Kornimate/medical-research-clean huggingface dataset:
efficacy study with qivc in pediatric subjects

Conditions: Influenza, Human

Summary: this phase 3 clinical study is a randomized, observer-blind, multicenter study of qivc versus a non-influenza vaccine in subjects 6 months though 47 months of age. the purpose of this study is to evaluate efficacy of qivc in the prevention of laboratory confirmed influenza a or b disease in children 6 through 47 months of age, compared to a non-influenza vaccine.


Eligibility criteria:
inclusion criteria: in order to participate in this study, all subjects must meet all of the inclusion criteria described. * individuals of 6 through 47 months of age on the day of informed consent. * individuals whose parent(s)/legally acceptable representative (lar) have voluntarily given written informed consent after the nature of the study has been explained according to local regulatory requirements, prior to study entry. * individuals who can comply with study procedures including follow-up. * individuals in generally good health as per the investigator's medical judgement. if applicable, prior to receipt of second study vaccination, subjects must be evaluated to confirm that they are eligible for subsequent vaccination. if subjects do not meet the criteria of the original inclusion criteria listed above, they should not receive additional vaccinations. exclusion criteria: * acute (severe) febrile illness. enrollment could be considered if the fever is absent for 72 hours. * history of any anaphylaxis, serious vaccine reactions or hypersensitivity, including allergic reactions, to any component of vaccine or medical equipment whose use is foreseen in this study. * clinical conditions representing a contraindication to intramuscular vaccination and blood draws. these may include known bleeding disorders, or treatment with anticoagulants in the 3 weeks preceding vaccination. * a known history of guillain-barré syndrome or other demyelinating diseases such as encephalomyelitis and transverse myelitis. * abnormal function of the immune system resulting from a clinical condition * received influenza vaccination or has had documented influenza disease in the last 6 months prior to informed consent. * prior vaccination to prevent neisseria meningitides serogroup c disease or prior infection caused by this organism. additional eligibility criteria are provided in the study protocol.

Keywords: influenza vaccine
virtual management of rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: the purpose of this study is to optimize the care of patients with ra seen in virtual consultation.

this study will be organized in two consecutive steps: 1. a first descriptive step that will consist of a retrospective analysis of virtual consultation records of patients with ra during the pandemic and lockdown period in order to analyze on which criteria the patients were assessed and followed during this period. 2. the second step will consist in evaluating the interest of the systematic use in virtual consultation of a patient reported outcome (pro), the raid (rheumatoid arthritis impact of disease) questionnaire; and analyze how its results influence the rheumatologist decision-making.

Eligibility criteria:
inclusion criteria: * patients with rheumatoid arthritis fulfilling the 2010 acr/eular classification criteria * follow-up in the rheumatology department of cochin hospital * affiliated with a social security scheme * non-opposition to participating in the study * patients with a valid email address (registration to the virtual consultation system) exclusion criteria: * opposition to participate to this research * inability to understand or speak french * patient under tutor or curator ship * patients under medical state help

Keywords: rheumatoid arthritis virtual consultation telemedicine patient reported outcome
morphine and/or nalbuphine as adjuvants in ultrasound guided interscalene block: for shoulder surgeries

Conditions: Rotator Cuff Tear

Summary: the aim of this study is to evaluate the duration of analgesia when either morphine or nalbuphine or both are used as adjuvants in sonar guided interscalene brachial plexus block for arthroscopic rotator cuff repair.


Eligibility criteria:
inclusion criteria: * patients scheduled for arthroscopic repair of rotator cuff muscle tear of the shoulder. * asa physical status i - ш. exclusion criteria: * infection at the site of injection. * coagulopathy or other bleeding diathesis. * known allergy to drugs in the study * preexisting neurologic deficits in the area to be blocked. * inability to communicate with the investigator and the hospital staff. * history of chronic opioid use. * morbid obesity bmi\>40.

