Kornimate/medical-research-clean huggingface dataset:
impact of helminth infections during pregnancy on humoral vaccine immunogenicity in infants

Conditions: Maternal Infection Affecting Newborn

Summary: helminth infection is associated with low vaccine immunogenicity. pregnant women are particularly sensitive to helminth infection. since most vaccines are given shortly after birth, an effect of parasites on infant immunogenicity is of particular concern. therefore, within this study the investigators aim to investigate if maternal infection influences vaccine immunogenicity in the newborn.

there is evidence that helminth infections during pregnancy affect the immune system of the mother and the unborn child. as a consequence, the antimicrobial- immune and vaccine- response of the infant may be deficient. the aim of the present study is to measure the influence of maternal helminth infection (schistosomal, filarial and intestinal helminth infection) on vaccine immunogenicity of their infants. the main focus is on immune responses of infants to vaccine antigens given as part of the expanded program on immunization (epi) in gabon at an age when infants are unlikely to be infected with helminths and are immunologically primed by their intrauterine life. the objective is to investigate if and which species of helminths during pregnancy have an effect on any of the epi vaccine-induced immune responses.

Eligibility criteria:
inclusion criteria: * signed informed consent form (icf) by the participant aged 18 years or older or by a legal major representative and the participant * willingness to deliver in one of the two maternities in the study area * willingness and ability to comply with study protocol for the duration of the trial * willingness to give blood for the examinations and to provide samples for helminth assessment (stool, urine, blood) exclusion criteria: * known chronic diseases (diabetes, tb, hiv, hcv or hbv infection); these will be assessed on a regular basis at given examinations during pregnancy * withdrawal of consent * poor general health (including a hemoglobin level out of local reference range) * signs of symptoms of helminth infection which needs immediate treatment of the mother * planned migration from the area

Keywords: helminth infection vaccination
efficacy and safety of iglarlixi versus insulin glargine plus dulaglutide in patients with type 2 diabetes

Conditions: Type 2 Diabetes Mellitus; Glucose, High Blood

Summary: the investigators aimed to compare efficacy and safety of iglarlixi and insulin glargine plus dulaglutide as intensification from basal insulin with metformin, in the absence of head-to-head trials.

fixed-dose combinations of insulin glargine/lixisenatide (iglarlixi) or insulin glargine plus dulaglutide constitute treatment intensification in type 2 diabetes mellitus (t2d). the investigators aimed to compare efficacy and safety of iglarlixi and insulin glargine plus dulaglutide as intensification from basal insulin with metformin, in the absence of head-to-head trials. treatments were compared in terms of glycated hemoglobin (hba1c), fasting plasma glucose (fpg) change from baseline, and variables from continuous glucose monitoring (cgm) system; in addition to safety issues on hypoglycemia and changes in weight.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years old * patient with type 2 diabetes, treated with basal insulin plus metformin (maximum tolerated dosage) for at least 12 weeks * patient accepting to participant to this study exclusion criteria: * pregnant or breastfeeding woman * severe renal dysfunction (egfr \<60 ml/min/1.73m2) * chronic or acute hepatic disorder (hbv or hcv hepatitis, liver cirrhosis etc.) (ast/alt \> 2.5\*uln) * prescription such as immunosuppressant agents, glucocorticoids * active anti-cancer treatment

Keywords: iglarlixi dulaglutide continuous glucose monitoring system type 2 diabetes mellitus
fourier transformed infrared spectroscopy in macular surgery

Conditions: Epiretinal Membrane; Macular Hole

Summary: epiretinal membranes (erm) are disorders leading to vision loss and metamorphopsia. vitrectomy with membrane peeling has developed to be the gold-standard in treatment of erm. erm can be well visualized with spectral domain optical coherence tomography (sd-oct). the aim of the study is to examine erm and internal limiting membranes (ilm) exzised during routine macular surgery with fourier transformed infrared spectroscopy (ftir) and compare results to optic coherence tomography (oct) findings.

purpose of the present study is to analyse components of erm and ilm, giving hints for the origin of cells producing erm. in contrast to electron microscopy, ftir spectroscopy does not need any chemical fixation of the membranes and therefore structure of components of erm and ilm are not changed by fixation. in total, 20 eyes with idiopathic erm, 10 eyes with lamellar macular hole, 10 eyes with full thickness macular hole and 10 eyes with diabetic erm will be examined. to our knowledge there are no previous reports about ftir spectroscopy of erm and ilm, therefore the study will be performed as an exploratory pilot study.

