Kornimate/medical-research-clean huggingface dataset:
zinc and/or probiotic supplementation of rotavirus and oral polio virus vaccines

Conditions: Immunity to Oral Rotavirus Vaccine; Immunity to Oral Polio Vaccine; Shedding of Oral Rotavirus Vaccine

Summary: background: strategies are needed to improve oral rotavirus vaccine (rv), which provides suboptimal protection in developing countries. probiotics and zinc supplementation could improve rv immunogenicity by altering the intestinal microbiota and immune function. this study enrolled infants 5 weeks old living in urban vellore, india to assess the effects of daily zinc (5 mg), probiotic (1010 lactobacillus rhamnosus gg) or placebo on the immunogenicity of two doses of rv (rotarix,glaxosmithkline biologicals) given at 6 and 10 weeks of age. probiotics and zinc (or placebo) were provided for six weeks. a single dose of test product was administered daily one week prior to first study dose of rotavirus and polio vaccines through 1 week following second study dose of rotavirus and polio vaccines.

co- primary objectives: 1. to evaluate the serologic immune response to rotavirus vaccine (sero-conversion or four-fold rise in rotavirus immunoglobulin a (iga) antibodies) among indian infants receiving zinc supplementation given daily for a week prior to the administration of the first dose through a week following the second dose of oral rotavirus vaccine compared to those receiving a zinc placebo. 2. to evaluate the serologic immune response to rotavirus vaccine (sero-conversion or four-fold rise in rotavirus iga antibodies) among indian infants receiving probiotic supplementation given daily for a week prior to the administration of the first dose through a week following the second dose of oral rotavirus vaccine compared to those receiving a probiotic placebo.

Eligibility criteria:
inclusion criteria: * infants 35-41 days old * live in area under surveillance * current weight ≥3.2 kg * no syndromic evidence of immunocompromise as determined by medical doctor * no prior illness requiring hospitalization * no current medical condition as determined by medical doctor which precludes study involvement * available for follow up for duration of study (through approximately 14 weeks of age) * parents/guardians of infant are able to understand and follow study procedures and agree to participate in the study by providing signed informed consent exclusion criteria: * child has history of atopic symptoms * child has a known digestive system defect * child has history of chronic diarrhea * child has major congenital anomalies * child has received a prior dose of rotavirus vaccine * child has received a prior dose of polio vaccine (beyond the birth dose)

Keywords: rotavirus polio zinc supplement probiotic supplement rotavirus vaccine shedding
effect of levodopa-carbidopa on visual function in patients with recent-onset nonarteritic anterior ischemic optic neuropathy

Conditions: Nonarteritic Anterior Ischemic Optic Neuropathy

Summary: purpose: there are some controversies about the effect of levodopa-carbidopa on treatment of non-arteritic anterior ischemic optic neuropathy (naion). this study was performed to evaluate the effect of levodopa-carbidopa on visual acuity, color vision, and visual field in patients with recent onset naion (less than 6 weeks duration). patients and methods: in this double-blind randomized clinical trial, 13 patients were treated with levodopa-carbidopa and 12 patients took placebo for 3 weeks. visual acuity, color vision, and visual field were tested before and at 4th, 12th, 16th, and 24th weeks after enrollment, and evaluated.


Eligibility criteria:
inclusion criteria: * age greater than 50 years old * first ophthalmic examination within 6 weeks after onset of disease * presence of optic disc swelling followed by optic atrophy within 6 weeks * altitudinal, central or generalized visual field defect * normal esr exclusion criteria: * confirmed giant cell arteritis * history of any ocular surgeries * optic neuropathy due to acute bleeding * advanced diabetic retinopathy * uncontrolled glaucoma * any ocular disorders that cause visual acuity reduction rather than naion
report 2 cases of massive incarceration necrosis rectal prolapse are successfully treated with altemeier's procedure

Conditions: Rectal Prolapse

Summary: incarceration and necrosis of rectal prolapse is rare and often requires urgent management. perineal rectosigmoidectomy (altemeir procedure) is a reasonable technique for this condition. the need for a diverting stoma depends on the patient's condition and the experience and judgement of the surgeon. a literature review was performed to determine optimal management of incarcerated and necrotic rectal prolapse, and to determine the indication for fecal diversion.


Eligibility criteria:
inclusion criteria: * 2 cases incarceration rectalprolapse exclusion criteria: * n/a
r-one efficiency for pci evolution with robotic assistance

Conditions: Coronary Artery Disease; Percutaneous Coronary Intervention

Summary: this study is a prospective, multi-center, single-arm clinical study, in patients with coronary artery disease, including patients with silent ischemia (excluding stemi), who qualify for elective percutaneous coronary intervention (pci), aimed to assess the safety and efficacy of the r-one device in elective pci.


