Kornimate/medical-research-clean huggingface dataset:
impact on drinking behaviour in sixth-grade students through changing the school environment

Conditions: Students of the 6. Grade

Summary: this study evaluates the effect of changes in the range of drinks offered in vending machines in schools on the sugar intake of pupils via drinks.

children and adolescents consume a considerable amount of liquid in the form of sugary drinks. a high sugar diet associated not only with the increase in overweight children, but also with type ii diabetes, cardiovascular disease and cancer. in many schools, cold drink vending machines with different fillings are available offering various sugary drinks. participating schools will be randomised in a ratio of 1:1:1 into three groups. in one intervention group, the vending machines will be re-equipped to contain 60% drinks containing a maximum of 6.7g sugar/100ml, 20% drinks containing more than 6.7g sugar/100ml and 20% water. in the second intervention group, the vending machines offer 80% water, 20% products with a maximum of 6.7g sugar/100ml. in the control group, the range of products offered by the vending machines remains unchanged. information of the students drinking habits, total fluid intake and sugar intake in the form of food and drinks will be collected. in addition, data such as body height, body weight, physical activity and socio-democratic or socio-economic data will be accumulated. the sales figures of the drinks in the vending machines will be recorded and information about the surroundings of the schools (fast food chains, supermarkets, etc.) will be collected. the survey of students and data collection will be repeated three times. in a sub-study, demographic data and the frequency of consumption of sugared beverages and water are collected from 2 focus groups. in addition, participants will complete a questionnaire on general attitudes towards sugary drinks or water, obstacles to and incentives for reducing sugar consumption by liquids or increasing water consumption.

Eligibility criteria:
inclusion criteria: * students in one of the recruited schools * appropriate knowledge of the german language exclusion criteria: * no signed consent of parent and of child
optical coherence tomography in tissue samples from women undergoing mastectomy for the treatment or prevention of breast ductal intraepithelial neoplasia

Conditions: Precancerous Condition

Summary: rationale: new diagnostic procedures, such as optical coherence tomography, may be effective in finding tumor cells. purpose: this clinical trial is studying optical coherence tomography in tissue samples from women undergoing mastectomy for the treatment or prevention of breast ductal intraepithelial neoplasia.

objectives: * to design and construct a portable forward imaging optical coherence tomography (oct) needle probe. * to compare oct imaging of ex-vivo breast tumor tissue sections with histology to form the basis of an image library for in-vivo work. * to initiate development of an oct needle probe that is capable of acquiring core biopsy samples. outline: breast tissue samples are obtained during mastectomy and analyzed ex-vivo by optical coherence tomography (oct) and by histopathological examination. once routine pathological evaluation and tissue sampling are completed, oct imaging is performed using a portable forward imaging needle probe that is inserted through the ducts of the tissue sample. oct images of the surface of the closest margin to the tumor (if present) as well as images of the duct(s) in the nipple areola complex (after dilation) are obtained. images of a cross section of the tumor (after the sample has been sliced by the pathologist) are also obtained. the oct images are then correlated with tissue histology. the images are used to create a correlation histology-oct atlas for the evaluation of subsequent images and for future reference.

Eligibility criteria:
disease characteristics: * undergoing mastectomy at the city of hope breast center for the treatment or prevention of breast ductal intraepithelial neoplasia patient characteristics: * fertile and/or pregnant patients allowed prior concurrent therapy: * see disease characteristics

Keywords: ductal intraepithelial neoplasia
the pharmacokinetics of rocaltrol when administered alone or in combination with fosrenol or renvela in healthy volunteers

Conditions: Healthy

Summary: to assess the effects of lanthanum carbonate (fosrenol) or sevelamer carbonate (renvela) on the pharmacokinetics of oral calcitriol (rocaltrol)


Eligibility criteria:
inclusion criteria * healthy volunteers age 19-45 years inclusive at the time of consent. * satisfactory medical assessment with no clinically significant or relevant abnormalities in medical history, physical examination, vital signs, electrocardiogram (ecg) and laboratory evaluation (hematology, biochemistry, urinalysis) as assessed by the investigator. * no current or recurrent disease (e.g. cardiovascular, renal, liver, gastrointestinal (gi), malignancy or other conditions) that could affect the action, absorption or disposition of the investigational products utilized in this study, or could affect clinical or laboratory assessments. exclusion criteria * current or recurrent disease (eg, cardiovascular, renal, liver, gi, malignancy or other conditions) that could affect the action, absorption or disposition of the investigational products utilized in this study, or could affect clinical or laboratory assessments. * current or relevant previous of physical or psychiatric illness, any medical disorder that could have required treatment or made the subject unlikely to fully complete the study, or any condition that presented undue risk from the investigational product or study procedures. * current use of any medication with the exception of hormonal replacement therapy or hormonal contraceptives within 14 days of first dose of investigational product. * history of alcohol or other substance abuse within the last year. * a positive human immunodeficiency virus antibody screen, hepatitis b surface antigen or hepatitis c virus antibody screen. * use of tobacco in any form * donation of blood or blood products (eg, plasma or platelets) within 60 days prior to receiving the first dose of investigational product.
treating suicidality remotely

