Kornimate/medical-research-clean huggingface dataset:
mechanisms underlying peanut allergic reactions in trace peanut study participants: extension study

Conditions: Food Hypersensitivity; Peanut Hypersensitivity

Summary: food allergy affects up to 10% of the population. the mainstay of management involves dietary avoidance and provision of rescue medication in the event of an accidental reaction. the integrated approaches to food allergen and allergy management (ifaam) collaboration is an eu-funded academic/clinical/industry consortium with the aim to improve allergen risk management including food labelling. much of this work requires the validation of the minimum 'eliciting dose' for the food-allergic population and how this can be translated into risk management. a number of studies (including ifaam and the trace study - nct01429896) have assessed the eliciting dose for peanut allergic patients, using food challenges where peanut-allergic individuals are eat incremental doses of peanut under strict medical supervision. in this extension study, peanut-allergic subjects will have undergone (in a cross-over manner) three double-blind, placebo-controlled food challenges to peanut: 1. incremental doses of peanut in a water-continuous matrix; 2. incremental doses of peanut baked into a cookie biscuit; 3. a single dose of peanut in a water-continuous matrix. the differences in eliciting dose, symptom pattern and underlying physiological mechanisms will provide essential data on how the presentation and consumption of peanut affects the amount needed to trigger an allergic reaction, to inform industry and food regulators as to how to best protect the food-allergic population.


Eligibility criteria:
inclusion criteria: * written informed consent. * male and female participants in the trace study (nct01429896) who are 18-45 years of age at the time of entry to the trace study (visit 1) and had a positive dbpcfc to peanut at baseline (visit 1). exclusion criteria * unable to comply with study procedures

Keywords: peanut allergy food allergy thresholds anaphylaxis
treatment of moderate to severe coronavirus disease (covid-19) in hospitalized patients

Conditions: COVID-19

Summary: investigational medications adjunct to clinical standard of care treatment will be assessed to evaluate safety and effectiveness as an anti-covid-19 treatment. all hospitalized persons with moderate to severe covid-19 disease that meet eligibility criteria will be offered participation.


Eligibility criteria:
inclusion criteria: * 18 years or older * moderate to severe covid-19 associated disease as defined by the who * willing and able to provide informed consent prior to performing study procedures * has laboratory-confirmed sars-cov-2 infection as determined by pcr, or other commercial or public health assay * illness of any duration, and at least one of the following: radiographic infiltrates by imaging (chest x-ray, ct scan, etc.), or clinical assessment (evidence of rales/crackles on exam) and spo2 ≤ 94% on room air, or require mechanical ventilation and/or supplemental oxygen. * normal potassium, magnesium, and calcium levels pre-therapy when used in agents at risk of qt prolongation patients will be further distinguished based on their disease severity into one of two categories: * moderate and severe, not critical disease: patients with spo2 ≤ 94% on room air, and those who require supplemental oxygen * severe, critical disease: patients with critical illness requiring icu-level care including requiring mechanical ventilation or ecmo, and/or end organ dysfunction as seen in sepsis/septic shock. exclusion criteria: * alanine aminotransferase (alt) or aspartate aminotransferase (ast) \> 5 x upper limit of normal (uln) * consideration by the investigator, for any reason, that the subject is an unsuitable candidate to receive study treatment medication specific exclusion baricitinib: 1. contraindicated for patients with known hypersensitivity to baricitinib or to any of the excipients. 2. prior untreated latent tuberculosis 3. any individuals with tb risk factors will not be enrolled in the baricitinib arm of the study. 4. presence of active viral hepatitis c or b 5. people with a clinical history of invasive or active fungal infection 6. people with a clinical history of active cmv disease in the last year 7. patients who are pregnant or breastfeeding 8. stage 4 severe chronic kidney disease or requiring dialysis (i.e. egfr \<15) tocilizumab: 1. known hypersensitivity to tocilizumab or any of its components 2. prior untreated latent tuberculosis 3. any individuals with tb risk factors will not be enrolled in the tocilizumab arm of the study. 4. presence of active viral hepatitis c or b 5. people with a clinical history of invasive or active fungal infection 6. people with a clinical history of active cmv disease in the last year 7. crp\<75 mg/l 8. spo2 ≥ 92% on room air remdesivir: 1. known hypersensitivity to remdesivir or any of its components 2. weight below 40 kg 3. spo2 ≥ 94% on room air 4. stage 4 severe chronic kidney disease or requiring dialysis (i.e. egfr \<30)