Keywords: morphine nalbuphine arthroscopic rotator cuff repair ultrasound guided interscalene block
intradermal suture versus stapling for groin skin closure in vascular surgery (vasc-inf trial)

Conditions: Surgical Site Infection

Summary: surgical site infection (ssi) is one of the most frequent and fearsome complications in vascular surgery due to its high morbidity and mortality. in addition, ssi is one of the factors related to the development of prosthetic infection. consequently, it represents a significant increase in hospital stay and healthcare costs. a 2021 meta-analysis on groin ssi prevention strategies in arterial surgeries reported that using intradermal sutures could be associated with a lower ssi rate. the published results from a single-center retrospective study comparing ssi rates before and after implementing an ssi prevention protocol also suggest better outcomes with intradermal suturing. this study aims to assess the ssi incidences of both skin closure techniques in vascular surgery patients undergoing femoral artery approach through a perpendicular groin skin incision.


Eligibility criteria:
inclusion criteria: * diagnosed with chronic lower limb ischemia or aortic, iliac, or femoral aneurysm * with a scheduled surgery for one of the following indications: * femoropopliteal bypass * femorodistal bypass * aortobifemoral bypass * axillofemoral or axillobifemoral bypass * femorofemoral bypass * femoral endarterectomy * femoral approach for exclusion of an aortic aneurysm * surgical procedure with an incision perpendicular to the inguinal fold * patients who undergo both unilateral and bilateral surgical approaches \* \*note: we will consider one patient as one intervention (i.e., bilateral approaches will be quantified as one single inguinal surgical approach). in the case of bilateral procedures, the same closure technique will be used for both sides. * patients who sign the written informed consent exclusion criteria: * background of a previous surgical intervention in the groin area. * femoral approach carried out in a surgical emergency setting * femoral approach performed due to a femoral pseudoaneurysm * a surgical procedure performed with a transverse/oblique incision to the groin * a patient who withdraws consent for participating in the trial

Keywords: femoral approach intradermal suture metallic staples surgical site infection groin
an internet mediated research study to assess the quality of life of consumers with self-reported fungal nail infection (onychomycosis) during treatment with scholl fungal nail.

Conditions: Onychomycosis of Toenail

Summary: to evaluate the effect on quality of life of consumers with self-reported onychomycosis during the first 4 weeks of treatment in relation to the appearance of the infected toenail.

the appearance of the infected toe nail in those suffering from the disease may have a greater impact on quality of life than the severity of the disease. it is believed that a visual improvement in the appearance of the infected toenail at an earlier stage could have a positive impact on quality of life and encourage compliance with treatment. the aim of this consumer study is to evaluate the quality of life of consumers with onychomycosis and investigate its relation to the appearance of the infected toenail within the initial 4 weeks of treatment with scholl fungal nail following its purchase from an ecommerce platform.

Eligibility criteria:
inclusion criteria: * aged 18 years or older * consumers who have purchased the product online * consumers who are willing to participate in the study exclusion criteria: * female consumers who are pregnant or breast feeding * participants with diabetes (type i or ii)

Keywords: fungal nail infection internet mediated research study
the nature of reflux-respiratory symptoms association in difficult to treat wheezing\coughing babies

Conditions: Asthma; Cough; Wheezing

Summary: ger and respiratory symptoms are both common phenomenon in children. both can coexist in the same patient by chance alone. research reveals increased incidence for both to coexist leading to suspect a temporal association and possible causality. therefore we conducted an observational study to determine the primary cause (rs or ger)using for the first time both ph-impedance as measurements of ger and wheezy monitoring (weem) that records simultaneously wheeze and cough noises. both modalities will be recorded for 12-24 hours. if ger precedes cough/wheeze recordings it points to ger being the possible precipitating factor and vice versa.

ger and respiratory symptoms are both common phenomenon in children. both can coexist in the same patient by chance alone. research reveals increased incidence for both to coexist leading to suspect a temporal association and possible causality. therefore we conducted an observational study to determine the primary cause (rs or ger)using for the first time both ph-impedance as measurements of ger and wheezy monitoring (weem) that records simultaneously wheeze and cough noises. both modalities will be recorded for 12-24 hours. if ger precedes cough/wheeze recordings it points to ger being the possible precipitating factor.however, if cough/wheeze precedes ger recordings it points to cough/wheeze being the possible precipitating factor. the recordings will be investigated 1 minute before and one minute after each event.

