Kornimate/medical-research-clean huggingface dataset:
duration of face down positioning for full-thickness macular hole repair

Conditions: Macular Holes

Summary: a full-thickness macular hole is when there is a small gap that opens in the center part of the retina (the light-sensitive layer of tissue in the back of the eye). following surgical repair of these holes, patients have to lie face down for a number of days and nights. the exact amount of time necessary to position is however unknown. the goal of this randomized feasibility clinical trial is to compare 3 days and nights of face-down positioning to 7 days and nights of face-down positioning following pars plana vitrectomy surgery for full-thickness macular holes on key patient outcomes. this study will be a feasibility study to better inform a future larger clinical trial. additionally, this investigation will be examining the rates of macular hole closure, patient visual acuity following surgery, patient quality of life, patient compliance, and complication rates.


Eligibility criteria:
inclusion criteria: * consecutive patients with an idiopathic full-thickness macular hole * symptom duration of less than 6 months * patient must agree to participate in this investigation exclusion criteria: * macular hole minimum diameter \>1000 μm * a history of high myopia (\> -6) * traumatic macular hole * amblyopia * retinal vein occlusion * inflammatory eye diseases * patients found to have a retinal tear during either the pre-operative assessment or intraoperatively
postoperative troponin in renal dysfunction after cardiac surgery

Conditions: Renal Dysfunction

Summary: elevated level of troponin is frequently observed among patients with renal dysfunction. increase in troponin after cardiac surgery may predict postoperative outcome in cardiac surgery patients. however, the relationship between the increased troponin and outcome after cardiac surgery has not been fully elucidated in patients with renal dysfunction.

this is a retrospective observational study to evaluate the prognostic value of postoperative troponin in patients with renal dysfunction undergoing cardiac surgery. electrical medical records of patients who underwent cardiac surgery between 2004 and 2015 will be assessed. perioperative laboratory data including troponin and glomerular filtration rate, type of surgery, and outcome variables including mortality will be analysed to determine the prognostic value of postoperative value of postoperative troponin in patients with renal dysfunction undergoing cardiac surgery.

Eligibility criteria:
inclusion criteria: * patients with renal dysfunction who underwent cardiac surgery between 2004 and 2015 at seoul national university hospital exclusion criteria: * patients without laboratory information on glomerular filtration rate or troponin levels

Keywords: cardiac surgery troponin mortality
nuedexta for the treatment of adults with autism

Conditions: Autism

Summary: primary: demonstrate reduced frequency and intensity of maladaptive behaviors as measured by the aberrant behavior checklist (abc) irritability subscale in subjects given nuedexta 8 weeks over subjects given placebo. secondary: demonstrate a trend towards reduced aggressive behavior as measured by overt aggression scale (oas).

this is a randomized placebo-controlled crossover study. the parents, neuropsychologists, clinical research coordinator (crc) and pi will be blinded as to whether subjects are on placebo or nuedexta. nuedexta will be given once daily for 7 days. if well-tolerated, it will be given every 12 hours for the next 7 weeks. patients may also remain on the once-daily dose if desired. the study will last 44 weeks. this includes 20 weeks for study enrollment, 8 weeks of treatment/placebo, 4 weeks for washout, and a second 8 week-period of treatment/placebo followed by 4 weeks of washout. subjects will be randomized to 8 weeks of nuedexta/placebo. after the 8 week follow-up visit, there will be a 4 week washout period. at week 12 (second baseline), the groups will crossover for another 8 weeks of nuedexta/placebo. study endpoints will be measured in the both groups at weeks 8, 12, and 20. a final study visit will occur at week 24.