Keywords: covid coronavirus sars-cov-2
anal canal functional assessment using endoflip

Conditions: Faecal Incontinence; Asymptomatic Condition

Summary: faecal incontinence (fi) is characterized by involuntary loss of rectal content through the anal canal. fi is psychologically and socially debilitating problem that can dramatically affect patient's quality of life, often in otherwise healthy individual. fi can occur as a result of obstetric sphincter injury, surgery, irradiation, anorectal malformations as well as neurological, connective tissue or endocrine disorders. currently management options for these patients are limited, partly due to the fact that control of defaecation and continence is multifactorial but also due to the fact that fi is difficult to identify the exact cause of patients' incontinence. current assessment of patients with fi include endoscopic assessment to rule out intraluminal organic cause for patients' symptoms, endoanal ultrasound scan / mri to assess their pelvic floor anatomy and anorectal manometry to assess anorectal function. anorectal manometry is a simple test to perform but anorectal manometry is susceptible to measurement artifacts, with a high inter-individual variation with significant overlap between healthy asymptomatic and symptomatic patients with fi. harris et al in 1966 suggested that the anal sphincter's resistance to distension that may be of importance for sphincter competence, not how tight anal sphincter can squeeze. endoluminal functional lumen imaging probe (endoflip©) is a novel technology used to measure the dimensions and function of a hollow organ. limited publication so far has shown that endoflip© provides a new way of assessing anal sphincter competence. the study is to assess the use of endoflip© to assess anal sphincter function in hong kong population. firstly to evaluate whether age has an effect on the distensibility of the anal sphincter and its function and secondly to compare between symptomatic patients with faecal incontinence and asymptomatic healthy subjects.


Eligibility criteria:
for asymptomatic group: inclusion criteria: adults over 30 with no history of faecal incontinence, who are able to give consent. exclusion criteria: patients with history of gastrointestinal disease on medication or neurological disorder with bowel symptoms, anorectal surgery or previous bowel resection. patients who are not willing to undergo the specified tests in this study. pregnant women. for faecally incontinent group: inclusion criteria: adults over 30 with history of faecal incontinence for over 3months, who are able to give consent. exclusion criteria: patients who are not willing to undergo the specified tests in this study. pregnant women and patients who has had anorectal surgery or bowel resection.

Keywords: faecal incontinence functional lumen imaging probe anal distensibility
fsh doser for controlled ovarian stimulation

Conditions: Infertility

Summary: the study aims to evaluate the effectiveness of an individualized fsh dosing model called idoser in controlled ovarian stimulation (cos) for assisted reproduction. the randomized, controlled, multicenter trial involves 236 first cycle ivf patients, who will be assigned to either the intervention arm (using the idoser model) or the control arm (standard clinician-determined dosing). the primary outcome is the number of mature oocytes retrieved, with the hypothesis of non-inferiority for the intervention arm. secondary outcomes include cycle cancellations, risk of ovarian hyperstimulation syndrome (ohss), and pregnancy and live birth rates.


Eligibility criteria:
inclusion criteria: * first ivf cycles * use of autologous oocytes * use of fsh on the first day of stimulation (which can be combined with luteinizing hormone, lh). exclusion criteria: * natural ovarian stimulation cycles (without controlled ovarian stimulation) * cycles where fsh is not measured in international units (iu).