Eligibility criteria:
inclusion criteria: * idiopathic erm, lamellar macular holes, full thickness macular holes, diabetic erm and the indication for surgery (visual symptoms) * age 21 and older * written informed consent for surgery and participation in the study prior to surgery exclusion criteria: - macular edema due to other reasons than erm * hereditary macular disorders * in case of pregnancy (pregnancy test will be taken preoperatively in women of reproductive age)
comparison of two different techniques of synovial biopsy and resistances of cutaneous smears in suspected ppi

Conditions: Infection of Total Knee Joint Prosthesis

Summary: the purpose of this study is to determine whether an undirected synovial biopsy technique has the same accuracy in detecting periprosthetic joint infection in the knee as an arthroscopic assisted directed synovial biopsy technique.

successful treatment of an infected joint arthroplasty depends on correctly identifying the responsible pathogens. the value of a preoperative biopsy remains controversial. we compared the sensitivity and specificity of two techniques of synovial biopsy of knee joint arthroplasties suspicious for infection and asked whether the results correlate with intraoperative findings at revision.

Eligibility criteria:
inclusion criteria: * chronic painful knee prosthesis planned for synovial biopsy to detect infection * culture-negative joint aspiration exclusion criteria: * co-morbidities: tumour disease, immune suppression

Keywords: synovial biopsy knee arthroplasty infection
program of evaluation and geriatric intervention on the functional status, quality of the life, and survival

Conditions: Acute Myeloid Leukemia

Summary: acute myeloid leukaemia (aml) is a disease of the elderly, with a median age at diagnosis of 65. a poor outcome in this population has been well established, with very short overall survival (os) and disease free survival (dfs).there are numerous bad prognostic factors related to the disease itself or to the patient's medical condition. this study will evaluate the impact of a comprehensive geriatric assessment (cga) performed at diagnosis with planned interventions according to disabilities and monthly follow-up by a nurse practitioner during 6 months on functional status of older cancer patients treated for acute myeloid leukaemia. functional status will be assessed with the lawson instrumental activities of daily living (iadl) scale at diagnosis and 6 months after randomisation.


Eligibility criteria:
inclusion criteria: * patients aged 70 years and older * referred for treatment following a diagnosis of acute myeloid leukaemia. * signed informed consent exclusion criteria: * terminal patients, with a life expectancy estimated to be less than 3 months, will be excluded from the study, due to ethical issues and the fact that they are unlikely to benefit from this evaluation. * patients unable to give informed consent.

Keywords: acute myeloid leukemia
clinical study to investigate the safety, tolerability, and pharmacokinetics of gr1603 in sle

Conditions: Lupus Erythematosus, Systemic

Summary: a study to investigate the tolerability, safety,pharmacokinetics and efficacy of gr1603 in subjects with systemic lupus erythematosus ； gr1603 injection is a monoclonal antibody targeting ifnar1, which can block ifnar binding to type i interferons such as ifnα and be used to treat systemic lupus erythematosus.

this is a phase ib/ⅱ,double blind, multiple-dose study to evaluate the pharmacokinetics (pk), safety，tolerability and efficacy of intravenously administered gr1603 in participants with active sle despite receiving standard of care . phase ib is a multi-dose escalation phase in which 16 subjects are scheduled to enroll. a total of 120 subjects were randomly assigned to gr1603 injection low dose group, high dose group or placebo group in phase ⅱ.