Eligibility criteria:
inclusion criteria: * age ≥18 years; * candidate for pci; * presence of a de novo coronary artery stenosis of ≥ 50% and \<100% in a native coronary artery indicated and suitable for stent implantation; * the vessel has a reference vessel diameter ranging from 2.5 mm to 4.0 mm; * the target lesion length allows for treatment with a single stent up to 38 mm in length; * up to 2 target vessels each with a single target lesion requiring a single stent per lesion and treatable within a single procedure may be included (no further staged procedure allowed); * the patient provides written informed consent as approved by the applicable ethics committee and is willing to comply with all study requirements including 30 days follow-up. exclusion criteria: * target lesion has timi flow \< 3; * treatment of in-stent restenosis, or prior stent in the target vessel proximal to the target lesion; * more than one target lesion per vessel requiring treatment at the time of procedure; * target lesion is a bifurcation requiring balloon or stent implantation of the side branch, with a side-branch rvd of ≥1.5 mm with a ds ≥50% at or within 5 mm its origin, or rvd ≥2.0 mm regardless of the presence of side branch disease; * target lesion is located in left main coronary artery, or any left main stenosis \> 30%; * target lesion is within 5 mm of the ostial lad, ostial lcx or ostial rca; * severe vessel tortuosity; * severe vessel calcification; * stemi, cardiopulmonary resuscitation or cardiogenic shock within 48 hours of the procedure; * presence of visible thrombus; * need for any procedure other than balloon angioplasty or stenting (e.g. atherectomy, laser, are excluded); * patients under judicial protection, tutorship or curatorship (for france only); * any patient participating in another clinical study evaluating a drug or a medical device (except registries for which the primary endpoint has not been evaluated; * pregnant and breast-feeding women or intention to become pregnant prior to completion of all follow-up procedures.

Keywords: coronary artery disease percutaneous coronary intervention
life style, nutrition and oral health in care givers (lento)

Conditions: Nutrition Disorders in Old Age; Caries,Dental; Dentures; Oral Mucositis; Tooth Diseases; Plaque, Dental; Gingival Diseases

Summary: the lento study sample includes the caregivers and their clients living in eastern finland. the aims of this study are 1. to study the nutritional status, oral health, coping, functional capacity and quality of life 2. to find out how individual nutrition and oral health counseling received for caregivers affect on the nutritional status and oral health of caregivers and their clients 3. develop an operating model to maintain good nutrition and oral health.

in finland, the aim is to reduce the institutional care of older people and caring them in their own homes. the goal of shifting the focus of services to open services is difficult to implement if the health of the caregivers is inadequate. in order to achieve this goal, it is important to influence the health and performance of caregivers. information is needed to support this, among others, about how the nutrition and oral health of caregivers can be promoted and to what extent this affects the performance and quality of life of their clients. a randomly of 220 caregivers over 65 years old and their clients is selected for this study. the caregivers are randomized to either treatment or control groups. at the beginning of the study is estimated the nutritional status and oral health of the caregivers. based on the results, the nutritionist and dental hygienist give individual advice to optimize the nutrition and oral health of the caregivers in the intervention group. after six months, the same measurements are made as at the beginning of the study. monitoring measurements will be made one year after the start of the intervention. the results of this project provide information on the health, well-being, and ability to the function of the caregivers. based on the results, is developed an operating model that is intended to be wide as use as possible. improving the nutrition and oral health of caregivers has a significant impact on their own and their clients health and well-being as well as the long-term care costs presumably.

Eligibility criteria:
inclusion criteria: * caregivers who have a caregiver´s contract valid on 1 january 2019 * care recipients living at home exclusion criteria: * in terminal care

Keywords: nutrition oral health care givers home care clients quality of life
hydrolized protein formula for premature infants

Conditions: Prematurity

Summary: premature infants fed with a protein hydrolyzed formula will have better tolerance needing shorter time to achieve full feeds when compared to those fed with an intact protein formula.

the study formula is a 100% whey protein partially hydrolyzed (vs 60/40 whey:casein ratio of regular premature formulas) because the tolerance and availability of breast milk is not predictable at the time of enrollment all the eligible premature infants will be randomized and assigned to the study or control group. infants will receive formula, either because breast milk is not available or because indicated by the attending physician and switched to formula, they will be fed, depending of the group to what they are assigned, with either the ph formula for the study group or regular premature formula for the control group. randomization and blinding all eligible infants with parental consent will be randomized to either the study group to receive protein hydrolyzed formula (ph group) or to the control group to receive standard premature formula. randomization will be stratified by 2 birth weight categories (500-1000 g and 1001-1500 g). the purpose of such stratification is to avoid imbalance between groups for factors that may influence outcome and is based on the different morbidity in different birth weight categories. masked randomization will be performed in a way that avoids the possibility of knowledge of treatment assignment at the time that eligibility is assessed and consent is sought. only the person in charge of preparing the control or study formula will be aware of the infant's assignment group. caregivers will remain masked to treatment group. study population preterm newborns admitted to the neonatal intensive care unit with a birth weight 500-1500 g and who survive more than 3 days.