Keywords: controlled ovarian stimulation follicle stimulating hormone ai
therapeutic peri-implant maintenance with laser therapy

Conditions: Peri-Implantitis

Summary: the present study represents an extension of the previously concluded randomized clinical trial "laser-assisted regenerative surgical therapy for peri-implantitis" (hum00124386). the aim of the study is to compare the adjunctive effect of laser over mechanical debridement alone in the maintenance of peri-implant tissues after surgical treatment of peri-implantitis (gum disease around implants).

the same 24 subjects, previously treated with surgical regenerative treatment of peri-implantitis following the larst protocol, will be invited to return for three follow-up visits. during the follow-up visits, clinical measurements, x-rays, and pictures of the inside of their mouth will be taken to evaluate the success of their peri-implantitis treatment. if needed, additional laser treatment of the dental implant may also be provided according to the same randomization of subjects in the original study. no placebo laser application will be provided.

Eligibility criteria:
inclusion criteria: * subjects who were previously enrolled subjects in the randomized clinical trial of laser-assisted regenerative surgical therapy exclusion criteria: * unable to reach the subject * the implant is mobile or lost premature exclusion criteria: * the researcher believes that it is not the best interest of the subject to stay in the study * if the subject becomes ineligible to participate based on the exclusion criteria * if the subject's medical condition requires interventions which preclude involvement in the study (radiation therapy, chemotherapy, etc.) * if the subject does not follow study related instructions * the study is suspended or canceled.

Keywords: laser
compressive myofascial release in knee osteoarthritis

Conditions: Osteoarthritis, Knee

Summary: the purpose of the study is to compare the effects of compressive myofascial release and conventional knee osteoarthritis treatment to correct lateral patellar tracking. a randomized control trial was conducted at railway general hospital, ahad medicare clinics and physiotherapy centre and the health professional physiotherapy clinic bahria town phase 6. the sample size was 52 calculated through open-epi tool. the participants were divided into two interventional groups each having 26 participants. the study duration was six months. sampling technique applied was non probability convenient sampling for recruitment and group randomization using sealed enveloped method. only participants who were 50 years above with grade 2 and 3 knee osteoarthritis were included in the study. tools used in this study are q angle, numeric pain rating scale, goniometry and womac questionnaire, self structured questionnaire. data was collected at baseline, at the end of 3rd session and 6th session. data analyzed through spss version 23.

knee osteoarthritis is commonly manifested as decreased joint space, sub chondral bone sclerosis, bony spur formation, cartilage loss and mainly lateral patellar tracking(2).lateral patellar tracking is a condition in which patellar move laterally in relation to femoral groove on flexion and extension(4). patellofemoral disorders are very common in patients of knee oa. one of the very common manifestation of which is lateral patellar tracking(5). patella move laterally due to certain disorders of knee that include patellofemoral pain syndrome and anterior knee pain. q-angle is used as an indicator of patellofemoral pain syndrome. when q angle exceeds its normal limit i.e. 15-20 degrees it leads to lateral mal positioning of patella(6). rozenfeld, e et al. in 2019 conducted a cross sectional study with a diagnosis of anterior knee pain that suggests highest prevalence of myofascial trigger points in distal vastus lateralis and mid and distal vastus lateralis. it also reported that presence of trigger points in anterior knee pain(7). there are several techniques that are used to release trigger points.

Eligibility criteria:
inclusion criteria: * includes diagnosed cases of knee osteoarthritis * grades 2-3 according to the kellgren and lawrence method of grading(1) * includes patients from the age group of 50 years and above(3) * includes knee osteoarthritis patients with lateral tracking of patella which will assessed through q angle test(4) exclusion criteria: * history of recent trauma to knee * history of hip disease * past history of knee surgery/arthroplasty * intraarticular corticosteroid injection

Keywords: knee osteoarthritis compressive myofascial release lateral patellar tracking
information needs after surgery for colorectal cancer

Conditions: Colorectal Cancer

Summary: aim the overall aim was to investigate information needs after surgery for colorectal cancer and factors explaining information needs, both from the patients' perspective and the next of kin's.