Eligibility criteria:
inclusion criteria: 1. 18 to 60 years of age 2. have a collateral informant who can attend visit and answer questionnaires pertaining to participant behavior 3. diagnosis of autistic spectrum disorder based on the diagnostic and statistical manual, 4th edition, text revised (dsm-iv-tr) criteria, developmental history, and autism diagnostic observation schedule (ados); or confirmed diagnosis of autism during childhood through similar methods 4. capable of giving informed consent, or have a legal guardian capable of giving consent on the subject's behalf; patient able to assent to participate 5. mood issues and frontal lobe type perseveration issues 6. no medication changes within 30 days and no use of new medications during the course of the study except for non-related conditions approved by the investigators exclusion criteria: 1. clinically uncontrolled epilepsy 2. cardiovascular conditions including cardiac or structural malformation heart failure, prolonged qt interval, history of torsades de pointes, or atrioventricular (av) block 3. known genetic disorders, fragile x, or known brain structural abnormalities, cerebral palsy, head injury, or brain tumor 4. known allergy to either dextromethorphan or quinidine 5. concurrent or recent use of monoamine oxidase inhibitor (maoi) antidepressants pt nuedexta 6. concurrent use of lamotrigine or felbamate or other n-methyl-d-aspartate (nmda) agonists or antagonists 7. thrombocytopenia, hepatitis, bone marrow depression or lupus-like syndrome 8. pregnancy - sexually active females of childbearing potential must be on a reliable form of contraception 9. other clinically significant abnormality on physical, neurological, laboratory, vital signs, that could compromise the study or be detrimental to the subject

Keywords: adults
the effect of the transversus abdominis plane block to postoperative analgesia for cesarean section

Conditions: Obstetric Pain

Summary: the transversus abdominis plane block (tap block) has effect to postoperative analgesia for cesarean section with spinal anesthesia but it was limited for cesarean section with general anesthesia. the hypothesis that this technique has effect to postoperative analgesia for cesarean section with general anesthesia and it could reduce 50% of total morphine consumption during 24 hours after surgery.

this is a randomized, controlled, no-blind clinical trial. the investigators selected 60 cases, who were cesarean section under general anesthesia, age from18 years, and american society anesthesiologists (asa) classification was from ii-iii. the cases of acute fetal impairment, local anesthesia contraindication, tolerance opioids, liver failure, renal failure, and spinal anesthesia failure were excluded. all cases were randomized assigned two groups: the tap block group (t group) and controlled group (c group). each group has 30 cases. the tap block was performed under the ultrasound guidance with 0.25% of ropivacaine 20 ml each side. the both groups was treated postoperative analgesia with intravenous morphine to patients controlled analgesia (pca). the primary outcome was total morphine consumption during 24 hours after surgery. the secondary outcomes were the time of required the first dose of morphine, pain score, the complications of tap block, the side effects of morphine, and satisfaction score of participants. data was described and analyzed with spss 25.0. the sample size was calculated with the hypothesis that tap block could reduce 50% of dose morphine during 24 hours after surgery, 80% of power, 10% of loss, and 0.05 of alpha error.

Eligibility criteria:
inclusion criteria: * cesarean section with general anesthesia. * the asa classification was from ii to iii exclusion criteria: * the acute fetal impairment. * the severe live or renal failure. * tolerance opioids

Keywords: transversus abdominis plane block (tap block) postoperative analgesia cesarean section
rerouting seton versus lift for complex anal fistula

Conditions: Anal Fistula

Summary: this study aims to compare the efﬁcacy of two surgical techniques in treatment of complex anal fistulas. the first technique involves rerouting of the fistula tract with placement of a vessel loop seton around the internal anal sphincter, sparing the external sphincter whereas the second technique entails ligation of inter-sphincteric fistulous tract (lift). the main objectives of the study are to assess the success rate, time to healing, change in quality of life, and complications of each procedure including fecal incontinence.


Eligibility criteria:
inclusion criteria: * adult patients of either sex with complex anal fistula including high trans-sphincteric, supra-sphincteric, extra-sphincteric, and anterior fistula in female exclusion criteria: * patients with simple anal fistulas, including intersphicnteric and low trans-sphincteric fistulas. * asa iv and v (the american society of anesthesiologists physical status classification system) unfit patients * patient with any grade of anal incontinence. * patients with concomitant anal pathology.
the effect of extracorporeal shock wave therapy on spasticity

Conditions: Spasticity

Summary: the effect of traditional treatment for spasticity is barely satisfactory. the shock wave has been used to treat the spasticity with expressively response and the effect could persist for 1-3 months in different studies. however most sutdies lack the sham or control group. the purpose of this study was to assess the effect of shock wave for spasticity in wrist and hand.

the patients with spasticity for at least 6 months were randomized for 3 groups. group i: patients receive one session of shock wave per week for 3 weeks; group ii: patients receive only one session of shock wave; group iii: patients receive the sham shock wave per week for 3 weeks. the outcome measurements include modified asthow scale, passive range of motion, disability assessment scale and fugl-meyer assessment scale (hand function and wrist control).

