery with and without any prophylaxis. the patients should be examined for venous thromboembolic complications during 2-4 weeks after the procedure with mandatory duplex ultrasound. the study will provide following information: * the rate of asymptomatic dvt after varicose veins surgery * the rate of symptomatic vte after varicose veins surgery * the rate of thermal-induced thrombosis (ehit) after endovenous thermal ablation * the ability of caprini scores to predict vte after varicose veins surgery * identification of patients with high risk of vte who will benefit from prophylaxis, especially with anticoagulation

Eligibility criteria:
inclusion criteria: * age over 18 years * any kind of varicose vein surgery * follow up for 4 weeks after the procedure * examination for vte at 2-4 weeks after the procedure, including duplex ultrasound exclusion criteria: - lost for follow-up during 4 weeks

Keywords: venous thromboembolism deep vein thrombosis pulmonary embolism varicose veins surgery endovenous laser treatment radiofrequency ablation ultrasound-guided foam sclerotherapy register anticoagulation
drug eluting balloon in peripheral intervention for below the knee angioplasty evaluation

Conditions: Critical Limb Ischemia

Summary: drug-eluting balloon showed positive results in terms of restenosis reduction in peripheral intervention (pta). the aim of the study is to investigate in a randomized fashion the efficacy and safety of paclitaxel-eluting balloon (peb) (in.pact amphirion, invatec, brescia, italy) versus non drug-eluting balloon (neb) (amphirion deep, invatec, brescia, italy) in diabetic patients with critical limb ischemia (cli) undergoing pta of below-the-knee (btk) vessels.


Eligibility criteria:
inclusion criteria: * age\>18 years * angiographic stenosis\>50% or occlusion of one below-knee vessel exclusion criteria: * allergy to paclitaxel * contraindication for combined antiplatelet treatment * life expectancy \<1 year * hypersensitivity or contraindication to one of the study drugs * lack of consent * need for amputation

Keywords: critical limb ischemia drug-eluting balloon restenosis