sample inclusion criteria are patients over 18 years of age that have gone through a surgery for colorectal cancer without having a stoma, and their next of kin with whom they live. instruments in study i, 100 patients filled in four different instruments 1-2 weeks after discharge to measure: qol, information needs, sense of coherence and performance status. qlq-c30 and qlq-cr38 were used to measure qol. info26 were used to measure received information. the soc - sense of coherence was used to measure sense of coherence. and finally the scale for ecog performance status was used to measure the level of physical performance status. in study ii the same patients filled in the same instruments a second time, 5-7 week after discharge. information about marital status, occupation, diagnosis and prognosis were taken from the medical record. interviews in study iii 16 patients both filled in the instruments in study i and ii, and were interviewed to gain a deeper understanding of their information needs. the interviews were semi structured and will be analysed with content analysis. in study iv the next of kin to patients in study iii were interviewed about their own information needs in connection to discharge. the interviews were performed twice for each person, 1-2 weeks after discharge and a second time, 5-7 week after discharge. data sampling the data were collected consecutively, and every third patient living together with their next of kin were asked to participate in the interviews.

Eligibility criteria:
inclusion criteria: * adult over 18 years of age * surgery for colorectal cancer in one of the three hospitals in the study * speak and read swedish * be able to understand the instructions written in the questionnaires exclusion criteria: * receiving a stoma * don't want to participate * not completed at least half of the items in both questionnaires

Keywords: patient education. patient discharge. needs assessment.
effects of catheter ablation on burden of atrial fibrillation (mriceman)

Conditions: Atrial Fibrillation

Summary: the study will assess the atrial fibrillation burden recorded by implantable loop recorder at 12 and 24 months compared to baseline. the patients with clinical indication fo catheter ablation of paroxysmal atrial fibrillation will be randomized to three techniques: manual radiofrequency ablation, radiofrequency ablation using remote magnet monitoring, and cryoablation.

a total of 300 patients will be randomized to three different catheter ablation techniques (100 patients/group); radiofrequency ablation using remote magnet navigation, radiofrequency ablation using manual method, and cryoablation. a loop recorder (reveal) is implanted one month before the catheter ablation of paroxysmal atrial fibrillation and the effects of atrial fibrillation burden will be compared between the three methods at 12 and 24 months after ablation excluding the first three months´ blanking period. the primary endpoints are: 1. the proportion of patients remaining free from atrial fibrillation, atrial flutter or atrial tachycardia (\> 2 minutes) recorded by the implantable cardiac monitor (medtronic) at 24 months follow-up and 2. total atrial fibrillation burden recorded by the loop recorder. other endpoints: 1. atrial fibrillation burden in 7 days holter recording at 12 and 24 months compared to baseline, 2. the time to first documented symptomatic and asymptomatic recurrence of atrial fibrillation 3. prescription of antiarrhythmic drugs after the 3 months blanking period following the ablation 4. re-ablation after the index ablation procedure, 5. total procedural duration; 6. total time of fluoroscopy and radiation dose; 7. number and duration of cardiovascular hospitalization; 8. quality of life questionnaires at 12 months and 24 month compared with baseline, 9. cognitive function at 12 and 24 month compared with baseline, 10. cost-efficacy of the different ablation techniques.

Eligibility criteria:
inclusion criteria: * patients with symptomatic paroxysmal atrial fibrillation fulfilling the contemporary guideline criteria for af ablation exclusion criteria: - any contraindication to catheter ablation

Keywords: arrhythmias, quality of life
observational study to collect safety data and proms on primary tha

Conditions: Hip Arthritis; Osteoarthritis, Hip; Coxitis; Femoral Head Necrosis; Femoral Neck Fractures

Summary: this observational study is designed to collect safety data and proms on retrospective primary total hipa arthroplasty surgeries with trinity cup and meije duo cementless hip system

the major goal of this study is to collect safety and patient-reported outcomes measures (proms) data on trinity cup in combination with meije duo cementless hip stem when used in primary total hip arthroplasty (tha). data collected from this study will be fed into the post-market surveillance (pms) and clinical evaluation processes of the devices under assessment annually and support presentations at orthopaedic congresses and/or peer-reviewed publication(s) on mid- and long-term safety and clinical performance.