Eligibility criteria:
inclusion criteria: * birth weight between 500 -1500g and \< 32 weeks ga who survive more than 3 days. * has not yet started enteral full feeds. * study explained and parent/caregiver demonstrating understanding of the given information. * informed consent signed. exclusion criteria: * chromosomal anomalies. * major congenital anomalies (complex cardiac anomalies, congenital hydrocephalus, renal dysplasia). * congenital (e.g. jejunal atresia) and acquired (e.g. gi perforation) gastrointestinal pathology precluding oral feed and/or requiring major surgical or medical intervention. * parental refusal. * prior enrollment into a conflicting clinical trial. conflicting clinical trial will be those in which the intervention could modify the outcome of the present study, for example studies aimed to accelerate feeds and or improve tolerance.

Keywords: feeding intolerance prematurity
responsiveness and validation study of mfm-20 in sma patients treated with nusinersen

Conditions: Spinal Muscular Atrophy

Summary: the motor function measure (mfm), a reliable tool assessing motor function and its progression in most neuromuscular diseases, is widely used in france in many teams. it can be used regardless of the severity of the motor impairment or the ambulatory status of the patient, allowing its use throughout the whole follow-up period of the patient, even in case of the loss of walking. two versions of the mfm exist, one composed of 32 items validated for patients from 6 years old (mfm-32) and a shorter version composed of 20 items validated for patients between 2 and 6 years old (mfm-20). in order to show the possible use of mfm-20 as early as the age of 2 years to validly and reliably monitor the evolution of the motor function of children treated with nusinersen, we propose in this project to study the sensitivity to treatment-induced change of mfm-20 and the validity of the scale in this population.


Eligibility criteria:
inclusion criteria: * boys and girls with type 1 or 2 spinal muscular atrophy, genetically confirmed * aged 2 to 6 years old * treated by nusinersen for at least two months * with at least 3 mfm-20 repeated measures, and with adelay minimum between the first and the last mfm-20 of 6 months * with parental assent exclusion criteria: * - patients with associated cognitive impairment making impossible evaluation of motor function * patients participating to a clinical study with a potential effect on their motor function.

Keywords: spinal muscular atrophy motor function measure outcome assessment nusinersen
coaching lifestyle intervention for fertility

Conditions: Life Style; Fertility Disorders

Summary: in finland, every third woman is overweight (bmi\>25) and 11,5% obese (bmi\>30). cohort and national studies reveal that 46% of fertile-aged men have bmi≥25 and 20% bmi≥30. overweight has negative impact on both female and male fertility and weakens markedly the results of infertility treatments. in this study, 780 infertile couples will be randomized to control group (conventional infertility treatment) and lifestyle intervention arm undergoing 4 sessions of video-mediated motivational interview, anthropometric measurements, laboratory tests and epigenetic samples. economic evaluation of the intervention will also be performed.


Eligibility criteria:
inclusion criteria: * infertility * bmi 27-34.9 kg/m2 exclusion criteria: * no mobile device available * evident sperm defect or ovarian tube block * hinder for fluent treatment schedule due to the subjec´s obstacle (inadequate language skills, major time table problems)

Keywords: infertility life style physical activity diet sleep and stress intervention obesity
biomarkers in patients with suspected hfpef

Conditions: Heart Failure; Obesity; Heart Failure With Preserved Ejection Fraction

Summary: nt-probnp does not adequately identify hf(pef) in people with suspected hf at low levels, particularly in patients with obesity. this study will investigate: 1. alternative cut-offs for nt-probnp to identify hf(pef) in people with suspected hf and obesity 2. novel candidate biomarkers to identify hf(pef) in people with suspected hf and obesity. 3. novel candidate biomarkers to identify hf(pef) in people with suspected hf and nt-probnp \<125 ng/l 4. the prevalence of hf in people with suspected hf and low nt-probnp \<125 ng/l)

