Kornimate/medical-research-clean huggingface dataset:
neuromuscular characterisation in late adolescent and adult cystinosis patients

Conditions: Cystinosis

Summary: the primary objective of the study is to evaluate the change in motor function of patients with cystinosis. the secondary objectives of the study: * assessment of the respiratory function; * assessment of the muscle function; * assessment of swallowing disorders; * assessment radiologically of the muscular efficiency; * assessment of lean mass / fat mass ratio; * assessment of sleeping disorders; * annual assessment of evolution of above functions. all patients will be examined by experienced neuromuscular specialist (pr pascal laforêt) and pulmonologist specialized in neuromuscular disorders (pr hélène prigent). all evaluations will be performed in raymond-poincaré hospital (teaching hospital of assistance publique - hopitaux de paris (aphp) and university of paris-saclay) neuromuscular center, coordinated by pr pascal laforêt.

this is a monocentric study. the enrollment will be performed as routine care in the department of neurology - neuromuscular center of raymond poincaré hospital (aphp). patients with cystinosis will be consecutively invited to participate in the study until 20 patients are included. this will avoid selection bias if any. for eligible non included patients, a specific non-identifying registry will be set-up with a very restricted number of variables indicative of disease severity at baseline, allowing for a comparison of included and non-included patients. participating cystinosis patients will be proposed to attend a one-day hospitalization. evaluations will be performed during stable state upon baseline and during a follow-up visit 12 months later. the study expected duration is 30 months with 18 months for patients' inclusion and 12 month-follow-up.

Eligibility criteria:
inclusion criteria: * patients aged ≥ 16 years; * genetically confirmed diagnosis of cystinosis; * presenting motor deficiency of at least one muscle; * covered by health insurance. exclusion criteria: * patient refusal; * foreign patients under ame health schema; * patients under legal protection; * pregnancy or breast-feeding.

Keywords: cystinosis neuromuscular disorder respiratory function swallowing disorder
sms reminders to strengthen demand for hpv vaccination in georgia

Conditions: HPV, Human Papillomavirus Viruses, Human Papilloma Virus Vaccine

Summary: it is possible that achieving adequate hpv vaccination coverage will allow cervical cancer to be virtually eliminated. this is a priority for georgia, where the burden of mortality and morbidity from cervical cancer is high and the yearly prevalence of cervical cancer is 14.5 per 100,000 population. the objective of the intervention evaluated is to increase the uptake of the 1st dose of the hpv vaccination in georgia. the intervention aims to achieve this by providing a sms reminder informed by behavioural insights (bi) to remind caregivers of girls between 10-12 years that their daughter is due the first dose of her hpv vaccination, share information about the vaccine, and encourage them to book an appointment to receive the vaccination. four different sms messages will be compared to no sms message. the evaluation will be a 5-arm randomised controlled trial (rct) which aims to answer the research question: does each of the designed bi-informed sms reminders increase the uptake of the first dose of the hpv vaccination among eligible girls in georgia, compared to no reminder? our hypothesis is that sms reminders will increase the uptake of hpv vaccination.


Eligibility criteria:
inclusion criteria: * girls * aged 10-12 years * not yet received any doses of the hpv vaccine * with a caregiver's mobile phone number in the e-health system. exclusion criteria: * boys * girls aged less than 10 or more than 12 years * girls with no caregiver phone number in the e-health system * girls who have received 1 or 2 doses of the hpv vaccine
efficacy and safety of two doses of spd476 (mesalazine) 2.4g and 4.8g once daily, with reference to asacol 0.8g three times daily in subjects with acute, mild to moderate ulcerative colitis

Conditions: Ulcerative Colitis

Summary: the primary objective of the study was to compare the percentage of subjects in remission after 8 weeks of treatment with spd476, 2.4 g/day once daily vs placebo and spd476 4.8 g/day once daily versus placebo