Eligibility criteria:
inclusion criteria: * children 1 month - 18 years old * difficult to treat asthma * difficult to treat cough * difficult to treat other respiratory symptoms exclusion criteria: * children on artificial ventilation * children not compliant with ph-metria and/or weem

Keywords: ger gastrointestinal reflux aspiration ashtma cough wheeze ph-impedance weem wheezy monitor
assessment of the safety and efficacy of rgn-259 ophthalmic solutions for dry eye syndrome: arise-3

Conditions: Dry Eye Syndromes; Dry Eye

Summary: the objective of this study is to compare the safety and efficacy of rgn-259 ophthalmic solution to placebo for the treatment of the signs and symptoms of dry eye.


Eligibility criteria:
inclusion criteria: * be at least 18 years of age; * provide written informed consent; * have a subject reported history of dry eye for at least 6 months; * have a history of use or desire to use eye drops for dry eye symptoms within 6 months exclusion criteria: * have any clinically significant slit-lamp findings at visit 1 that may include active blepharitis, meibomian gland dysfunction (mgd), lid margin inflammation or active ocular allergies that require therapeutic treatment, and/or in the opinion of the investigator may interfere with study parameters; * be diagnosed with an ongoing ocular infection (bacterial, viral, or fungal), or active ocular inflammation at visit 1; * have an uncontrolled systemic disease; * be a woman who is pregnant, nursing or planning a pregnancy

Keywords: dry eye dry eye syndrome des
whole-body mr in staging bone and soft tissue metastases in breast cancer patients(metamarbo)

Conditions: Breast Cancer

Summary: prospective mr-imaging study : role of magnetic resonance (mr) and diffusion weighted imaging (dwi) mr in staging and therapy assessment in breast cancer patients with bone metastases.

about 50 patients with a proven breast cancer and bone metastases will be included. first step : staging * nuclear bone scan * positron emission tomography (pet/ct) * mr (whole body short tau inversion recovery (stir)-sequence and t1-sequence and diffusion weighted imaging (dwi),no contrast administration aim : * validation of whole body diffusion weighted imaging in detection of bone metastases and visceral metastases, comparing to bone scan en pet/ct results. * to calculate cut-off values for dwi for bone and visceral metastases. second step : therapy follow-up/therapy assessment. * two groups of patients (oncologist takes the decision about therapy) 1. patients treated by chemotherapy 2. patients treated by hormonal therapy * on week 3, 12-16 and 52 in the chemotherapy or hormonal therapy-setting, a whole body mr (same protocol, no contrast) will be performed. end-point: whole body mr with dwi is useful and reliable to assess the treatment response.

Eligibility criteria:
inclusion criteria: 1. patients with a proven breast cancer (by biopsy or imaging) 2. bone metastases proven by mr, pet-ct or bone. patients with visceral metastases can be included if bone metastases are also present. 3. patient with an informed consent. exclusion criteria: 1. patients with a single bone metastasis treated by radiotherapy will be excluded. 2. patients with contra-indication for mri: pacemaker, cochlear implant, non mr compatible devices (baclofenpump). 3. claustrophobia 4. patient in a bad general condition.

