Kornimate/medical-research-clean huggingface dataset:
effectiveness of a school-based obesity prevention program on body fat at 6 months of mexican children

Conditions: Childhood Obesity Pevention

Summary: school-based programs are an essential strategy for preventing obesity, yet the most effective way to implement them remains unclear. this study aims to evaluate the effectiveness of a school-based obesity prevention program, delivered by different implementers, in comparison to a control group, focusing on body fat reduction in mexican children. this is a cluster randomized controlled trial. approximately six public elementary schools (240 children) in hermosillo, mexico, will be invited to participate. schools will be randomly assigned to one of three groups: a program implemented by advanced undergraduate students in nutrition and physical activity (nut-pa), a program implemented by physical education teachers and physical activity students (pest-pa), or a control group. the intervention will consist of a 6-month obesity prevention program that includes nutrition education, physical activity sessions, and parent participation. the control group will continue with their regular school activities. the primary outcome will be the difference in body fat percentage at 6 months between the nut-pa group and the control group, as well as between the pest-pa group and the control group. secondary outcomes will include bmi z-score, waist circumference, and various lifestyle parameters. a mixed-effects linear analysis will be conducted using an intention-to-treat approach.

this is a cluster randomized controlled trial with three parallel groups and a 1:1:1 allocation ratio. the current protocol represents the definitive phase of the study, which was previously registered and approved in clinical trials (nct05461703). the project has been approved by the research ethics committee of the nursing department at the universidad de sonora (epd-007-2022).

Eligibility criteria:
schools inclusion criteria: * school principals, 4th- and 5th- grade teachers willing to participate, availability of space for physical activity classes, and groups with a minimum of 20 students. exclusion criteria: * participating in a similar study. children inclusion criteria: * to be a 4th or 5th grade student (9 to 12 years) in one of the participating schools. to be eligible for this study, parents and children will be required to sign an informed consent and assent form, respectively, and had to complete anthropometric measurements (children) and lifestyle questionnaires (parents). exclusion criteria: * a personal condition that prevents conducting physical activity or a condition that parents consider should exclude their child from participating. implementers inclusion criteria: -received 80% of the program training. satisfactory response to a questionnaire that assessed their knowledge of the program following the training.

Keywords: intervention nutrition physical activity randomized controlled trial body fat school
primary tumor burden score:a novel staging parameter for escc after ncrt

Conditions: Neoplasm, Esophagus; Neoplasm, Squamous Cell

Summary: in this case-only study, the investigators try to define a novel staging parameter, the primary tumor burden score (ptbs).

in this case-only study, the investigators try to define a novel staging parameter, the primary tumor burden score (ptbs), which will combine the proportion of residual primary tumor cells and pre-treatment pathological t stage (prept stage). the investigators will also try to improve yptnm stage by results of ptbs.

Eligibility criteria:
inclusion criteria: - neoadjuvant chemoradiotherapy and surgical resection of esophageal squamous cell carcinoma exclusion criteria: * patients receiving neoadjuvant chemoradiotherapy for esophageal squamous cell carcinoma without surgical resection
mycophenolate mofetil in systemic lupus erythematosus (missile)

Conditions: Systemic Lupus Erythematosus; Atherosclerosis

Summary: systemic lupus erythematosus (sle) is an independent risk factor for atherosclerosis. endothelial dysfunction is the earliest marker of atherosclerosis and is measured by flow mediated dilation (fmd) of the brachial artery. the purpose of the study was to measure fmd in mild, stable sle patients and look for change in fmd with the immunosuppressant drug mycophenolate mofetil (mmf).