Eligibility criteria:
inclusion criteria: age between 20-80 year-old spasticity measured as modified asthow scale more than 1+ point and persist at least 6 months clear consciousness no receive phenol injection or botulinum toxin in past 6 months exclusion criteria: cancer joint contracture coagulopathy pregnancy pacemaker inflammation status

Keywords: shock wave spasticity effect
effects of orthopedic mandibular advancement in class ii division 1 malocclusion on pharyngeal airway

Conditions: ClassII Division 1 Malocclusion; Mandibular Retrognathism

Summary: this study aims at evaluating the effects of mandibular advancement on pharyngeal airway space and nocturnal breathing in children with skeletal class ii division1 malocclusion. fifty patients will be enrolled in the study divided into control and experimental groups.

the purpose of the present research is not only evaluate the effect of functional appliance on the pharyngeal airway space, but also evaluate its effect on nocturnal breathing of children with skeletal class ii.

Eligibility criteria:
inclusion criteria: 1. skeletal class ii division 1 malocclusion due to mandibular retrognathism. 2. cephalometric angular measurements: sna ≥ 82, snb ≤ 78, anb ≥ 4. 3. overjet ≥ 6 mm. 4. patient in circumpubertal stage cvm2 and cvm3. exclusion criteria: 1. history of orthodontic treatment. 2. presence of craniofacial anomalies or tmj disorders. 3. systemic problems that may affect craniofacial growth. 4. abnormal oral habits.
study of how single rising doses of sar161271 are absorbed and act in patients with type 1 diabetes mellitus (t1dm)

Conditions: Type 1 Diabetes Mellitus

Summary: primary objective: - to establish initial safety/tolerability and pharmacodynamic and pharmacokinetic profiles of four formulations of sar161271 in patients with t1dm. secondary objective: - to establish relative potency of sar161271 compared with insulin glargine in patients with t1dm

the total per patient is between 31 and 67 days; including post-study visit between 108 and 172 days. in case of an additional late post-study visit after last dosing, approximately 213 to 279 days, broken down as follows: * screening: 3 to 27 days; * treatment periods each 1 day with institutionalisation from day -1 to day 3; * wash-out between doses: 7 to 10 days; * end of study visit: 7 to 10 days after last dose. * post-study visit 84 to 112 days after last dosing. if necessary, additional post-study visit 6 to 7 months after last dosing.

Eligibility criteria:
inclusion criteria: * patients who have type 1 diabetes mellitus (t1dm) as defined by american diabetes association average total insulin dose of \<1.2 u/kg/day * fasting negative serum c-peptide (\<0.3 nmol/l) * glycated hemoglobin (hba1c) \< or = 9% * stable insulin regimen for at least 2 months before the study * body weight between 50-110 kg inclusive; body mass index between 18-30 kg/m2, inclusive * certified as healthy for t1dm by a comprehensive clinical assessment exclusion criteria: * any history or presence of clinically relevant (for t1dm) cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, psychiatric, systemic, ocular, or infectious disease, or signs of acute illness, or major diabetic complications such as diabetic retinopathy. * blood donation, any volume, within 1 month before inclusion. * presence or history of drug hypersensitivity, or allergic disease diagnosed and treated by a physician * regular use of any medication other than insulins in the last month before study start with the exception of thyroid hormones, metformin, lipid-lowering and antihypertensive drugs * positive reaction to any of the following tests: hepatitis b surface (hbs) antigen, anti-hepatitis c virus (anti-hcv) antibodies, anti-human immunodeficiency virus (hiv) 1 antibodies, anti-hiv2 antibodies. the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
open-label influenza vaccine evaluation