Conditions: Suicide Attempt

Summary: background: practical and psychological barriers make it difficult for people with suicidal thoughts and behaviors (stbs) to get professional help. online interventions have the potential to overcome many of these barriers, but the online interventions to date have produced small or short-lived effects and have only been found to reduce suicidal thoughts, not behaviors. this is a crucial limitation, since previous studies have shown that interventions that reduce suicidal thoughts often do not prevent suicide attempts, and vice versa. methods: a fully remote randomized controlled trial will be conducted in which 364 participants of 16 years and older will be recruited through the website of a suicide prevention helpline in the netherlands and randomized with an allocation ratio of 1:1 to either brief cognitive behavioral therapy for suicide prevention (bcbt-sp) or a semi-guided online self-help course that has previously been found superior to waitlist in reducing suicidal thoughts. the primary outcome of the study is the number of suicide attempts, measured with the columbia suicide severity rating scale. secondary outcomes are self-reported suicidal ideation, healthcare utilization, treatment satisfaction, adverse effects, and quality of life. all outcomes will be assessed at baseline, immediately after the treatment and at 18 months follow-up. discussion: if remote bcbt-sp proves effective, the findings of this study will add to the evidence base of bcbt-sp as one of very few psychological interventions with replicated effectiveness in preventing suicide attempts and provide the first evidence to date that remote interventions cannot only reduce suicidal thoughts, but also prevent suicidal behavior.


Eligibility criteria:
inclusion criteria: * 16 years or older * currently living in the netherlands * any type of stbs in the past 4 weeks exclusion criteria: * insufficient mastery of the dutch language * previously engaged in 113 suicide prevention's online therapy or self-help course * currently seeing a mental health professional at least once every 3 weeks, other then a general practitioner or general practice based nurse practitioner ('poh-ggz') * not able to engage in online therapy, for instance because of severe mood disorders or psychotic symptoms, based on the clinical impression of the research assistant and a supervisor

Keywords: suicide attempts ideation telehealth e-health remote cbt self-help
effects of tibilone on bone density, menopause symptoms and breast density in women after prophylactic oophorectomy

Conditions: Menopause; Postmenopausal Bone Loss; Breast Cancer

Summary: women undergoing surgical menopause often experience marked menopausal side effects but are reluctant to use estrogen or other female hormones to ease the transition to menopause because of worries that the hormones may increase breast cancer risks. this study will evaluate tibolone in women experiencing surgical menopause to assess its effects on bone health, menopause symptoms and breast density.

women interested in participating in this study will be allowed to use hormones to manage symptoms for up to 3 months before beginning the study. those choosing not to take hormones may enroll in the study immediately. all women will have a baseline mammogram, breast examination, and bone study density performed, along with blood and urine analysis for measurement of bone markers. they will also be asked to take a questionnaire. patients will take either tibolone or placebo once daily for 1 year. neither the patient or the physician will be aware of which treatment a woman is taking during the study. patients will return at 6 and 12 months to have a physical examination, blood work, urine collection and bone studies. at one year, a repeat mammogram will be performed. there are also some questionnaires asking about menopause symptoms that will be performed at intervals during the study. it is also recommended that patients take calcium and vitamin d throughout the study.

Eligibility criteria:
inclusion criteria: * good overall health * premenopausal at the time of enrollment if before their oophorectomy * will undergo or have undergone an oophorectomy * negative breast examination and negative breast imaging studies exclusion criteria: * history of breast cancer, ductal carcinoma in situ (dcis) or other cancer except for carcinoma in situ of the cervix or basal cell carcinoma of the skin * history of ovarian cancer, breast cancer (or dcis) or other malignancy * low bone mass compared with age-adjusted controls * current or recent exposure (within 3 months) to medications that alter bone metabolism * estrogens, progesterones, androgens, tamoxifen or raloxifene within 3 months of randomization * history of significant medical problems potentially related to estrogens * history of paget's disease of bone, ankylosing spondylitis, rheumatoid arthritis or other metabolic bone disease, vitamin d deficiency, hyperparathyroidism, or newly diagnosed hyperthyroidism * body mass index (bmi) \> 32 * high-density lipoprotein (hdl) cholesterol \< 40 mg/dl * women whose uterus was retained and who have a history of uterine abnormalities

Keywords: tibolone high risk women oophorectomy breast density bone density
study comparing bifeprunox to risperidone in treatment of outpatients with schizophrenia with weight as primary endpoint

Conditions: Schizophrenia

Summary: the purpose of this study is to determine the effect of bifeprunox or risperidone on the body weight of patients with schizophrenia.