Eligibility criteria:
inclusion criteria: * female sle patients * age 18-60 years * if premenopausal using a reliable method of contraception * clinically stable disease * taking hydroxychloroquine and up to 15mgs of prednisolone daily exclusion criteria: * smokers * pregnancy or breast feeding * use of other immunosuppressants (hydroxychloroquine and stable dose of prednisolone up to 15 mgs daily will be permitted) * use of any investigational drug within 1 month prior to screening * acute infections 2 weeks prior to visit 1 * history of ischaemic heart disease or end stage renal disease * current signs or symptoms of severe, progressive or uncontrolled hepatic, haematological, gastroenterological, endocrine, pulmonary, cardiac or neurological disease

Keywords: sle atherosclerosis endothelial function mycophenolate mofetil
effect of using a birth ball on birth satisfaction and pain in pregnant women during labor

Conditions: Pain; Labor Pain; Satisfaction

Summary: h0: there is no difference between birth satisfaction and pain levels of pregnant women who used and did not use a birth ball during labor. h1: there is a difference between birth satisfaction and pain levels of pregnant women who used and did not use a birth ball during the birth process.


Eligibility criteria:
inclusion criteria: * the consent of the pregnant women to participate in the study, * have signed the informed consent form, * be over the age of 18, * vaginal opening was determined as 4 cm exclusion criteria: * having a psychologically diagnosed disorder * pregnant women diagnosed with risky pregnancy

Keywords: birth ball birth satisfaction pain midwifery care
a clinical study of brca and dna damage repair genes in blood samples of chinese pancreatic cancer patients

Conditions: Pancreatic Cancer

Summary: this study aims to know the status of brca and ddr genes in pdac patients in china. peripheral venous blood samples of the patients will be collected for next-generation sequencing of brca and dna damage repair related genes. at the same time, it is necessary to record clinical information such as age, gender, tumor pathological type, tumor stage and grade, whether surgery is performed, the size of postoperative residual lesions, and treatment methods. prognostic indicators include the association of factors such as pfs, orr, and dcr are also recorded.


Eligibility criteria:
inclusion criteria: * patients diagnosed with pancreatic cancer * ps score ≤ 2 * no severe heart, cerebrovascular disease, severe coagulation dysfunction or severe mental disorder exclusion criteria: * ps score \> 2 * with severe heart, cerebrovascular disease, severe coagulation dysfunction or severe mental disorder
cross-over study of three modular devices for aid in patient standing and transfer

Conditions: Mobility Limitation

Summary: the main objective of this study is to evaluate via a physiological analysis of the movements involved in standing, the level of forward flexion of the spine (in cm on the horizontal axis) obtained with the apparatus "tina" and to compare levels obtained in the same patients with stander/transfer devices "turner" and "vertic'easy".

secondary objectives of this study are to compare the three devices in terms of: * the level recovery of the spine on the vertical axis (vertical displacement c7, cm) * standing time, defined by the time between the start of the forward flexion and the beginning of the vertical stabilization phase (seconds) * the success rate of the verticalization of the patient (the attempt is considered successful when the vertical position is held for 10 seconds).

Eligibility criteria:
inclusion criteria: * the patient must have given his/her informed and signed consent * the patient must be insured or beneficiary of a health insurance plan * the patient is in stable medical condition (no complications in the last 10 days) * the patient is unable to stand up by his/her self and requires help during transfers * the patient has muscular force (quadriceps) \> 3 out of 5. exclusion criteria: * the patient is participating in another study * the patient is in an exclusion period determined by a previous study * the patient is under judicial protection, under tutorship or curatorship * the patient refuses to sign the consent * it is impossible to correctly inform the patient * the patient is pregnant, parturient, or breastfeeding * the patient has a limited support from at least one lower limb * the patient has an unstable fracture * the patient has a fragile heart * the patient has joint pain localized in the knee, hip or ankle. * the patient has already used one of three mechanisms to help with standing and transfer used in this study * behavioral problems (opposition, agitation)

Keywords: standing devices transfer devices
randomized,multicentric study to treat prolapse after hysterectomy with amreich procedure or total prolift procedure

Conditions: Pelvic Organ Prolapse

Summary: head to head comparison of perioperative complications and secondary the impact of operation techniques with or without mesh on patients suffering from pelvic organ prolapse on quality of life.