Conditions: Immune Response

Summary: this is an open-label, randomized trial in up to 210 adults aged 65-74 years to evaluate the immune response to consecutive influenza vaccination across 2 seasons. participants will be randomized to receive 1 of 3 licensed and recommended vaccines in the first year; 2 arms will receive the same vaccination in the second year and the third arm will be randomized again to 1 of 3 licensed vaccines. all participants will have pre and post-vaccination serum blood draws for a total of 6 draws over 18 months.


Eligibility criteria:
inclusion criteria: * age 65-74 years at the time of study enrollment and are ambulatory and live in selected wisconsin community or surrounding communities. * willing and able to give informed consent prior to study enrollment * able to comply with study requirements. exclusion criteria: * prior receipt of 2016-17 influenza vaccine * current participation in another clinical trial * presence of a contraindication to influenza vaccine

Keywords: vaccine influenza high dose adjuvanted recombinant
effectiveness of probiotics in relieving allergic rhinitis in children

Conditions: Children With Allergic Rhinitis

Summary: to evaluate the clinical efficacy of probiotic gummies in the trial of allergic rhinitis in children compared to placebo, as well as the modulating effect on gut microbiota, serum metabolic profile, and occurrence of adverse reactions.


Eligibility criteria:
inclusion criteria: 1. age 4-14 years old; 2. meet the diagnostic criteria for allergic rhinitis established in the guidelines for the diagnosis and treatment of allergic rhinitis in children (2022 revised edition); 3. symptoms: 2 or more symptoms: sneezing, watery discharge, nasal itching and nasal congestion and other symptoms persist or accumulate for more than 1 hour per day, and may be accompanied by eye symptoms such as itching, watery eyes and red eyes; 4. signs: pale and edema of the nasal mucosa, which may be accompanied by watery discharge; exclusion criteria: 1. drugs that affect the intestinal flora have been used continuously for more than 1 week within 1 month before screening; 2. patients with pulmonary tuberculosis; 3. combined with allergic asthma; 4. those with nasal polyps or severe nasal septum deviation; 5. patients with severe systemic diseases or malignant tumors; 6. those with congenital genetic diseases and congenital immunodeficiency diseases; 7. those who regularly use probiotics or prebiotics within 6 months before the screening period; 8. those with severe digestive tract diseases (including severe diarrhea, inflammatory bowel disease, etc.); 9. patients with metabolic syndrome (including obesity, dyslipidemia, hypertension, diabetes, etc.); 10. patients with sinusitis, otitis media, or respiratory tract infection; 11. those who are allergic to the probiotic-related ingredients used in this trial; 12. subjects who are judged by other investigators to be insuitable to participate.
effects of nmes on muscle function of patients with fshd: a double-blind randomized controled clinical trial

Conditions: Primary Disease Facioscapulohumeral Dystrophy (FSHD)

Summary: facioscapulohumeral muscular dystrophy (fshd) is an autosomal dominant disease characterized by progressive weakness and atrophy of specific skeletal muscles. one of the major problems of patients affected by fshd is the limitation in performing daily activities induced by the progressive muscle weakness. this sedentary lifestyle can cause a "debilitative cycle," and neuromuscular deconditioning can even aggravate the muscular deficiencies. recent studies have indicated the safety and the effectiveness of moderate aerobic training programs in patients with fshd. however, these training programs have limited applicability in patients with more severe muscular weakness. artificial strength training by means of neuromuscular electrical stimulation (nmes) appears to be a promising rehabilitation strategy for fshd patients suffering from neuromuscular disorders. therefore we propose to investigate the feasibility, safety, and effectiveness of nmes strength training to counteract quadriceps muscle weakness in patients affected by fshd.

nmes will be delivered to both quadriceps by means of a kneehab® xp device, which is an innovative and clinically-proven garment-based product designed specifically to treat quadriceps muscle atrophy. the main nmes current parameters are: 50-hz frequency, 100-400 µs pulse duration, 5:10-second on:off time. each session will last approximately 20 minutes and will be repeated 5 days/week for a total duration of the treatment program of 3 months.