Eligibility criteria:
inclusion criteria: * newly diagnosed or relapsing mild to moderate uc (score of 4-10 (inclusive) on the uc-dai scale, with a sigmoidoscopy score of =\> 1 and a pga \<=2) with compatible histology * females eligible if post--menopausal, surgically sterile or if they had a negative urine pregnancy test at screening and were on adequate contraception exclusion criteria: * subjects with relapsing uc who were in relapse for \> 6 weeks prior to baseline * subjects who relapsed on maintenace therapy with doses of mesalazine =\> 2g/day * subjects who had unsuccessfully treated their current relapse with steroids or a mesalazine dose of \> 2g/day * subjects with crohn's disease, proctitis, bleeding disorders, active peptic ulcer disease, previous colonic surgery, or those at an immediate risk of toxic megacolon or a stool culture positive for enteric pathogens * subjects who had used systemic or rectal steroids within the last 4 weeks, immunosuppressants wihtin the last 6 weeks or anti-inflammatory drugs on a repeat basis within 7 days prior to the baseline visit * subjects with hypersensitivity to salicylates and subjects with moderate/severe renal impairment
a real-world retrospective study of disease outcomes in non-severe covid-19 patient

Conditions: COVID-19 Patient

Summary: retrospective analysis of real-world disease outcomes in non-severe covid-19 patients with high risk factors of progression to severe disease, including death, without definitive anti-sars-cov-2 treatment

this is a retrospective, observational, real-world study to review outcomes of mild to moderate covid-19 patients admitted to ruijin hospital affiliated to shanghai jiaotong university school of medicine (hereinafter referred to as ruijin hospital) from march to june 2022. these patients should be with risk factors for progression to severe disease (including death) and without definitive anti-novel coronavirus (sars-cov-2) treatment. the database of this study will be the hospital information system (his) of ruijin hospital.

Eligibility criteria:
inclusion criteria: 1. age ≥18 years old; 2. a record of positive sars-cov-2 nucleic acid test results on the day of admission or on the second day; 3. diagnosed as mild or common novel coronavirus pneumonia on admission, or with at least one of the following covid-19-related symptoms on admission: fever, cough, sore throat, nasal congestion or runny nose, headache, muscle pain, nausea, vomiting, diarrhea , shortness of breath or difficulty breathing, chills or chills; 4. documented or diagnosed high risk factors for progression to severe covid-19 (including death) with one or more of the following: * age ≥ 60 years * cardiovascular disease (including congenital heart disease) or high blood pressure * chronic lung disease (eg chronic obstructive pulmonary disease \[copd\], asthma \[moderate to severe\], interstitial lung disease, cystic fibrosis and pulmonary hypertension) * diabetes * has an immunosuppressive disorder or is receiving immunosuppressive therapy (eg, long-term use of corticosteroids or other immunosuppressive drugs leading to decreased immune function) * obese or overweight (bmi\>25 kg/m2) * sickle cell disease * active cancer * chronic kidney disease * current smokers * neurodevelopmental disorders (eg, cerebral palsy, down syndrome) or other conditions that cause medical complexity (eg, genetic or metabolic syndrome and severe congenital anomalies) * need for relevant medical support (not related to covid-19) (eg tracheostomy, gastrostomy or positive pressure ventilation, etc.) exclusion criteria: 1. diagnosed with severe/critical covid-19 before or on the day of admission; 2. there is a data record of having received the following treatments before progression to severe/critical covid-19: * nematicavir/ritonavir combination package (ie paxlovid) * sars-cov-2 monoclonal antibody (ambavirumab/romisevirumab) * convalescent covid-19 plasma * other anti-sars-cov-2 drugs under investigation
clinical epidemiology of nafld in children and adolescents