this will be a prospective observational, non-randomised study of patients in primary care with suspected hf. detection of hfpef in people without obesity is well-served by nt-probnp. in contrast, nt-probnp does not perform well when used to detect hfpef in populations with obesity. there is increasing evidence that some people with low levels of nt-probnp can have hf. as many as 50% of people with obesity and hfpef (detected by elevated filling pressures) have nt-probnp \<125 ng/l. some patients with hfpef who are not obese can also have low natriuretic peptides levels. delayed diagnosis can lead to adverse outcomes for patients, in particular presentation acutely to secondary care. in addition to this, some patients with hfpef who are not obese can also have low natriuretic peptides levels. patients with ntprobnp levels performed in the community for stable symptoms of suspected heart failure will be invited to participate. assessments in this study will include clinical history and examination, patient-reported outcome measures, electrocardiography, echocardiography and biomarker (blood and urine) analysis. heart failure diagnostic scores and clinical evaluation by heart failure experts will be used to make a clinical diagnosis of heart failure, and to correlate this with levels of plasma and urine biomarkers, both established and novel. patients will be followed up passively (for a minimum of 10 years) using record linkage for subsequent hospitalisations or deaths.

Eligibility criteria:
inclusion criteria: * written informed consent * age ≥ 18 years * nt-probnp sample taken by primary care physician as part of routine care for suspected heart failure exclusion criteria: * unable to consent to inclusion in study due to significant cognitive impairment * geographical/ social reasons preventing attending study centre * unable to complete study assessments * patients presenting with acute hf or a previous diagnosis of hf
protectivity and safety of quadrivalent influenza ha vaccine in indonesian population

Conditions: Safety Issues

Summary: this study is to assess protectivity and safety of quadrivalent influenza vaccine in indonesian population

to describe the protectivity rate of quadrivalent influenza ha vaccine 28 days after immunization in indonesian population. to describe immunogenicity of quadrivalent influenza ha vaccine in all subjects

Eligibility criteria:
inclusion criteria for subjects 9 - 40 years of age: * healthy * properly informed about the study and having signed the informed consent form * subject/parent will commit themselves to comply with the instructions of the investigator and the schedule of the trial. inclusion criteria for subjects 6 months - 8 years of age: * healthy * parents have been informed properly regarding the study and signed the informed consent form * parents will commit themselves to comply with the instructions of the investigator and the schedule of the trial exclusion criteria: * subject concomitantly enrolled or scheduled to be enrolled in another trial * evolving mild, moderate or severe illness, especially infectious diseases or fever (axillary temperature \>= 37.5 c ) * known history of allergy to egg and or chicken protein or any component of the vaccines * history of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection * subject who has received in the previous 4 weeks a treatment likely to alter the immune response (intravenous immunoglobulins, blood-derived products or long term corticotherapy (\> 2 weeks). * pregnancy \& lactation (adult) * any abnormality or chronic disease which according to the investigator might interfere with the assessment of the trial objectives * subject already immunized with influenza vaccine within 1 year. * subjects receive any vaccination within 1 month before and after immunization of quadrivalent influenza vaccine.
efficacy and safety evaluation of changes in lower extremity edema of radiofrequency

Conditions: Idiopathic Edema

Summary: the purpose of this study is to verify the efficacy and safety of the radiofrequency stimulation compared to the sham stimulation in reducing lower extremity edema in adult women with idiopathic edema.

in this study, based on the characteristics of radiofrequency, it was hypothesized that radiofrequency could have an effect on the reduction of lower extremity edema and prevention of fatigue. the occurrence of edema is interpreted as a problem that blood circulation is not smooth due to increased inflow of body fluid, and therefore the degree of edema is also used as an indicator of blood circulation. therefore, in this study, based on the principle that radiofrequency promotes phosphorylation and blood circulation, the purpose of this study is to investigate whether radiofrequency treatment is effective in reducing edema of the lower extremities and changing body heat in the lower extremities compared to the gastric stimulation device through exploratory research.

Eligibility criteria:
inclusion criteria: 1. women between the ages of 19 and 72 2. those who are not likely to menstruate during the trial treatment period (3 days) (females within 8 to 18 days after the onset of menstruation) 3. those who meet the diagnostic criteria for idiopathic edema (mckendry criteria score of 15 or higher) 4. those who show a weight change of 1.4 kg or more between morning and night measurements 5. those who have a difference of 1cm or more from the ankle or 2cm or more from the calf when measuring the circumference in the morning and evening 6. those who voluntarily agree to participate in this clinical trial and sign the consent form exclusion criteria: 1. in the case of using a heart rate control device such as a metallic substance in the human body 2. during menstruation or if there is a possibility of pregnancy 3. if you have heart disease 4. if you have liver or kidney disease 5. if there is bleeding or internal bleeding from wounds or surgery 6. for hypertensive patients 7. for epilepsy patients 8. if you are taking weight loss or health-related drugs/health functional foods 9. in the case where it is judged by the principal investigator that participation in this study is not appropriate