during the last decade a substantial progress in the detailed knowledge of morphology and function of different compartments of the female pelvic floor was achieved. the obtained informations were quickly implemented in the clinical practice especially in the application of special meshes and of novel techniques of their implantation. their success rate was evaluated only in pilot companies supported studies. we do miss randomised studies not sponsored by company comparing different surgical techniques and their impact on the quality of life (qol); the objective estimation of those consequences is for the longlasting effect of the surgery inevitable. the new methods bring also new complications which were not yet relevantly and objectively documented. in the study we compare the techniques contemporary used - in the groups with or without mesh, in size relevant for the statistical evaluation

Eligibility criteria:
inclusion criteria: * female sex * age 18 and more * subscribed informed consent * objective symptoms of prolapse-pop-q 3 and more according to ics standards * compliance of the patient exclusion criteria: * patients with evidence of malignant lesion in small pelvis * history of radiotherapy in small pelvis * patients suffering from any form of pid within inclusion process * pregnancy * lactation * total eversion of uterus and vagina * serious internal disorders * history of recto- or vesico-vaginal fistula * history of rejection of any artificial material * symptoms of primary genuine stress urinary incontinence * patients who were not able to subscribe the informed consent * patients, who couldn´t be reached for further follow-up

Keywords: biocompatible materials female humans pelvic floor polypropylenes prostheses and implants surgical mesh uterine prolapse/*therapy
chronic obstructive pulmonary diseases and proprioceptive neuromuscular facilitation

Conditions: Chronic Obstructive Pulmonary Disease

Summary: to investigate the effects of resistant proprioceptive neuromuscular facilitation exercises on physical fitness, respiratory muscle strength, walking distance and quality of life in chronic obstructive pulmonary patients.

the study was carried out between january 2017 and january 2019, with patients followed up with the diagnosis of copd in çanakkale mehmet akif ersoy state hospital and çanakkale onsekiz mart university medical faculty hospital, department of chest diseases. it was approved by istanbul medipol university non-interventional clinical research ethics committee (date: 30.12.2016, decision no. 573) and was done in accordance with the declaration of helsinki. all participants were informed about the purpose of the study, the total duration of treatment and the applications to be made, and a consent form was signed. the study was conducted as a prospective and randomized controlled study, and inclusion and exclusion criteria were determined. thirty-five patients diagnosed with copd were referred to the study, four patients were excluded because they did not meet the inclusion criteria, and the study was conducted with a total of 31 participants. the 31 patients included in the study were randomized after their initial evaluation and divided into two groups as experimental and control groups. patients meeting the inclusion criteria were divided into 2 groups. randomized by ordering by date of application.

Eligibility criteria:
inclusion criteria: * to be diagnosed with stage 1, stage 2 and stage 3 copd according to gold (global initiative for obstructive lung diseases) criteria * having fev1/fvc \<70% according to pulmonary function test * being clinically stable * being over 18 years old * volunteer to participate in the program exclusion criteria: * having a copd exacerbation in the last 8 weeks * to have participated in a regular exercise training program in the last 1 year * having a musculoskeletal disease and neuromuscular disease that may prevent exercise * inability to cooperate for pulmonary function test and respiratory muscle strength measurement * being on long-term oxygen therapy

Keywords: copd
a study of suboptimally controlled participants previously taking oral or infusion dmds for rms (master-2)

Conditions: Multiple Sclerosis

Summary: to evaluate the effectiveness, safety and patient-reported outcomes (pros) of cladribine tablets in participants with rms including relapsing-remitting multiple sclerosis (rrms) and active secondary progressive multiple sclerosis (aspms), who transition to cladribine tablets after suboptimal response to any oral or infusion disease-modifying drugs (dmds) approved in the united states (us) for rms in a real-world-setting.