Conditions: Non-Alcoholic Fatty Liver Disease; Childhood Obesity

Summary: background: non-alcoholic fatty liver disease (nafld) is rapidly increasing alongside overweight and obesity, not only in adults but also in children and adolescents. it is unknown what impact the development of nafld in childhood may have in later life. the importance of early detection and treatment lies in its potential for progression to cirrhosis, liver cancer and liver-related death, as well as its associated extrahepatic comorbidities. vibration-controlled transient elastography (vcte) with controlled attenuation parameter (cap) is an effective, non-invasive and safe diagnostic method to estimate the degree of fibrosis and steatosis in the liver, but little is known about its applicability in the paediatric population. objectives: 1) to assess the prevalence of significant liver fibrosis (lsm≥6,5kpa) using vcte, and that of non-alcoholic fatty liver disease (≥225db/m) using cap in children and adolescents. 2) to determine the optimal cut-off points of the cap to achieve maximum concordance with the magnetic resonance imaging (mri) findings in the diagnosis of mild, moderate and severe nafld in children and adolescents. methods: cross-sectional population-based study which will include 2.866 subjects aged ≥9 to ≤16 years. participants will undergo: anamnesis, physical examination, blood extraction, vcte, mri and questionnaires on socio-demographic data, personal and family medical history and lifestyle assessment. applicability and relevance: the study aims to establish the foundations for the use of vcte in children and adolescents in order to achieve early diagnosis of nafld. moreover, it will serve to understand in further detail the disease and to identify the risk groups of children and adolescents who may be at risk of developing it. ultimately, this will help determine to which subgroups of the population we need to target resources for prevention and early detection of this entity, as well as possible intervention for its treatment.


Eligibility criteria:
inclusion criteria: * subjects aged between 9 and 16 years. * subjects whose parents/legal guardians have signed the informed consent. * for subjects over 12 years: it will also be necessary to have their own signed informed consent. exclusion criteria: * subjects with previously diagnosed liver disease. * subjects receiving hepatotoxic drug treatment. * subjects with diagnosed eating disorders.

Keywords: vibration-controlled transient elastography controlled attenuation parameter lifestyle liver fibrosis primary care
efficacy of a fibrin sealant in burn surgery

Conditions: Burns

Summary: the purpose of this study is to determine the effectiveness of a fibrin glue in burn surgery with respect to hemostasis and skin graft fixation.

burn patients require extensive split-thickness skin grafting operations. these operations necessitate excision of burn wounds and the procurement of autografts. both of these result in bleeding open wounds. fibrin sealants may be of benefit in three aspects of burn surgery: 1. as a hemostatic agent on excised burns, 2. as a hemostatic agent on donor sites, and 3. as a method of fixation of skin grafts to wounds. skin grafts are routinely secured with surgical staples. patients with large burns will commonly have hundreds, even thousands of staples used during the course of their care. problems associated with the use of surgical staples include: 1. discomfort upon removal and 2. staples become deeply embedded in the tissue. if effective in securing skin grafts, fibrin glue would directly benefit burn patients by decreasing the number of staples required, and thereby decreasing the number of retained staples. fibrin sealant is produced from human fibrinogen and human thrombin from pooled plasma that is virally inactivated by a two-stage heating process. subjects will serve as their own control. they will have an area of their wound treated with the fibrin sealant and another area treated with the standard of care. both areas will be compared for hemostasis, skin graft fixation, wound healing, and cosmetic outcome.

Eligibility criteria:
inclusion criteria: * requires skin grafting of an acute or reconstructive burn wound. exclusion criteria: * active disseminated intravascular coagulation (dic) or known hypersensitivity to bovine protein.

Keywords: burns hemostasis skin graft surgical hemostasis grafting, skin
impact of anti-giardia and antihelmintic treatment on infant growth in bangladesh

Conditions: Giardiasis

Summary: this longitudinal study aimed to assess whether regular anti-giardia and antihelmintic treatment improved growth and small intestinal mucosal function of rural bangladeshi infants.

a randomised double-blind controlled intervention of 36 weeks duration was conducted in a rural community located 40kms north-west of dhaka, the capital of bangladesh. infants aged between 3 and 11 months were randomly assigned to either receiving anti-giardia and antihelmintic treatment, or anti-giardia treatment only, or a control group receiving placebos. weight and supine length were recorded every 4 weeks. every 12 weeks intestinal permeability (l/m ratio), haemoglobin, plasma albumin, alpha-1-acid glycoprotein, immunoglobulin g and giardia intestinalis specific igm titre (gsigm) and eggs of the three common geohelminths and giardia intestinalis cysts were determined.