Eligibility criteria:
inclusion criteria: * diagnosis of sle according to the acr 1997 ≥24 weeks * active moderate to severe sle * at least one of these antibodies positive: ana, anti-dsdna and anti-smith. exclusion criteria: * active severe or unstable neuropsychiatric sle * clinically significant laboratory test * clinically significant active infection

Keywords: ifnr autoimmune diseases sle
clinical evidence of ph dependent ß2 adrenergic transport mechanisms in the airway

Conditions: Healthy Volunteers

Summary: the purpose of this study was to determine if airway ph has an effect on albuterol-induced vasodilation in the airway. methods: ten healthy volunteers performed the following respiratory maneuvers: quiet breathing, hypocapnic hyperventilation, hypercapnic hyperventilation, and eucapnic hyperventilation

the lungs provide a unique absorptive surface for drug delivery. many inhaled drugs are rapidly absorbed into the airway because of their lipophilic chemical characteristics. however, the majority of the currently used β2-adrenergic bronchodilators cannot freely diffuse across the epithelial cell membrane because of their transient or permanent positive charge at physiological ph. inhaled albuterol, a β2-adrenergic agonist used widely for the treatment of obstructive airway disease, is charged positively in neutral or acidic conditions and thus requires active transport across the airway epithelium. previous studies in the lab have shown that albuterol uptake into airway epithelia occurs via a ph sensitive cation transporter (octn2). the vasodilator response to an inhaled β2-adrenergic agonist could be an expression of epithelial cation transport. the investigators propose that the magnitude and duration of vasodilation in the airway caused by an inhaled hydrophilic β2-adrenergic agonist such as albuterol may be altered by changes in airway ph. the purpose of this protocol is to determine the effect of asl ph on the response of qaw to inhaled albuterol by manipulating airway ph through ventilatory maneuvers in health subjects: hyperventilation to raise ph and ventilation with co2 bleed-in to lower ph.

Eligibility criteria:
inclusion criteria: * lifetime non-smokers * fev1 \> 80% predicted value and fev1/fvc \> 0.75 exclusion criteria: * cardiovascular disease or use of cardiovascular or vasoactive drugs; * lung disease or use of airway drugs (i.e. inhaled corticosteroids, β adrenergic agonists); * respiratory infection during the 4 weeks preceding the study * use of systemic glucocorticoids within 4 weeks of the study * pregnant or nursing females

Keywords: airway blood flow albuterol acidosis alkalosis
operative treatment of traumatic anteroinferior shoulder instability in young male patients

Conditions: Shoulder Instability

Summary: glenohumeral joint is prone to instability, i.e. the humeral head may dislocate off the scapular glenoid plate especially in the anteroinferior direction. surgical treatment of shoulder instability aims at restoration of shoulder stability. the purpose of this trial is to investigate the difference in outcome after arthroscopic bankart operation compared with open latarjet operation in the treatment of a residual instability after a traumatic primary dislocation in young males.


Eligibility criteria:
inclusion criteria: 1. subluxation or fear of shoulder dislocation after a previous, reduced and primarily conservatively treated (for more than 3 months) traumatic anteroinferior shoulder dislocation, or redislocation after a primary shoulder dislocation. 2. clinically documented anteroinferior instability (ie. a positive apprehension and relocation test (jobe)). 3. x-ray (true ap, 30 degrees oblique ap, y- and axillary projections), 2- and 3-dimensional computed tomography (2d and 3d ct) and magnetic resonance imaging arthrography (mra) documentation of the joint. 4. congruency of the shoulder joint on imaging investigations. 5. young adult male patient 16-25 years of age (15 years \< patient \< 26 years ). 6. patient's willingness for operative treatment. 7. written informed consent from participating subject. exclusion criteria: 1. non-congruency of the glenohumeral joint on imaging investigations. 2. concomitant dislocated fractures (requiring operative treatment) of the humerus or the scapula (other than hill-sachs lesion or bony bankart lesion) 3. severe grade 2 or above (samilson et prieto) osteoarthrosis of the glenohumeral joint detected in x-ray investigation. 4. a humeral avulsion of glenohumeral ligaments (hagl) detected in mra investigation. 5. concomitant ipsilateral plexus or axillar nerve injury affecting motor function. 6. life threatening other concomitant injuries (i.e. multitrauma patient). 7. stiffness of the glenohumeral joint (restricted passive external rotation less than 30 degrees measured in standing position, arm at side). 8. age under 16 or above 25 years. 9. open physis with significant growth expectation. 10. intellectual disability, history of seizures with high risk of recurrence, existing significant malignant, haematological, endocrine, metabolic, or rheumatoid disease.