Eligibility criteria:
inclusion criteria: * signed informed consent * have diagnosis of rms, including rrms and aspms, and satisfy the approved indication for cladribine tablets as per united states prescribing information (uspi) * have time since diagnosis of rms of at least 12 months * in the opinion of the investigator, experienced suboptimal response (lack of effectiveness, intolerability, poor adherence) to oral or infusion dmd treatment other than cladribine tablets * had received their last previous oral dmd for at least 1 month or at least 1 dose of their last previous infusion dmd * have decided to initiate treatment with cladribine tablets during routine clinical care * meet criteria as per the approved uspi * have access to a valid e-mail address exclusion criteria: * have been previously treated with cladribine in any dosing form (intravenous, subcutaneous, or oral) * transitioning from previous oral dmd solely for administrative reasons such as relocation * have comorbid conditions that preclude participation * have any clinical condition or medical history noted as contraindication on uspi * are currently participating in an interventional clinical trial * pregnant or breastfeeding women, women who plan to become pregnant or men whose partner plans to become pregnant during study the cladribine treatment period

Keywords: multiple sclerosis cladribine tablets observational mavenclad
tdm guided early optimization of adal in crohn's disease

Conditions: Crohn Disease; Drug Monitoring; Inflammatory Bowel Diseases

Summary: to investigate the influence of early therapeutic drug monitoring and dose optimization on disease outcome in crohn's patients treated with adalimumab.

this is an investigator initiated randomized open label study. this study is designed to compare whether increasing the dose of adalimumab based on the level the drug in the blood to a target level early in the treatment course would lead to better outcomes for patients as compared to the standard doses.

Eligibility criteria:
inclusion criteria: * age 18 or older. * crohn's disease diagnosed based on standard objective methodology (clinical, biochemical, endoscopic, histological and radiological correlation). * active disease based on harvey bradshaw index (hbi \>5) and elevated c-reactive protein (crp) (\>normal reference range for local laboratory) or fecal calprotectin (fcp) (\>250 µg/g) * due to commence treatment with adal. exclusion criteria: * severe co-existing cardiopulmonary, hepatic, renal, neurologic, or rheumatologic disease. * history of active hiv, hepatitis b or c infection, * patients with ileostomy/colostomy, ileal-pouch anal anastomosis or severe perianal fistulising disease. * pregnancy * prior exposure to adal

Keywords: ibd crohn adalimumab adal
effect of cabergoline on weight and glucose tolerance

Conditions: Body Weight; Impaired Glucose Tolerance in Obese

Summary: the aim of this study is to determine the efficacy of cabergoline, a long-acting dopamine receptor agonist, on body weight and blood glucose in healthy obese adults. this is a randomized double-blind placebo controlled study. twenty subjects each will be randomly assigned either placebo or cabergoline for 16 weeks. the effect of treatment on body weight and blood glucose and insulin levels will be compared in the treatment versus the placebo arm.


Eligibility criteria:
inclusion criteria: * age 18 - 55 years * bmi 30 -40 exclusion criteria: * diabetes, * clinically significant medical condition, * use of medications that effect blood glucose or body weight
determine the efficacy of closed suction drain after hydrocelectomy. (end trial)

Conditions: Hydrocele of Tunica Vaginalis

Summary: there is no clear consensus regarding the benefits of putting a closed suction drain after eversion of the sac in a hydrocele of the tunica vaginalis testis. our study will find out the benefits if at all of a closed suction drain in hydrocele surgery. the potential complications expected after hydrocelectomy surgery are bleeding, infection, redness, and pain. there is no such trial to date to determine the benefits of putting a closed suction drain after hydrocelectomy surgery.

study objectives: 1. primary: to compare the postoperative complication rates of hematoma, skin edema and surgical site infection after hydrocelectomy, between patients with or without a closed suction drain (csd). 2. secondary: to compare postoperative pain (testalgia) between the two groups of patients. study setting: all patients over 18 years of age attending the outpatient department of general surgery at aiims, bhubaneswar with the diagnosis of idiopathic hydrocele and planned for elective surgery. total sample size = 60 (30 in each arm)