Keywords: breast cancer metastasis bone diffusion mri
hbsag loss adding pegylated interferon in hbeag-negative patients

Conditions: Chronic Hepatitis B (HBeAg-negative)

Summary: chronic hepatitis b (chb) affects more than 350 million people worldwide. the most common form in europe is chb hbeag-negative. antiviral treatment of chb hbeag-negative patients includes chronic administration of nucleos(t)ide analogues (nuc) or pegylated interferon (pegifn) during 12 months. typically, pegifn allows immune control of chb and antigen "s" (hbsag) loss in around 4% of patients compared to less than 0,1% using nuc. recently, it has been described that hbsag quantification (hbsag-q) is useful to identify patients with high probability to lose hbsag during follow-up. in addition, a proof-of-concept study with nine hbeag-negative patients receiving nuc showed that adding pegifn (16 weeks) achieved hbsag loss in one patient (11%). the aim of our study is to evaluate the efficacy and safety adding pegifn (48 weeks) in treated hbeag-negative patients with nuc.


Eligibility criteria:
inclusion criteria: * chronic hepatitis b (hbeag-negative) * signed inform consent * aged \> 18 exclusion criteria: * contraindications for pegylated interferon (cirrhosis, pregnancy, others) * previous treatment with interferon or pegylated interferon * previous hbsag loss * treatment duration with nucleos(t)ide analogues less than 2 years * poor adherence to nucleos(t)ide analogues
study of ambrisentan in participants with pulmonary hypertension

Conditions: Pulmonary Hypertension

Summary: the primary objective of this study is to monitor the long-term safety of ambrisentan in adult participants with pulmonary hypertension. the available ambrisentan doses for this study are 2.5, 5, or 10 mg administered orally once daily. investigators will be able to adjust ambrisentan dose as clinically indicated. a minimum of 4 weeks between dose adjustments is required. participants receiving other therapies for pulmonary hypertension that are not contraindicated for concomitant use with ambrisentan are permitted to enroll in this study and continue to receive such therapies. participants enrolled in this study will receive treatment with ambrisentan until such time as the investigator or participant chooses to stop ambrisentan treatment, ambrisentan becomes commercially available, or the sponsor stops the study.


Eligibility criteria:
key inclusion criteria: * men and women with pulmonary hypertension who are discontinuing a clinical study of ambrisentan due to study closure by the sponsor. eligible participants are those participating in countries where ambrisentan is not yet commercially available. participants participating in countries where ambrisentan is commercially available may be eligible if they do not qualify for treatment per the current prescribing information of that country. key exclusion criteria: * participants who have discontinued an ambrisentan clinical study for any other reason than sponsor-initiated study closure are not eligible. note: other protocol defined inclusion/exclusion criteria may apply.
chromogranin-a-derived peptides and periodontitis in diabetic patients

Conditions: Periodontitis and Diabetitis

Summary: periodontitis is a chronic disease of the supporting tissue of the teeth, characterized by bleeding and inflamed gingival, resorption of alveolar bone. this disease has a significant impact of the quality of life as the teeth become progressively mobile and may fall out spontaneously if no treatment is provided. periodontal disease has been cited as the sixth complication of diabetes mellitus.chromogranins / secretogranins are a family of proteins present in nervous endocrine and immune cells, released with catecholamines during stress situations. chromogranin a (cga) is the major member of this family.the aim of this study is to determine the level of cga and its derived peptides in the gingival crevicular fluid (gcf) of health or diabetic patients with and without periodontitis.then, we want to determine the antimicrobial activity of these peptides.


Eligibility criteria:
inclusion criteria: * patients from 20 to 80 years old * a minimum of 10 teeth * healthy volunteers or diabetic patients with or without periodontitis exclusion criteria: * a course of antibiotics * a fungicidal therapy * a corticotherapy * a hormone therapy * a pregnancy * persons under guardianship

Keywords: periodontitis diabetes gingival crevicular fluid gcf saliva chromogranin electrophorèse western blot rt-hplc
safety study of suprachoroidal triamcinolone acetonide via microneedle to treat uveitis

Conditions: Uveitis; Intermediate Uveitis; Posterior Uveitis; Panuveitis; Noninfectious Uveitis

Summary: this study is designed to determine the safety and tolerability of a single microinjection of triamcinolone acetonide (triesence®) into the suprachoroidal space (scs) of patients who have non-infectious uveitis.

this is a phase 1/2, open-label study designed to evaluate the safety, tolerability and procedure of a microneedle injection of triamcinolone acetonide (ta) into the scs. the subjects enrolled in this study will be chosen from subjects with non-infectious intermediate, posterior and pan-uveitis. the injection will only be administered to a single eye via the clearside biomedical proprietary microneedle into the scs. the dose of ta to be injected is 4 mg of currently approved triesence® (triamcinolone acetonide injectable suspension 40 mg/ml). the study design includes 10 clinic visits over 27 weeks. subjects will be followed for 26 weeks following treatment with triesence®.