Keywords: surgical treatment bankart latarjet redislocation
intra-arterial chemotherapy for advanced intraocular retinoblastoma

Conditions: Retinoblastoma; Eye Cancer

Summary: phase ii study of selective intra-arterial infusion of chemotherapy for intraocular retinoblastoma


Eligibility criteria:
inclusion criteria: 1. patients diagnosed with advanced intraocular retinoblastoma (international retinoblastoma classification group d or e\*). 2. patients with tumor recurrence or vitreous seeding following completion of systemic chemotherapy or previous radiation therapy. exclusion criteria: 1. congenital brain anomaly identified on mri. 2. history of systemic coagulopathy. 3. evidence of extra ocular retinoblastoma on clinical examination or neuroimaging.
effect of precise grip strength training on picc catheter-related thrombosis in cancer patients

Conditions: Lung Cancer; Stomach Cancer; Breast Cancer; Liver Cancer; Colon Cancer; Rectal Cancer

Summary: in this study, color doppler ultrasound diagnostic instrument and electronic grip device were used to determine the best grip strength of patients with tumor picc catheterization, formulate precise and standardized grip strength training guidance for them, provide personalized functional exercise health education, and observe the impact of precise grip strength training guidance on peripheral central venous catheter-associated thrombosis. to provide a reference for clinical prevention of peripheral central venous catheter-associated thrombosis in the future.


Eligibility criteria:
inclusion criteria: * cancer patients undergoing chemotherapy throughout their treatment in our hospital * patients with picc implanted for the first time and maintained at our hospital; * age 18-60 years; * normal cognitive function; * the clenching movement is barrier-free; * the material and performance of picc catheter are silicone three-way valve catheter; * catheter placement under the guidance of portable color doppler ultrasound diagnostic instrument; * voluntarily participate and sign the informed consent form. exclusion criteria: * patients treated with combined radiotherapy; * patients with coagulation dysfunction; * patients who need to use anticoagulant drugs due to underlying diseases; * puncture times more than 1 time; * the blood flow velocity of catheterization vessel in calm state was less than 4.78cm/s.

Keywords: picc；cancer patients；grip strength training
capivasertib regulatory postmarketing surveillance in korea

Conditions: Breast Cancer

Summary: to fulfil the post-approval commitment of mfds to conduct post-marketing surveillance, this study is designed to assess the known safety profile, identify previously unsuspected adverse reactions and to evaluate the effectiveness of capivasertib under conditions of routine daily medical practice in korea.

the objectives of this study are to assess the safety and effectiveness of capivasertib (hereinafter "the study drug") in a real-world practice setting for patients prescribed with the study drug under the approved local label in south korea. primary objective to assess the safety of the study drug in patients prescribed with the study drug under the approved label(s) in south korea secondary objective to assess effectiveness of the study drug in patients prescribed with the study drug under the approved label(s) in south korea

Eligibility criteria:
inclusion criteria: * patients eligible for and treated with the study drug according to the approved label in south korea * patients who provide signed and dated written informed consent, either personally or through a legally acceptable representative. exclusion criteria: * participation in any interventional trial during the treatment of the study drug * other off-label indications according to the approved label in south korea
conditional imaging prescription strategy for exploration of acute uncomplicated renal colic

Conditions: Acute Renal Colic; Nephrolithiasis

Summary: prospective single centre study aiming at validating a conditional imaging strategy for diagnosis of suspected kidney stone. consecutive emergency department patients referred to the medical imaging department for exploration of a suspected acute uncomplicated renal colic will undergo the following interventions : systematic plain abdominal xray, systematic ultrasonography and systematic unenhanced ct (with a reduced dose scan), in addition to clinical examination and assessment of body mass index and the sex, timing, origin, nausea, erythrocytes (stone) clinical prediction score for symptomatic stone. patients will be followed up at 1 month to record the need for urologic intervention and its type. the performances of different conditional imaging strategy for the diagnosis of suspected renal colic will be assessed retrospectively. the conditional strategies tested will be based on the patient's stone score and bmi and targeted use of combined plain x-ray and ultrasonography and/or unenhanced ct. the reference diagnosis for renal colic will be made according to the finding of a ureteral stone or indirect signs of urolithiasis at unenhanced ct.