Eligibility criteria:
inclusion criteria: * current treatment of at least 3 months with risperidone. * primary diagnosis of schizophrenia. * total positive and negative symptoms scale (panss) score \< or = 70 at screening and baseline. exclusion criteria: * psychiatric diagnosis other than schizophrenia as assessed by the modified mini international neuropsychiatric interview (mini) and considered by the investigator to be the primary psychiatric diagnosis. * history or presence of clinically significant cardiovascular, endocrine, hepatic, renal or other medical disease that might be detrimental to the subject or confound the study. * history of any suicide attempt within 3 years of day 1 or significant immediate risk of violence or suicidality.

Keywords: schizophrenia
single incision laparoscopic surgery (sils) versus laparoscopic cholecystectomy

Conditions: Cholelithiasis; Biliary Dyskinesia

Summary: prospective randomized trial of single incision versus standard 4 port laparoscopic cholecystectomy. hypothesis is that the operative time will be longer with single incision.

this will be a prospective, randomized clinical trial involving patients who present to the hospital with an indication for cholecystectomy. we will offer enrollment to several institutions provided they receive institutional approval. this will be a definitive trial design. based on our operative times with sils compared with our recent experience in standard laparoscopy, a sample size of 60 patients will give us a power of 0.8 with an α of 0.05. after the procedure, both groups will be managed in the same manner per routine care. they will be discharged when tolerating a regular diet and their pain is well-controlled on oral pain medication.

Eligibility criteria:
inclusion criteria: * need for cholecystectomy exclusion criteria: * need for cholangiogram

Keywords: sils laparoscopic cholecystectomy children
hypoglycemia and glucagon response in cf

Conditions: Cystic Fibrosis; Hypoglycemia; Glucagon Deficiency; Pancreatic Insufficiency

Summary: the goal of this clinical trial is to investigate the etiopathogenesis of isolated hypoglycemia and hypoglycemia with abnormal glucose tolerance in children with cystic fibrosis (cf) and to evaluate the role of glucagon and pancreatic insufficiency on hypoglycemia in cf. the main questions it aims to answer are: 1. do isolated hypoglycemia and hypoglycemia with abnormal glucose tolerance have different etiopathogenesis? 2. what is the role of pancreatic insufficiency in these two conditions? participants were asked to perform 3-h ogtt and to take blood samples. researchers compared with healthy peers to see if there is isolated hypoglycemia in ogtt and how is the glucagon response to ogtt in healthy peers.

the exact underlying mechanism of hypoglycemia in cf is still unknown. some recent studies support the delayed and prolonged insulin secretion and impaired counterregulatory hormone response as the reason of reactive hypoglycemia, whereas the others argued an additive effect of an intrinsic factor. however, the weakness of these limited studies is that nearly all of them included cf patients who had pancreatic insufficiency (pi) and could not reveal the mechanism of hypoglycemia seen in those without pi. in addition, there were no healthy controls for comparison of glucagon secretion in cf patients with hypoglycemia. moreover, the studies that evaluate the role of glucagon in hypoglycemic cf patients were performed in hypoglycemic adult patients with abnormal glucose tolerance (agt) and the delayed and prolonged insulin release is expected to be more likely as the reason of hypoglycemia in this setting. previously, the investigators had demonstrated isolated hypoglycemia in some of the pediatric cf patients during ogtt. in this study, the investigators aimed to further investigate possible mechanisms of hypoglycemia. the investigators hypothesized that the mechanism of isolated hypoglycemia might be different from hypoglycemia seen in patients with agt. furthermore, the investigators evaluated the role of pancreatic insufficiency in hypoglycemia of cf patients by analyzing glucose, insulin and glucagon response to a glucose load in cf patients with and without pi.

Eligibility criteria:
inclusion criteria: * 10-18 year-old children genetically diagnosed with cystic fibrosis * regularly followed by the department of pediatric endocrinology exclusion criteria: * using corticosteroid therapy in the last 3 months * those who had acute exacerbation in the last 3 months * previously diagnosed with diabetes
olfactory cleft obstruction and electrophysiological field potentials predict olfactory restoration by dupilumab in crswnp patients.

