Kornimate/medical-research-clean huggingface dataset:
impact of vitamin b12 supplementation with iron and folic acid on adolescent girls

Conditions: Anaemia

Summary: the study is a clinical trial to assess the effectiveness of vitamin b12 supplementation along with iron folic acid (ifa) in combating anaemia. adolescent anaemic girls will be randomly divided into two groups. * group 1: ifa weekly supplementation along with information, education, communication sessions * group 2: ifa + cyanocobalamin weekly supplementation along with information, education, communication sessions duration of supplementation: 6 months

the study is a randomized clinical trial to be conducted on mild or moderately anaemic adolescent girls (11-18 yrs) in a slum in delhi. anaemic adolescent girls (n=360) will be randomly divided into two groups. group 1(n=180) will be given weekly supplementation of iron (100 mg) and folic acid (500 mcg) for six months, whereas group 2 (n=180) will be given weekly supplementation of iron folic acid and cyanocobalamin (vitamin b12) to assess the impact of vitamin b12 supplementation on reducing the prevalence of anaemia. for first six weeks, 500 mcg/ week of cyanocobalamin will be given , followed by maintenance dose of 15 mcg/ week for rest of 20 weeks. anthropometric measurements and dietary information will be collected besides biochemical analysis. iec sessions will be organized for both the groups.the study hypothesis is that vitamin b12 supplementation along with iron folic acid (ifa) is more effective in reducing the prevalence of anaemia as compared to ifa supplementation alone.

Eligibility criteria:
inclusion criteria: * willingness to participate * unmarried or married (who still reside with their parents, i.e. prior to 'gauna') adolescent girl. exclusion criteria: * severe anaemia * pregnant adolescent girls * medical conditions like tb, cancer etc
high-intensity focused ultrasound in treatment of uterine fibroid

Conditions: Fibroids

Summary: uterine fibroids are common uterine benign neoplasm. they can cause abnormal menstrual bleeding, pelvic discomfort and urinary frequency. although surgical intervention is the definitive treatment, some women prefer to have their uterus preserved. high-intensity focused ultrasound (hifu) therapy is receiving increasing interest in the management of uterine fibroids by inducing focal thermocoagulation of the fibroids. results obtained by various research groups have shown that hifu treatment is safe, effective and is highly acceptable to patients. the main objective of this study is to evaluate the therapeutic efficacy of hifu in the treatment of uterine fibroids. in this proposed study, 20 patients who have symptomatic uterine fibroids who meet the study inclusion criteria will be invited to participate in the study which involves the use of hifu in the management of the fibroid. background information of the patients such as age, body mass index, hormonal (pre- or postmenopausal) status and the presence of chronic medical disease will be collected. subjects will also be asked to complete an eight-item section of a uterine fibroid symptom and quality of life questionnaire (ufs-qol) which evaluate the effect of the fibroid on the quality of life of women.


Eligibility criteria:
inclusion criteria: * age \>40 years old, with no future childbearing plans * age \>30 years old, who has tubal sterilization * significant fibroids symptoms * clinical uterine size less than 20 weeks gestation * dominant fibroid less than 10 cm in diameter without areas of necrosis as judged by contrast mri * no laparotomy scars * women should be able to give consent exclusion criteria: * other pelvic or uncontrolled systemic diseases * confirmed or suspected pregnancy * patients who are contraindicated for mri examination * patients with thick abdominal wall (\>5 cm, as measured by mri) * presence or history of acute pelvic inflammatory disease * history of lower abdominal surgery, known severe pelvic endometriosis and/ or extensive pelvic adhesion * cervical fibroids, subserous or submucous fibroids with pedicle, \<3.5 cm posterior wall fibroid, fibroids suspicious of malignancy (rapidly growing)

Keywords: uterine fibroid
high intensity interval training and rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: the overall objective is to determine whether high intensity interval training (hiit) has potential to improve disease activity scores for rheumatoid arthritis (ra) patients. by reducing inflammation and modifying immune function hiit may offer a substantial paradigm shift in ra care, especially in older persons with ra who experience aging related-immunesenescence, increased systemic inflammation and greater physical inactivity than young persons. prior to embarking on a large scale trial of hiit-induced disease modification, this pilot study aims to demonstrate that hiit can produce measurable responses in disease activity scores and peak vo2in persons undergoing routine pharmacologic treatment for ra.