Eligibility criteria:
inclusion criteria: * infants living in the study area
management of early-onset fetal growth restriction: angiogenic factors versus feto-placental doppler

Conditions: Fetal Growth Retardation; Preeclampsia; Placenta Diseases

Summary: this is a multicentre, open-label, randomized controlled trial. a total of 340 singleton pregnancies with an efw ≤10th percentile between 26+0 and 31+6 weeks will be recruited and randomly allocated to either the control or the intervention group. in the control group, standard doppler-based management will be used. in the intervention group, different soluble fms-like tyrosine kinase to placental growth factor ratio (sflt-1/plgf) cutoffs will be incorporated to the current protocol to adjust the frequency of ultrasounds and to plan elective delivery.


Eligibility criteria:
inclusion criteria: * pregnant women of at least 18 years old * singleton pregnancy * ultrasonographic efw ≤10th percentile between 26+0 and 31+6 weeks of gestation * gestational age confirmed by fetal crown-rump length measurement during the first trimester scan (from 11+0 to 13+6 weeks of gestation) or by in vitro fertilization dates. exclusion criteria: * major fetal malformations or genetic disorders * fetal death * refusal to give informed consent * stage iv fgr

Keywords: fetal growth restriction small for gestational age plgf sflt-1 doppler
femtosecond laser-assisted arcuate incisions versus manual arcuate incisions outcomes

Conditions: Cataract

Summary: this study is designed to compare the effectiveness of lensx laser arcuate relaxing incisions vs. manual (blade) arcuate relaxing incisions in patients with low, but significant, levels of astigmatism.

this study is a comparative, prospective, randomized contralateral eye study of visual outcomes after lensx laser arcuate relaxing incisions utilizing the woodcock nomogram at 90% thickness vs. manual (blade) fixed keratome diamond knife at 600 microns for arcuate relaxing incisions utilizing the donnenfeld nomogram. subjects will be assessed pre-operatively and at 1 day, 1 month and 3 months post-operatively. clinical evaluations will include measurement of visual acuity, manifest refraction and corneal astigmatism measurement with the lenstar and slit lamp exam.

Eligibility criteria:
inclusion criteria subjects are eligible for the study if they meet the following criteria: note: ocular criteria must be met in both eyes. * are willing and able to understand and sign an informed consent; * are willing and able to attend all study visits; * are more than 40 years of age, of either gender and any race; * are presenting for cataract surgery or refractive lens exchange with a desire to reduce astigmatism and will be implanted with a non-toric lens * have good ocular health, with no pathology that compromises visual acuity (outside of residual refractive error and cataract) * have 0.50 d to 1.75 d of regular corneal astigmatism * have potential acuity of 20/25 or better * are scheduled to have a non-toric monofocal intraocular lens (iol) (sn60wf) lens implanted in both eyes exclusion criteria if any of the following exclusion criteria are applicable to the subject or either eye, the subject should not be enrolled in the study. * irregular astigmatism (e.g. keratoconus) * corneal pathology (e.g. scar, dystrophy, pterygium, moderate-to-severe dry eye) * monocular status (e.g. amblyopia) * previous radial keratotomy, corneal refractive surgery or other corneal surgery (e.g. corneal transplant, lamellar keratoplasty) * previous anterior or posterior chamber surgery (e.g., vitrectomy, laser iridotomy) * diabetic retinopathy * macular pathology (e.g. age-related macular degeneration, epiretinal membrane) * history of retinal detachment * subjects who have an acute or chronic disease or illness that would confound the results of this investigation (e.g., immunocompromised, connective tissue disease, clinically significant atopic disease, diabetes, and any other such disease or illness), that are known to affect post-operative visual acuity. pregnancy has a known effect on the stability of refractions and visual acuity. as such, subjects who become pregnant during the study will not be discontinued but their data may be excluded from analyses of effectiveness.

Keywords: astigmatism, limbal relaxing incisions
within-subject variability of insulin detemir in children and adolescents with type 1 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 1

Summary: this trial is conducted in europe. the aim of this trial is to compare the within-subject variability of the pharmacokinetic profiles of insulin detemir and insulin glargine in children and adolescents with type 1 diabetes.


