Kornimate/medical-research-clean huggingface dataset:
impact on anxiety of a digital application for children undergoing scheduled ambulatory surgery

Conditions: Anxiety Postoperative

Summary: the prospect of pediatric surgery is a source of preoperative anxiety for children and their parents. it affects 50% of children waiting for surgery and the causes vary according to age. it has been shown that pre-operative anxiety in children often leads to behavioral changes. pre-operative anxiety is often managed by pharmacological premedication. however, there are many alternative techniques to reduce children's anxiety before surgery. the use of an application dedicated to pediatric anesthesia used from the moment of the anesthesia consultation would allow to reduce this anxiety by allowing a varied course of information involving the child in his preparation before the surgery. first, it allows an evaluation of the pre-operative anxiety level of children via validated scales. secondly, it provides information to the children using methods adapted to their age and level of understanding. thus, if this method were validated, other hospitals could use this application to develop a tool that would benefit the many children who undergo surgery each year.


Eligibility criteria:
inclusion criteria : * patients from 3 to 12 years old. * outpatient hospitalization for a scheduled surgery or procedure under general anesthesia. * clinically stable condition. * information note sent to parents and collection of their consent to their child's participation in the study. * parental affiliation to a social security system. exclusion criteria : * urgent intervention situation. * patient included in another study. * no compatible hardware for the application or no internet connection (smartphone, tablet, computer). * patient not affiliated to social security. * mental retardation or psychoactive disorders. * intravenous induction. * need for premedication. * patient who had general anesthesia less than one year ago and/or after the age of 3. * patient who had surgery less than one year ago and/or after the age of 3. * child's refusal.

Keywords: preoperative anxiety ambulatory surgery pediatrics anesthesia digital application postoperative maladaptative behavioral
single-port versus conventional laparoscopic colorectal surgery

Conditions: Colorectal Cancer; Inflammatory Bowel Disease; Benign Colorectal Neoplasm; Diverticular Disease

Summary: conventional multi-port laparoscopic surgery (cl) is now a standard approach to colorectal resections, due to it's short-term benefits over conventional open surgery. in recent years, several studies have demonstrated that - in suitable patients - single-port access surgery (spa) has similar clinical outcome compared to cl, with additional cosmetic benefits. it remains, however, unclear whether the trauma of surgery is also less for spa compared to cl. in this study, the investigators aim to randomise patients who are deemed suitable for spa surgery to either spa approach, or cl; in addition to clinical outcomes including length of operating time, post-operative pain scores, complications, quality of life indicators and cosmetic appearance, the investigators aim to compare the physiological response to trauma through biochemical markers (including c-reactive protein, white blood cell count) and cytokine expression (i.e. interleukins il-6 and il-8). patients will be analysed according to intention-to-treat analysis, with 25 patients in the spa and 25 patients in the cl group. the patients will be operated by surgeons proficient in both cl and spa surgery, and followed-up for the duration of their hospitalisation as well as at their routine out-patient visits, using questionnaires.


Eligibility criteria:
inclusion criteria: * large bowel disorder requiring surgical resection * body habitus suitable for single-port access surgery exclusion criteria: * patients not capable of informed consent and/or quality of life assessment * planned open procedure for surgical reason * multiple previous abdominal operations * body-mass index \> 40

Keywords: single-port access laparoscopic surgery surgical trauma
intraestromal corneal ring in mild keratoconus

Conditions: Cornea; Eye Diseases; Keratoconus; Ophthalmological Disorder

Summary: to determine whether the implantation of an intrastromal corneal ring is an effective treatment for a homogeneous group of mild keratoconus patients.

a group of 65 patients with mild keratoconus were implanted with a ferrara ring in a single eye. six months after surgery, the aberrations were measured and the visual function was determined using clinical indices. the aberrations, especially comatic aberration (coma), were measured independently.

Eligibility criteria:
inclusion criteria: * investigators used the amsler-krumeich classification and included only patients classified as grade i or ii. exclusion criteria: * investigators excluded patients with central corneal scarring, with other eye disorders, or with previous ocular surgery. we also excluded patients with a history of herpes infection, keratitis, corneal dystrophies, diagnoses of autoimmune diseases, systemic connective tissue disorders, or acute keratoconus.
double-blind randomized controlled trial comparing suvorexant 20 mg to placebo for treatment of insomnia in cancer survivors

Conditions: Breast Cancer; Insomnia

Summary: investigators propose a double-blind, placebo-controlled trial evaluating the use of the use of suvorexant in breast cancer survivors on selective estrogen receptor modulators or aromatase inhibitors with sleep disturbance to assess the impact on insomnia symptoms and quality of life. breast cancer survivors have an increased risk of insomnia for which suvorexant has the has the potential ability to impact to improve sleep related outcomes and cancer survivorship outcomes. breast cancer survivors with sleep disturbance based on an insomnia severity index score (isi) \>15 will be randomized to either suvorexant or placebo, with both arms receiving education on sleep hygiene.