Eligibility criteria:
inclusion criteria: * seropositive (positive rheumatoid factor or anti-citrullinated protein antibody) or erosions typical of ra on radiographs. * history of fulfilling 2010 acr/eular classification criteria for ra * able to walk on a treadmill * not participating in regular physical exercise (more than 60 minutes of moderate intensity or 30 minutes of vigorous intensity exercise per week) or weight reduction dieting. * no medication changes within the last three months. * willing to forego knee joint injections, regular nsaid use, and use acetaminophen for any necessary analgesia during the course of the intervention. * no current (within the last three weeks) pharmacologic therapy with corticosteroids. exclusion criteria: * coronary artery disease * diabetes mellitus * chronic obstructive pulmonary disease * absolute contra-indications to exercise: recent (\<6 months) acute cardiac event unstable angina, uncontrolled dysrhythmias causing symptoms or hemodynamic compromise, symptomatic aortic stenosis, uncontrolled symptomatic heart failure, acute pulmonary embolus, acute myocarditis or pericarditis, suspected or known dissecting aneurism and acute systemic infection. * other inflammatory arthropathy or myopathy, paget's disease, pigmented villonodular synovitis, joint infection, ochronosis, neuropathic arthropathy, osteochondromatosis, acromegaly, hemochromatosis, wilson's disease, osteonecrosis, knee replacement. * contraindicated medicine: ticlopidine, clopidogrel, dipyridamole, warfarin, heparin, enoxaparin and other blood thinners.

Keywords: high intensity interval training
impact of an intervention program on parenting stress after preterm birth

Conditions: Preterm Birth; Parenting; Mental Health Wellness 1; Parent-Child Relation; Child Development

Summary: the aim of this study was to assess the impact of an early psychological intervention, triadic parent-infant relationship therapy (trt), on parenting stress, parental mental health, and preterm infant development in the motor, cognitive, emotional and behavioral domains at a corrected age of 18 months.

due to prematurity induced infant-mother separation at birth, sometimes for several weeks, and owing to the concerns it generates, preterm birth exposes the parent-child attachment link to disturbances, especially the mother-child attachment after discharge. several psychological factors affect infant (distress, dysmaturity ) and parents (psychological pain). these can cause lasting parent-child interactions disruption and jeopardize the attachment process. these early link distortions may hinder the infant's behavioral-emotional and cognitive development. prematurity psychological consequences may negatively influence biomedical risks. understanding these premature infants' future development modalities and support involves taking into account intricate organic and psychological factors - which may be combined as well. post-hospital psychological intervention with the family, focusing on parental mental health and triadic parent-infant relationship, proves an essential element in these children care, whose birth conditions were painful.

Eligibility criteria:
inclusion criteria: * enrolled preterm infant were required to be between 28 and 35 weeks gestational age +6 days * enrolled the parents were required to be french speakers, over 18 years old and residing within 50-kilometres radius of hospital exclusion criteria: * preterm infant without congenital anomalies or any other foreseeable disabilities during the neonatal period * parents without known psychiatric history

Keywords: intervention program parenting stress parental mental health preterm infant's development
emphysema and flna mutation

Conditions: Emphysema

Summary: some sparse scientific data support the hypothesis that otherwise unexplained emphysema may be associated with flna mutation. this prospective, monocentric, cross-sectional study aimed to describe the frequency of emphysema in patients carrying an flna mutation. patients with flna mutations who accept the study will benefit from a chest physician's clinical examination, respiratory function tests and a chest scan. the primary endpoint is to describe emphysema's frequency in patients carrying flna mutation. the other objectives are to describe emphysema's features in these patients and to describe their lung function abnormalities. the final goal is to confirm the association between unexplained emphysema and flna mutation.


Eligibility criteria:
inclusion criteria: * patients with an flna mutation (or gene alteration) * patient who has given written consent to participate in the trial * socially insured patient * patient willing to comply with all study procedures and duration exclusion criteria: * patient refused or unable to give informed consent * administrative reasons: inability to receive information, inability to participate in the entire study, lack of coverage by the social security system, * pregnant or breastfeeding women * patient under guardianship * persons deprived of liberty

Keywords: emphysema lung function filamin a
fitmore hip stem pmcf study: a multi-centre, non-comparative, prospective post-market clinical follow-up study.

Conditions: Osteoarthritis; Avascular Necrosis; Rheumatoid Arthritis; Prosthesis Failure

Summary: a multi-centre, non-comparative, prospective post-market clinical follow-up study to obtain survival, clinical and radiographic outcomes data on the zimmer fitmore hip stem.

the objective of this post market surveillance study is to obtain outcome data on the fitmore hip stem by analysis of standard scoring systems, radiographs and adverse event records, and thus to assess the long-term performance and safety of this implant. the fitmore hip stem is a short and curved uncemented stem that allows preservation of the greater trochanter and of the gluteal muscles. indication/target population: patients suffering from severe hip pain and disability requiring total hip arthroplasty. study design: a multi-centre, non-comparative, prospective post-marketing study. targeted number of subjects: 500. data collection: collection of preoperative, intra-operative and immediate post-operative data; follow-up visits at 6-12 weeks, 1, 2, 3, 5, 7 and 10 years post-operatively. recruitment period: 24 months. clinical assessments: evaluations will be made using the harris hip score, the oxford hip score, the sf-12 physical and mental health summary measures, the eq-5d (euroqol) and radiographically. safety assessments: safety will be assessed by appropriate recording and reporting of adverse events throughout the study. the fitmore hip stem is ce marked, commercially available and has been pre-clinically tested.