Eligibility criteria:
inclusion criteria: * diagnosis of non-infectious intermediate, posterior or pan-uveitis exclusion criteria: * any ocular trauma within the past 6 months in the study eye * any injection of intraocular corticosteroids or steroid implant or the ozurdex® implant in the 6 months prior to the study treatment, or any prior use of retisert™ in the study eye * any uncontrolled systemic disease that would preclude participation in the study or put the subject at risk due to study treatment or procedures * have a known hiv infection or other immunodeficiency disease for which corticosteroid therapy would be contraindicated * are monocular * have ocular hypertension * history of any intraocular surgery in the study eye * presence of an anterior staphyloma in the study eye

Keywords: uveitis intermediate uveitis posterior uveitis panuveitis noninfectious uveitis microneedle suprachoroidal space scs inflammation ocular inflammatory conditions triamcinolone acetonide ta triesence injection ivt intravitreal corticosteroid sympathetic ophthalmia temporal arteritis vitreous haze
cross transmissions of pseudomonas aeruginosa between children from a same cystic fibrosis center.

Conditions: Cystic Fibrosis; Pseudomonas Aeruginosa; Cross Infection

Summary: cystic fibrosis is the most common hereditary autosomal recessive disease in the caucasian population. the diseases is caused by a mutation of the gene coding for the cftr protein (cystic fibrosis transmembrane conductance regulator), an ion channel present at the apical pole of the epithelial cells. the channel dysfunction induces a deficit in hydration and a hyperviscosity of different exocrine secretions. clinically, cystic fibrosis is a multi-systemic disease. pulmonary and pancreatic involvement are classically in the foreground. degradation of respiratory function, associated with acute and chronic infections, represents the major cause of morbidity and mortality. pseudomonas aeruginosa is a ubiquitous gram-negative bacillus found primarily in stagnant water. pseudomonas aeruginosa is capable of colonizing the digestive, pulmonary and urinary mucosa and the skin. this bacterium is incriminated in many opportunistic infections including respiratory infections in patients with cystic fibrosis. pseudomonas aeruginosa infection is the most common parenchymal lung infection in the cystic fibrosis community. pseudomonas aeruginosa chronic carriage represents a factor of poor prognosis associated with an increase in morbidity and mortality. complications related to chronic carriage of pseudomonas aeruginosa justify the implementation of strategies of eviction, screening and eradication of acute pseudomonas aeruginosa infection. in addition to pseudomonas aeruginosa contamination of patients via the environment, hand and airborne infections between patients with cystic fibrosis have been reported. measures to eliminate cross-transmissions have therefore been implemented in a majority of hospitals. the aim of the study is firstly to identify the number of pseudomonas aeruginosa cross-transmissions between patients with cystic fibrosis followed-up in cystic fibrosis center of huderf. investigator will use the pulsed-field gel electrophoresis to assess the possibility of cross-infection. depending on the results, investigator will implement new strategies to avoid future cross-contamination in our different places of care (consultation, hospitalization, physiotherapy...).


Eligibility criteria:
inclusion criteria: * cystic fibrosis patients aged 0-20y followed in cystic fibrosis at huderf * for each participant, both parents or legally acceptable representative(s) must sign an informed consent form (icf) indicating that they understand the purpose of, and procedures required for, the study and is willing to allow the child to participate in the study. * assent is also required of children capable of understanding the study (typically participants 7 years of age and older). exclusion criteria: * none