cancer survivors have an incidence of sleep disturbance and insomnia higher than the general population, with significant potential implications on health outcomes including in survivorship domains and mortality outcomes. available pharmacologic options for management of sleep disturbance are limited in efficacy and in their side effects. investigators propose a double-blind placebo-controlled trial evaluating the use of the use of suvorexant in breast cancer survivors on selective estrogen receptor modulators or aromatase inhibitors with sleep disturbance to assess the impact on insomnia symptoms and quality of life. evaluation of breast cancer survivors on endocrine therapy uses a study population with high 5-year survival rate while retaining the capacity for recruitment and creating an opportunity to explore potential effects on vasomotor symptoms. suvorexant has the potential to have a significant impact in cancer survivors not only on sleep related outcomes but also on cancer survivorship outcomes. the purpose of the research study is to evaluate the ability of suvorexant, a medication approved by the food and drug administration (fda) for insomnia, to treat sleep disturbance in breast cancer survivors on endocrine therapy.

Eligibility criteria:
inclusion criteria: * adult post menopausal breast cancer survivors (female, \> 18 years old) * current selective estrogen modulator or aromatase inhibitor use * at least 6 weeks beyond completion of definitive treatment for breast cancer * less than 5 years from time of diagnosis. exclusion criteria: * less than 6-month life expectancy * current steroid use * severe depression or anxiety * severe hepatic impairment * concurrent use of moderate or strong cyp3a inhibitors * current receipt of hospice care * severe mental illness * current use of greater than 40 morphine milligram equivalents daily * diagnosis of obstructive sleep apnea, narcolepsy or other sleep related illness other than insomnia * pregnancy * treatment with alternate pharmacotherapy for insomnia at the time of trial initiation * menstrual cycle within the past year
dtace-haic combined with bevacizumab and atezolizumab for huge hepatocellular carcinoma

Conditions: Advanced Hepatocellular Carcinoma; Atezolizumab; Bevacizumab; Chemotherapy

Summary: this study intends to evaluate the efficacy and safety of drug-eluting transcatheter arterial embolization-hepatic arterial infusion chemotherapy of oxaliplatin, 5-fluorouracil and leucovorin (dtace-haic) plus bevacizumab and atezolizumab for patients with intermediate-advanced huge hepatocellular carcinoma.

drug-eluting transcatheter arterial embolization (dtace) and hepatic arterial infusion chemotherapy (haic) of oxaliplatin, 5-fluorouracil and leucovorin are effective and safe for hepatocellular carcinoma. atezolizumab + bevacizumab was superior to sorafenib in overall survival in advanced hepatocellular carcinoma. the anti-vegf combined programmed cell death protein-1 legend 1 (pd-l1) inhibitor were effective and tolerable in patients with advanced hepatocellular carcinoma. we aimed to describe the efficacy and safety of locoregional therapy (dtace/haic) combined with bevacizumab and atezolizumab inhibitor in patients with huge hepatocellular carcinoma who can not receive radical therapy.

Eligibility criteria:
inclusion criteria: 1. clinical diagnosis of hcc. 2. age between 18 and 75 years; 3. the maximum tumor size ≥10 cm; 4. intermediate-advanced huge hcc, advanced hcc with pvtt type i-iii 5. limited metastases (≤5). 6. child-pugh class a or b; 7. eastern cooperative group performance status (ecog) score of 0-1; 8. hemoglobin ≥ 8.5 g/dl total bilirubin ≤ 30mmol/l serum albumin ≥ 32 g/l asl and ast ≤ 5 x upper limit of normal serum creatinine ≤ 1.5 x upper limit of normal inr ≤ 1.5 or pt/aptt within normal limits absolute neutrophil count (anc) \>1,500/mm3 9. prothrombin time ≤18s or international normalized ratio \< 1.7. 10. ability to understand the protocol and to agree to and sign a written informed consent document. exclusion criteria: 1. diffuse hcc; 2. extrahepatic metastasis \>5; 3. obstructive pvtt involving mesenteric vena cava (pvtt iv). 4. serious medical comorbidities. 5. evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy 6. untreated or incompletely treated esophageal or gastric varices (assessed with esophagogastroduodenoscopy) with bleeding or high risk of bleeding. 7. eastern cooperative group performance status (ecog) score of ≥2; 8. known or suspected allergy to the investigational agents or any agent given in association with this trial. 9. cardiac ventricular arrhythmias requiring anti-arrhythmic therapy 10. evidence of bleeding diathesis. 11. patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.