Eligibility criteria:
inclusion criteria: * patients who are capable of understanding the doctor"s explanations, following his instructions and who are able to participate in the follow-up program. * patients who have given written consent to take part in the study by signing the "patient consent form". * 18 years minimum. * male and female. * patients suffering from severe hip pain and disability requiring hip surgery or as indicated in the treatment of a fracture. exclusion criteria: * patients who are unwilling or unable to give consent or to comply with the follow-up program. * pregnancy. * patients who are skeletally immature.

Keywords: total hip arthroplasty fitmore minimal invasive surgery short stem
evaluation of the safety and usability of the mak exoskeleton in patients with stroke

Conditions: Stroke; Gait, Hemiplegic

Summary: this study aims to evaluate the safety and usability of a motorized mobility assistance exoskeleton (mak). the procedure explores the use of the mak exoskeleton during the static and dynamic rehabilitation sessions with the intention to evaluate the safety and usability of the device in the studied population. the protocol has been focused on defining how the device can be used appropriately in this population in a safe manner by rehabilitation specialists.the study also aims to assess the safety of clinicians implementing the intervention, as well as possible benefits derived from the use of the device. as a secondary outcome, efficacy measurements will be collected.


Eligibility criteria:
inclusion criteria: * age between 18 and 85 years * weight \< 100 kg * height between 1.5 and 1.9 meters * anthropometric measurements to fit in the exoskeleton: * distance from the center of the knee joint to the ground: 42 - 55 cm * distance from the center of the knee to the groin fold: more than 28 cm. * perimeter in thigh (midpoint trochanter - epicondyle): 40 - 63 cm. * perimeter in calf (point of greater volume): 30 - 44 cm. * ability to follow simple commands and communicate basic needs * presence of unilateral hemiparesis * diagnosis of stroke confirmed with imaging tests. * sub-acute or chronic patients (time since diagnosis 1 month or more) * score on fac scale from 1 to 4 * sufficient postural control to maintain standing posture and to take a step with the weight on the affected lower limb, manual assistance or technical aids being allowed exclusion criteria: * spasticity \> 3 in lower limbs according to the mas scale * skin alterations in the contact areas with the exoskeleton * planned surgical intervention during the duration of the study * two or more osteoporotic fractures in the lower limbs in the last 2 years * presence of other pathologies that cause exercise intolerance (such as uncontrolled hypertension, coronary artery disease, arrhythmia, congestive heart failure, parkinson's, severe lung disease) * surgical operation in the 3 months prior to the start of the study on the lower limbs

Keywords: exoskeleton robotic device gait assistance
rhythmia vs carto in redo ablation procedures for atrial fibrillation

Conditions: Paroxysmal Atrial Fibrillation

Summary: the map-af study will compare rhythmia vs carto in redo ablation of paroxysmal af with assessment of both acute procedural profiles and clinical outcomes.

pulmonary venous conduction recovery is found in most patients undergoing redo ablation procedures for atrial fibrillation (af). identifying gaps in prior ablation lines is essential to achieve successful outcomes. high density mapping systems have been proposed to allow the identification of such gaps with speed and accuracy. the map-af study will compare rhythmia vs carto in redo ablation of paroxysmal af with assessment of both acute procedural profiles and clinical outcomes.

Eligibility criteria:
inclusion criteria: * adult patients (18-90 years of age) undergoing redo ablation procedures for paroxysmal af regardless of the systems or energy sources used during the pre-study ablation procedure(s). * paroxysmal af: defined as af terminating within 7 days of onset either spontaneously or with electrical or medical cardioversion. exclusion criteria: * persistent af * prior cardiac surgery * patients with only afl or at as the documented recurrent arrhythmia after the pre-study af ablation(s).
comparative effectiveness of peripheral nerve blocks for outpatient shoulder surgery

Conditions: Postoperative Complications

Summary: this retrospective, population-based cohort study will evaluate the comparative effectiveness of peripheral nerve blocks on patient outcomes after ambulatory shoulder surgery in adults patients undergoing surgery in ottawa, ontario.

the investigators will use a coarsened exact matching algorithm prior to the analysis to minimize bias in this observational study. a multivariate logistic regression model will be used to compare the effect of anesthesia interventions on the primary outcome within matched cohorts. sensitivity analyses will be used to evaluate the robustness of the primary analysis.