Eligibility criteria:
inclusion criteria: * both genders. * adult subjects. * subjects who received a primary thr with trinity cup and meije duo cementless femoral stem. * the subject is willing to comply with the required follow-up visits as per protocol. * the subject has signed a patient informed consent form (picf), specific to this study, and approved by the local ec. exclusion criteria: * subjects under guardianship. * subjects in the opinion of the investigator/ investigative team who will be unable to comply with study procedures (examples: recent psychotic or mania disorders, alcohol, drug or substance abusers) and/or those unable for any medical or other reason to comply with study procedures/visits.

Keywords: total hip arthroplasty
immuno & reacto of tf trivalent influenza split vaccine 2003/04 or of std formulation influsplit ssw®/fluarix™ 2003/04

Conditions: Influenza

Summary: the aim of the present study is to assess the reactogenicity and immunogenicity of a thiomersal-free influenza vaccine. for comparison, a group of subjects is administered the standard formulation of influsplit ssw® 2003/2004.


Eligibility criteria:
inclusion criteria: * subjects whose parents/guardians the investigator believes can and will comply with the requirements of the protocol * male or female children over 6 months of age at the time of vaccination, but who are not yet 6 years old. * all children included in the study must never have been given a prophylactic influenza inoculation. * written consent to vaccination must be available from both parents or only the single parent after the parents/guardians have been briefed on the study in an understandable language. exclusion criteria: * use of study or unlicensed medication or administration of a vaccine other than the study vaccine within 30 days preceding vaccination and/or during the study period until 30 days after administration of the second vaccine dose. * acute disease at the beginning of the study * acute clinically significant changes in the lungs, cardiovascular system, liver or kidney function, identified by physical examination or laboratory tests. * known allergic reactions that might have been caused by one or more components of the vaccine. * administration of immunoglobulins and/or other blood products within 3 months before the beginning of the study or planned administration during the study period.

Keywords: thiomersal-free influenza split vaccine 2003/2004 influsplit ssw®/fluarix™ 2003/2004 influenza
impact of local biopsy to the endometrium prior to controlled ovarian stimulation on clinical pregnancy

Conditions: Primary or Secondary Infertility

Summary: in vitro fertilization (ivf) is the only available solution for many couples with various forms of infertility. the embryo implantation step in the ivf procedure is a complex multistage process and represents the majority of the causes of the ivf failure. several approaches have been evaluated to improve implantation rates but none has demonstrated its superiority. however, endometrial receptivity is important for pregnancy and several studies suggest that local injury to the endometrium of ivf patients improves the rates of embryo implantation, clinical pregnancy and live birth.

they are possible mechanisms by which endometrial sampling may increase receptivity and improve clinical pregnancy rate of ivf-et. first, local injury to proliferative phase endometrium might induce the decidualization of the endometrium, and increase its implantation rate. second, local injury to the endometrium might provoke the wound healing, involving a mass secretion of different cytokines and growth factor, which are beneficial for embryo implantation. last, the injury might make the endometrium maturation. this study proposes to evaluate the efficiency of an endometrial injury in the first controlled ovarian hyperstimulation cycle on the rate of clinical pregnancy, in assisted reproductive technologies. this study will compare 2 groups of patients. the first group will undergo biopsy of the endometrium before the ivf; the second will undergo the ivf alone. inclusions will be conducted on 33 months; the patients will be in the study for a period of 36 weeks. the total duration of the study is 39 months

Eligibility criteria:
inclusion criteria: * primary or secondary infertility * first or second ivf attempt * aged ≥18 and ≤38 years * regular menstrual cycles * fsh≤ 12iu/l * informed consent signed exclusion criteria: * ovocyte donor * pathology of the uterus or annexes * body mass index (bmi)\> 35 * ongoing vaginal infection * undetermined vaginal bleeding * contraindication to the cornier pipette or to these treatments : gonal f®, puregon®, ovitrelle®, utrogestan®, * women included in another study on medically assisted procreation * any administrative or legal supervision

Keywords: in vitro fertilization biopsy pregnancy implantation embryo first or second ivf tentative