Eligibility criteria:
inclusion criteria: * molecular and/or clinical diagnosis for fshd * vignos scale ≤ 5: able to walk without help * clinically characterized by quadriceps muscle weakness but with a maximal voluntary contraction (mvc) between 8 and 16 kg * follow as part of their usual care in the clinical physiology department of the university hospital of montpellier * free and informed consent of the patient * patient affiliated or beneficiary of a social security system exclusion criteria: * patient with co-morbidity:pathologies heart, pathologies respiratory, metabolic and endocrine -pathologies, pathologies cancer. * patients treated with drugs could cause muscle side effects or interfere with muscle metabolism. * lesions or skin inflammation at the thighs that can prevent the application of nmes * claustrophobic subject * carrier of intracranial vascular clip, cardiac pacemaker, neurostimulator, cochlear implant, or intraocular metallic foreign * pregnant or nursing women * vulnerable persons and protected major or unable to consent * patient in exclusion period relative over another protocol, or for which the annual amount of maximum compensation of € 4,500 has been reached

Keywords: muscle function oxidative stress quality of life physical activities
prediction of recurrent events with 18f-fluoride

Conditions: Coronary Artery Disease; Myocardial Infarction

Summary: this is a multi-centre observational study. it will make use of the positron emission tomography (pet) tracer 18f-sodium fluoride (18f-naf) as a marker of coronary plaque vulnerability to detect culprit and non-culprit unstable coronary plaques in patients with recent myocardial infarctions. the investigators will then perform long-term follow-up of these patients to determine the prognostic significance of coronary 18f-naf uptake

the investigators intend to recruit 700 patients hospitalised with myocardial infarction and proven multivessel coronary artery disease. all patients will undergo a combined ct coronary angiogram (ctca) and pet scan using 18f-naf as a tracer. patients will then have clinical follow-up before undergoing a repeat ctca at 2 years to assess progression of coronary disease. clinical review of all patients will continue until study completion (given 2 years of recruitment this is likely to last 4 years) and following this the investigators will continue to monitor for further cardiovascular events via review of patient electronic health records for a further 5 years.

Eligibility criteria:
inclusion criteria: 1. patients aged ≥50 years with recent (\ 50% luminal stenosis, or (b) previous revascularization (percutaneous coronary intervention or coronary artery bypass graft surgery). 2. provision of informed consent prior to any study specific procedures exclusion criteria: 1. inability or unwilling to give informed consent 2. women who are pregnant, breastfeeding or of child-bearing potential (women who have experienced menarche, are pre-menopausal and have not been sterilised) will not be enrolled into the trial 3. major intercurrent illness with life expectancy \<2 year 4. renal dysfunction (estimated glomerular filtration rate ≤30 ml/min/1.73 m2) 5. contraindication to iodinated contrast agent, positron emission tomography or computed tomography 6. atrial fibrillation 7. previous recruitment into the trial
influenza vaccine in children with asthma

Conditions: Asthma in Children; Influenza Vaccine; Immunization Coverage

Summary: the occurence of influenza can be a factor of imbalance of asthma. asthma patients are recommended for annual influenza vaccination . however there is insufficient vaccination coverage of asthmatic patients despite this recommendation. the aim of this study is to evaluate the rate of influenza vaccination coverage of children with asthma aged from 6 month to 17 years of age followed in pediatric pneumology consultation at the university hospital of nancy.

using a questionnaire, the investigator will estimate the percentage of the asthmatic patients vaccinated against influenza. he will then compare the 2 groups of vaccinated and unvaccinated patients : comparison of patients characteristics, comparison of asthma characteristics (severity, asthma control...). he will also analyze the causes of vaccination or non-vaccination.

Eligibility criteria:
inclusion criteria: * asthmatic patients followed in pediatric pneumology consultation at university hospital of nancy aged from 6 months to 17 years exclusion criteria: * asthmatic children who have been followed for less than 1 year