Keywords: hepatocellular carcinoma atezolizumab bevacizumab
a new patient reported outcome instrument to assess symptom experience in women with vulvar neoplasms (woman-pro)

Conditions: Women With Vulvar Intraephitelial Neoplasia or Vulvar Cancer

Summary: post-surgery complications in women with vulvar neoplasms (vulvar intraepithelial neoplasia and vulvar cancer) are still high and an instrument assessing patients self-reported post-vulval surgery symptom experiences is missing. the study aims to develop and validate a postoperative instrument to assess symptom experiences in women with vulvar neoplasms. in this mixed-method project 20 patients were interviewed, a woman-pro instrument was developed and content validity was tested by 6 experts and 10 patients. the instrument's psychometric properties and the prevalence of symptoms will be examined in a cross-sectional study in the university hospitals munich, freiburg, berlin, düsseldorf, zurich, basel, berne, and the cantonal hospital st. gallen (n=150). the goal of this project is that symptom assessment becomes a standard component of clinical practice (to promote the early detection and treatment of symptoms) and research.


Eligibility criteria:
inclusion criteria: * above 18 years old * able to read and write german * diagnosed with vulvar neoplasms * treated with vulval surgery during the prior six month exclusion criteria: * cognitive impaired * concurrently under psychiatric treatment or terminally ill
caries risk assessment in egyptian children in mixed dentition stage

Conditions: Caries Risk Assesment

Summary: this study aim to assess the validity of ada caries risk assessment tool on the egyptian children in mixed dentition stage .

dental caries is the most common chronic disease of childhood that causes health problems such as pain and infection in children reducing their quality of life. risk for caries includes physical, biological, environmental, behavioral, and lifestyle-related factors as insufficient fluoride exposure, poor oral hygiene,inappropriate methods of feeding infants, and poorness . risk is a probability that an event will occur. caries risk assessment (cra) is "prediction of future caries based on the diagnosis of current disease by evaluation of risk and protective factors for making evidence-based clinical decisions. individual risk assessment constitutes the cornerstone of the treatment plan for the management of early childhood caries for pediatric patients. caries risk assessment should be included in the treatment plan to facilitate the decision-making process concerning preventive care (both home and office) treatment, recall appointments. an ideal risk assessment model should be inexpensive, easy to use and time efficient with a high degree of accuracy in caries predictive value. american dental association (ada) is a tool for caries risk assessment and management , that when modified to meet the needs of an environment will be of tremendous use in caries risk assessment. the ada's mission is to help dentists succeed and support the advancement of the health of the public.

Eligibility criteria:
inclusion criteria: * children age range from 6 to 12 years. * apparently healthy children. * children affected by dental caries. * parents acceptance for their children's participation in the study. exclusion criteria: * children on long-term medication.
wave: audiovisual stimulation enhances cognitive, mental and physical health in elderly

Conditions: Mild Cognitive Impairment

Summary: the goal of this randomized controlled trial is to 1) carry out a screening of cognitive function, depressive symptoms, agility and functional balance and chronic inflammatory conditions in older adults; 2) analyze the influence of avns on cognitive function, depressive symptoms, agility and functional balance and chronic inflammatory conditions in older adults. the main question it aims to answer is: "does avns have influence on cognitive function, depressive symptoms, agility and functional balance and chronic inflammatory conditions in older adults ". participants will be randomly assigned to a control group or to a intervention group, where they will use avns to see if influences the above mentioned outcomes, compared to the no intervention (control) group.

mild cognitive impairment (mci) can be defined as a pre-dementia symptom and, when associated with aging, characterizes individuals with cognitive decline below the level of dementia. this decline, which can begin as early as 45 years of age, leads to impairments in memory, learning, language, orientation, and executive functions, which are more visible from the sixth decade of life onwards, with a risk of reduced autonomy and independence, and is seen by researchers as the first stage of a process of loss. this loss is progressive, lasting several years and resulting in mci, characterized by objective cognitive loss, which does not yet compromise autonomy but has a conversion rate to dementia of 10% per year. cognitive decline can be accompanied by increased depressive symptoms and decreased functional capacity and is related to inflammatory conditions, described in the literature as "inflammaging". studies with beat stimulation have shown benefits in different important outcomes of cognitive function and depression. thus, audiovisual neurostimulation (avns) is a possible non-pharmacological treatment that might have a direct influence on the brain wave patterns, altered in mci and depression, modulating these specific wave frequencies to functional patterns similar to those found in healthy individuals. having this, it can also influence agility and functional balance and reduce chronic inflammatory conditions.