Eligibility criteria:
inclusion criteria: * type 1 diabetes for at least 12 months * body mass index (bmi) for children (6 to 12 years): 15-20 kg/m\^2 (both inclusive) * body mass index (bmi) for adolescents (13 to 17 years): 18-25 kg/m\^2 (both inclusive) * hba1c (glycosylated haemoglobin) below 11.0% according to central laboratory results * current treatment with insulin at least twice daily exclusion criteria: * any significant disease such as endocrine, hepatic, renal, cardiac, neurological, malignant, or pancreatic disease other than diabetes * receipt of any investigational product within the last four weeks * known or suspected allergy to trial products or related products
study of aeroform tissue expander for breast reconstruction

Conditions: Breast Cancer; Breast Reconstruction

Summary: this study is intended to support previous positive results of the aeroform™ patient controlled tissue expander system for breast reconstruction

the objective of this study is to provide performance and safety data to support the clinical use of the aeroform™ patient controlled tissue expander system for breast reconstruction in a patient population with a broad selection criteria

Eligibility criteria:
inclusion criteria: 1. subject is female between the ages of 18 - 70. 2. subject has elected two stage breast reconstruction with tissue expanders. 3. subject's tissue is amenable to tissue expansion. 4. subject is able to provide written informed consent. 5. subject is able and willing to comply with all of the study requirements. 6. subject has the physical, perceptual and cognitive capacity to understand and manage the at home dosing regimen. exclusion criteria: 1. subject has residual gross malignancy following mastectomy. 2. subject has a current infection at the intended expansion site. 3. subject has clinically significant radiation fibrosis at the expansion site. 4. subject has planned radiation at the intended expansion site during the time the expander is implanted. 5. subject has any co-morbid condition determined by the investigator to place the subject at an increased risk of complications (e.g., severe collagen vascular disease, poorly managed diabetes). 6. subject is currently participating in a concurrent investigational drug or device study. 7. subject is a current tobacco smoker. 8. subject is overweight with a bmi \> 33. 9. subject has currently implanted electronic device such as a pacemaker, defibrillator, neurostimulator device, or drug infusion device. 10. subject is pregnant or planning to become pregnant during the study period. 11. subject has a history of psychological condition, drug or alcohol misuse which may interfere with their ability to use the device safely. -

Keywords: breast cancer breast reconstruction breast tissue expansion breast tissue expander two stage breast reconstruction
capnography during ercp

Conditions: Hypoxemia; Complications

Summary: in the study the value of capnography for avoiding complications during sedation for ercp is evaluated.

in this randomized controlled trial the utility of capnography gets evaluated. hypoxemia may occur during sedation with midazolam and propofol. whether hypoxemia may be prevented by an additional capnographic monitoring is subject of the study.

Eligibility criteria:
inclusion criteria: * age\>=18 * scheduled for colonoscopy with midazolam and propofol sedation exclusion criteria: * no informed consent * asa v * pregnancy * prexisting hypotension, bradycardia or hypoxemia

Keywords: safety sedation gastrointestinal endoscopy colonoscopy
assessment of the increased risk of infection following an ultratrail

Conditions: Running; Immune Deficiency; Infections

Summary: the increase in the practice of running has encouraged a proliferation of studies evaluating the impact of this sport on health. a number of these studies have looked at the influence of endurance events on the immune system. after prolonged exercise, a systemic inflammatory syndrome sets in, with repercussions for the functioning of the immune system. the number of lymphocytes in the blood is reduced, the function of natural killer (nk) cells is impaired and secretory immunity is impaired. during this period of immunosuppression, often referred to as the 'open window', the host may be more susceptible to micro-organisms that bypass the first line of defence. the invetigators' hypothesis is therefore that ultratrailers are overexposed to the risk of infection due to immunodepression resulting from practising this sport. in order to support this hypothesis, the investigators would like to look at infectious complications in general and ear-nose and throat episodes (rhinitis, pharyngitis, laryngitis, etc.) in particular, which are the most common infections encountered in primary care, along with urinary tract infections.


Eligibility criteria:
inclusion criteria: * \> 18 years * participating in a grand raid de la réunion 2023 race (mascareignes, trail de bourbon, diagonale des fous) * have a companion living under the same roof during the week preceding the race and the 21 days following the race and who agrees to answer the questionnaires * do not object to the research exclusion criteria: * do not understand french * a protected adult (guardianship or curatorship) or under court protection

Keywords: immune deficiency ultra-running infection