plain abdominal xray, ultrasonography and unenhanced ct of the abdomen and pelvis will be performed at the time of admission to the imaging department, within 2 days from ed visit and within a 1 hour delay from each other. ultrasonography will be interpretated in combination to plain abdominal xray, and independently from unenhanced ct, by two experienced radiologists blinded to the results of each other.

Eligibility criteria:
inclusion criteria: * adult patient * patient admitted to the emergency department with suspected acute uncomplicated renal colic exclusion criteria: * patient presenting with fever (\>38°c) * patient with persisting pain despite administration of morphinic * patient presenting with anuria * patients with a single kidney and/or history of chronic renal failure * pregnant women or breastfeeding women * patient with a history of renal colic * patients unable to provide informed consent

Keywords: nephrolithiasis ureteral stone acute renal colic ultrasonography computed tomography diagnosis
bioequivalence of two insulin aspart formulations (100 u/ml versus 200 u/ml)

Conditions: Diabetes; Healthy

Summary: this trial is conducted in europe. the aim of this trial is to test if there is bioequivalence between the insulin aspart 100 u/ml (u100) formulation and the new insulin aspart 200 u/ml (u200) formulation.


Eligibility criteria:
inclusion criteria: * considered to be healthy as judged from vital signs, medical history, ecg (electrocardiogram), laboratory values, and physical examination * body mass index between 18 and 27 kg/m\^2 (both inclusive) * non-smoker * fasting blood glucose maximum 6 mmol/l * hba1c below 6.4% exclusion criteria: * pregnant or breast-feeding women * women not using acceptable methods of contraception without difficulties for at least three months prior to trial start (screening), including intrauterine devices, oral contraceptives, hormonal implants, or sterilisation * clinically significant abnormal laboratory values (as judged by the investigator) * close relative with type 1 diabetes mellitus (father, mother, sister or brother) * intake of alcohol within the last 24 hours prior to screening and drug administration visits * blood donation or blood loss of more than 500 ml within the 3 last months before screening * strenuous exercise within 48 hours before screening as well as drug administration and followup * smoking during the past month before drug administration
treatment of patients with major depressive disorder with mk0869 (0869-068)(completed)

Conditions: Major Depressive Disorder

Summary: a clinical study to determine the efficacy and safety of an investigational medication (mk0869) in the treatment of depression.

the duration of treatment is 10 weeks.

Eligibility criteria:
patients with major depressive disorder
near death experience (nde) and migraine

Conditions: Migraine; Near Death Experience

Summary: migraine is a common disabling primary headache disorder. epidemiological studies have documented its high prevalence and high socio-economic and personal impacts. migraine affects more than 20% of the french population. however, the physiopathology of migraine is always partially known. cortical spreading depression (csd) is the widely accepted as the electrophysiologic substrate of migraine aura. csd is a slowly propagating wave of transient neuronal and glial depolarization. the near death experience (nde) is a rare, but well known phenomenon. nde are profound psychic experiences commonly occuring in life-threatening conditions. among the neurological hypotheses, epilepsy, temporal lobe disorders , rem-sleep intrusion have been discussed. however, the role of dce has never been discussed. the goals of this study are : to see if there is an epidemiological link between nde and migraine/ to specify if nde was followed by a migrainous headache.


Eligibility criteria:
inclusion criteria: * subject who experienced an nde defined by the occurrence, when the subject is in a state of clinical death or a particular state of consciousness of a following event: body output experience, disembodiment, for a tunnel and / or light; * topic recorded in the emi database (dr. postel, national center for education, research and information on the conscience; * topic agreeing to participate in the study. exclusion criteria: * patient mental condition or disorder or psychiatric history or any other factor limiting the ability to participate in an informed manner and compliant to the study; * other than obtained participation agreement.

Keywords: clinical death state of consciousness