Eligibility criteria:
inclusion criteria: * know how to read and write exclusion criteria: -

Keywords: cognitive decline depressive symptoms audiovisual stimulation inflammaging older adults
fatigue in people with rheumatoid arthritis- randomized controlled trial

Conditions: Fatigue; Rheumatoid Arthritis

Summary: aim: to study if a person-centered physical therapy intervention program contributes to diminished fatigue in people with rheumatoid arthritis (ra).

the effect of person-centered physical therapy on fatigue related variables in peoples with rheumatoid arthritis- randomized controlled trial aim: to study if a person-centered physical therapy intervention program contributes to diminished fatigue in people with ra. hypothesis: that the person-centered treatment program diminishes fatigue and its consequences on daily life. design: a controlled randomized interventional trial, assessing effectiveness of intervention. methods: selection: seventy persons with diagnosis of ra and fatigue over 50 (0-100) will be recruited from the rheumatology clinic at sahlgrenska university hospital. participants are randomized to an intervention group or a waiting list control group. intervention: the 12-week intervention period begins with an individual person-centered meeting to develop an individualized feasible self-care plan for the participant with extra focus on health-enhancing physical activity, stress management (relaxation exercise training and modified mindfulness techniques) and balance in daily life. a written consent, aiming to increase coherence, is signed. the participants will be asked to keep a journal about their strategies and reflections. follow up meetings and contacts will be planned according to personal preferences. procedure: the participants are invited to a clinical examination before and after the 12-week intervention and at 6-month follow-up, assessing demographic data, disease activity, inflammation parameters, physical capacity and questionnaires of health status in ra. primary outcome are questionnaires of single item- and multidimensional fatigue. analysis: effects of the interventions will be analyzed using non-parametric statistics for between-group changes over time. within-group changes over time will be analyzed for each group. expected results. new knowledge of fatigue is of importance for improvement of overall health of people with ra, as fatigue influences all aspects of their life, both private life and employment, thus decreasing the quality of life.

Eligibility criteria:
inclusion criteria: * aging 20-65 years, disease duration \>3 year, stable pharmacological treatment exclusion criteria: * other serious physical or mental illness, lack of knowledge in swedish language making answering the questionnaires impossible.

Keywords: fatigue rheumatoid arthritis physical therapy person-centred care
extent of breast cancer and the role of pre-operative sonography and mri

Conditions: Ductal Breast Carcinoma In Situ; Stage IA Breast Cancer; Stage IB Breast Cancer; Stage II Breast Cancer

Summary: this clinical trial studies mammography and targeted ultrasound with or without whole-breast ultrasound or contrast-enhanced magnetic resonance imaging (mri) in finding out the extent of disease before surgery in patients with newly diagnosed breast cancer. new diagnostic imaging procedures, such as whole-breast ultrasound or contrast-enhanced mri, may help find out how far breast cancer has spread. it is not yet known whether mammography and targeted ultrasound are more effective with or without whole-breast ultrasound or contrast-enhanced mri in finding out how far breast cancer has spread.

primary objectives: i. to determine how surgical treatment is influenced by the three imaging arms. ii. to compare three imaging arms in terms of accurately measuring the size of the index lesion and the number and location of tumor foci (using surgical pathology as gold standard). secondary objectives: i. in women with dense breasts: to retrospectively compare the accuracy of three imaging arms in measuring the size of the index lesion and the number and location of tumor foci (using surgical pathology as the gold standard). ii. to report the incidence of synchronous contralateral breast cancers detected by the three imaging arms. outline: patients are assigned to 1 of 3 treatment groups. group 1: patients undergo standard of care diagnostic imaging comprising bilateral mammography and targeted breast ultrasound. group 2: patients undergo standard of care diagnostic imaging as in group 1. patients also undergo bilateral whole-breast ultrasound. group 3: patients undergo standard of care diagnostic imaging as in group 1. patients also undergo bilateral breast contrast-enhanced mri. all patients undergo standard of care breast conserving surgery, or mastectomy if the tests indicate a change in the surgical plan.

Eligibility criteria:
inclusion criteria: * competent to provide informed consent * pathologically proven invasive breast cancer or ductal carcinoma in situ (dcis) originally identified clinically or mammographically and diagnosed by percutaneous core biopsy * eligible for breast conserving surgery followed by radiation therapy exclusion criteria: * women with surgical excisional biopsy that diagnosed the breast cancer * women with clinical or mammographic findings where breast conserving surgery is not an option * women that clinically or mammographically have breast cancers that are fixed to skin * women receiving neoadjuvant chemotherapy prior to surgery * women having contraindications to contrast-enhanced (ce)-mri examination (e.g., claustrophobia and allergy to gadolinium)