Eligibility criteria:
inclusion criteria: * ontario residents * aged 18 years and older * elective ambulatory shoulder surgery exclusion criteria: * emergency surgery

Keywords: unplanned admissions visits to the ed readmissions death
weight loss and physical activity in overweight/obese individuals with knee osteoarthritis

Conditions: Osteoarthritis, Knee

Summary: this is a substudy to a randomised trial investigating the effect of liraglutide on body weight and pain in overweight or obese patients with knee osteoarthritis (nct02905864). in the parent trial, patients will be subjected to an 8-week diet intervention phase including a low-calorie diet and dietetic counselling, after which.they will be randomised to receive either liraglutide 3 mg or liraglutide 3 mg placebo as an add-on to dietetic guidance on re-introducing regular foods and a focus on continued motivation to engage in a healthy lifestyle. this substudy aims to investigate any changes in physical activity associated with the initial 8-week weight loss intervention.

the investigators aim to describe changes in physical activity associated with a significant weight loss among overweight/obese individuals with knee oa. the investigators will take advantage of the planned trial "effect of liraglutide on body weight and pain in overweight patients with knee osteoarthritis: a randomised, double blind, placebo-controlled, parallel group, single-centre trial" (the parent trial) in which a significant weight loss is sought achieved over 8 weeks by means of intensive dietary counseling and meal replacement in overweight/obese individuals with knee oa. the investigators hypothesize that weight loss is associated with a decrease in daily time spent physically inactive. physical activity is measured using accelerometer based recordings using a wearable sensor that continuously records physical activity over the entire weight loss program (8 weeks). the sensor is miniaturised, discretely worn on the thigh, and is waterproof. thus the measurements interfere minimally with the participants daily life.

Eligibility criteria:
further inclusion criteria: * eligible for parent trial (nct02905864) * owner of a smart phone exclusion criteria: * known allergies against band-aids the eligibility criteria for this sub-study (i.e. owner of a smartphone and no known allergies against band-aids) are not considered requirements for participation in the parent study. nor will any violation of this sub-study protocol affect participation, care, or attention given from the parent study.
glucose-stimulated gut lipid release

Conditions: Hyperlipidemias

Summary: during dietary fat absorption, the gut packages the majority of the fats into lipid particles that are secreted into blood circulation. the gut is also capable of storing a considerable amount of fats that can be released at a later time upon receiving certain stimulus signals. one of the signals is glucose ingestion. this protocol examines how glucose ingestion releases gut lipid store. participants drink a fatty formula and 5-9 hours later drink either a glucose solution or water (as control). one hour later, duodenal biopsy specimen are taken for analysis of lipid stores in the gut cells.

participants undergoing upper gastrointestinal endoscopy and duodenal biopsy for clinical indications are recruited after obtaining informed consent. they first have a high fat liquid formula. 5 to 9 hours later, half of the participants drink 50 grams of glucose in 50 ml of water. the other half drink 50 ml of water. 1 hour later, duodenal biopsy specimen are collected and stored for analysis of lipid stores in the gut using electron microscopy and proteins using proteomics.

Eligibility criteria:
inclusion criteria: * men and women, aged 18 to 60 years requiring endoscopy and duodenal biopsies for clinical indications, with no contraindications to the procedure, as judged by endoscopy doctor. * body mass index 20 to 27 kg/m2 exclusion criteria: * patients with active inflammatory bowel disease * patients with celiac disease, exocrine pancreatic insufficiency or small bowel malabsorption * patients with active bowel malignancy * patients with diabetes mellitus or known/ suspected motility disorders of the gut * patients with decompensated liver disease * patients on ezetimibe or bile acid sequestrants * unstable cardiac or respiratory disease * any changes to medication in the preceding month
prospective study of lens performance of a monthly replacement lens at two weeks and four weeks

Conditions: Myopia; Astigmatism; Presbyopia

Summary: the purpose of this study is to compare the overall performance of a monthly replacement contact lens when worn for one month and when worn for two weeks.


Eligibility criteria:
inclusion criteria: * habitual and successful wearers of contact lenses made of lotrafilcon b material for at least 4 weeks prior to enrollment. * good general health. * sphere requirement in the range +6.00 to -10.00 with astigmatism or multifocal correction or no astigmatism or multifocal correction. * ability to comply with all protocol-mandated procedures and to attend all scheduled office visits. * other protocol-defined inclusion criteria may apply. exclusion criteria: * anterior segment abnormalities (i.e., cataracts, opacities, etc.) or active anterior segment disease. * administration of any investigational drug or device within 14 days of study initiation. * use of any eye drops with a pharmacological effect within 7 days of visit 1. * known local or systemic hypersensitivity to contact lens cleaning and disinfecting solutions. * post-refractive surgery. * currently pregnant or lactating by case history. * other protocol-defined exclusion criteria may apply.