Eligibility criteria:
inclusion criteria: - all patients over 18 years of age diagnosed with primary hydrocele by clinical and ultrasonographic confirmation, undergoing hydrocelectomy surgery. exclusion criteria: * patient not giving consent to participate * patients with asa (american society of anaesthesiology) grade 3 \& 4 * patients with congenital or secondary hydrocele * patients with recurrent disease, pyocele or filarial scrotum

Keywords: hydrocele drain surgery complications hydrocelectomy hematoma infection
canadian humira post marketing observational epidemiological study: assessing effectiveness in ankylosing spondylitis

Conditions: Ankylosing Spondylitis

Summary: the current study will assess the real - life effectiveness of adalimumab in the management of ankylosing spondylitis (as) with emphasis on the prevention and management of extra-articular manifestations.


Eligibility criteria:
inclusion criteria: * adult \>= 18 years old * has provided written informed consent allowing the use of their data for the study and providing permission for contact by the study personnel * active ankylosing spondylitis as per the judgment of the treating physician * inadequate response or non tolerant to current nsaid (nonsteroidal anti-inflammatory drug) or dmard (disease-modifying anti rheumatic drug) based treatment for as exclusion criteria: * currently participating in another prospective study including controlled clinical trials and observational studies * patient cannot or will not sign informed consent * stable disease with adequate tolerance and response to current treatment and no change in treatment is indicated * previous treatment with anti-tnf (tumor necrosis factor) or other biologic agent * presence of other condition that, in the opinion of the treating physician, prohibits the patient from participating in the study or obscures the assessment of the treatment of as

Keywords: assessing effectiveness in ankylosing spondylitis
finding evidence to treat or reassure in appendicitis (fetor)

Conditions: Appendicitis

Summary: acute appendicitis is the most common surgical emergency in childhood. despite access to current diagnostic modalities, diagnosis may be challenging since the child may have difficulty in articulating symptoms. additionally there is a high frequency of atypical presentation and rapid progression. delayed diagnosis in children is reported as being up to 60%. delayed diagnosis \>48hr increases the perforation rate from 21% to 71%. around 20% of children presenting with appendicitis have perforated by the time they come to surgery. appendix perforation is associated with a prolonged hospital stay and increased cost. once perforated, major complication rates increase from 1.2% to 6.4%, median bed stay increases from 2 to 6 days and hospitalisation costs are estimated at us $33,348. conversely, a false positive diagnosis leads to unnecessary surgery in 12%. it has been suggested that only 35% of surgical referrals with possible appendicitis actually need surgery thus impacting on resource use. a reliable test, especially if painless, would be very useful. if positive the child could undergo early appendicectomy in expectation of a reduction in the perforation rate (and, therefore, reduction in hospital stay). if negative the child could be discharged home safely. no adequate biomarker has been identified. technology already exists to detect changes in volatile organic compounds (voc) in gases. voc analysis is already used commercially to identify disease processes in animals and crops. although voc has been previously used to detect human diseases, it has never been used to look for changes in the composition of breath in appendicitis. the investigators hypothesise that the composition of voc's in children with appendicitis will differ from those without. the investigators anticipate these differences will be of diagnostic and prognostic value in clinical practice. the feasibility of collecting breath samples from children with possible appendicitis to allow voc testing has not been examined.


Eligibility criteria:
inclusion criteria: * patients with suspected appendicitis * aged 5 and up to their 16th birthday on arrival to a\&e * patients referred to the paediatric surgical team that have presented to the leeds general infirmary through a\&e, the children's assessment unit, or via direct referral from another team or hospital. * consecutive presentations who can have some or all of voc sampling during working week. exclusion criteria: * patients with known alternative cause of abdominal pain (e.g. known inflammatory bowel disease) * patients who are both admitted and discharged when no researcher is available

Keywords: paediatric