Conditions: Chronic Rhinosinusitis Phenotype With Nasal Polyps (CRSwNP); Smell Loss

Summary: the goal of this observational study is to learn what can predict the return of the sense of smell in patients with chronic rhinosinusitis with nasal polyps being treated with dupilumab. the main questions it aims to answer are: 1. does obstruction of the olfactory cleft predict return of the sense of smell? 2. do electrophysiological signals generated by breathing and sniffing behavior predict return of the sense of smell? participants starting dupilumab will undergo assessment for their degree of olfactory cleft obstruction, and an electrophysiologic assessment of their olfactory cleft and be followed over 6 months of treatment with dupilumab.


Eligibility criteria:
* well documented history of crswnp * bsit age/sex classified as "abnormal" score * self-reported stable olfactory deficit of moderate to severe quality \> 3 months * prior endoscopic sinus surgery \>3 months, \<10 years prior

Keywords: dupilumab chronic rhinosinusitis with nasal polyps smell loss electrophysiology
impact of childrens preparation before mri on anxiety and need for anesthesia: a prospective randomized clinical trial

Conditions: Proportion of Anesthesia; Anxiety Level

Summary: mri has been recognized for many years as the safest and the most precise imaging method, particularly for children. however, the accuracy of mri demands from the patient to avoid any movement while the examination is in process. this task is accomplished with difficulty by children and requires the assistance of an anesthetizing staff. in this research, our main goal is to investigate an introductory instruction as an assistive tool in performing mri without the need in anesthesia.

this is a prospective randomized controlled trial in which the level of the child's exposure to instruction is controlled according to the group he is attributed to. the children are divided randomly, each sunday (the day there is an available anesthesia staff) we change the extent of the instruction. we use two types of instructions: 1) full interactive instruction- which will include an instructional booklet, a movie and a simulator's practice. 2) partial instruction which will include the booklet only. therefore, if it is a full instruction sunday, all the children in that day receive full instruction and vice versa, if it will is a partial instruction sunday, all the children in that day receive partial instruction. all participants provide written informed consent after the study aims and procedures are fully explained.

Eligibility criteria:
inclusion criteria: * all children in the age between 5 to 16 years who come ambulatory or were hospitalized to perform an mri test, speaks hebrew or arabic, are capable of understanding to their age, and their parents agreed to take part in the research exclusion criteria: * severe cerebral palsy * severe adhd * children that lack of communication skills
the effect of thoracic mobilization in individuals with subacromial pain syndrome

Conditions: Subacromial Pain Syndrome

Summary: the purpose of this study is to investigate the effect of six-week thoracic mobilization on pain intensity, muscle tone, functional and muscle activation in individuals with subacromial pain syndrome.

subacromial pain syndrome (saps) is the most common shoulder problem and accounts for 44%-65% of all shoulder problems. repetitive compression of the rotator cuff tendons as they pass through the subacromial space affects shoulder function along with pain. studies have shown that scapular kinematics are affected in individuals with subacromial pain syndrome. in addition to increased scapular internal rotation, scapular upward rotation and posterior tilt during elevation are decreased in these individuals. these kinematic changes have been associated with decreased activation of the middle and lower trapezius and serratus anterior muscles and excessive upper trapezius activation. this change in scapular kinematics causes narrowing of the subacromial space and repeated traumatization of the rotator cuff muscles passing through it. in addition, kyphotic posture in the thoracic region (insufficient extension of the thoracic vertebrae) negatively affects scapular kinematics. kyphotic posture has been shown to be associated with subacromial pain syndrome by causing anterior tilt, downward rotation and protraction in the scapula. exercise and mobilization applications are frequently applied in subacromial pain syndrome. strengthening the muscles around the shoulder and scapula, increasing glenohumeral and scapulothoracic joint mobility, and stretching the posterior capsule are frequently applied to reduce pain and increase function. studies on increasing thoracic mobilization are limited in number. in these studies, the acute effects of thoracic manipulation applications on pain, normal joint motion and functional activity level were examined in individuals with subacromial pain syndrome. there is only one pilot study that examined the effect of mobilization applied to the thoracic region. the purpose of this study is to investigate the effect of six-week thoracic mobilization on pain intensity, muscle tone, functional and muscle activation in individuals with subacromial pain syndrome.

Eligibility criteria:
inclusion criteria: * thoracic kyphosis angle \> 40° * full active shoulder abduction exclusion criteria: * bilateral shoulder pain * rotator cuff tear * shoulder/cervical injury other than saps * surgery history

Keywords: rehabilitation electromyography acromiohumeral distance pain
survivorship and outcomes of robotic-arm assisted bicompartmental arthroplasty

Conditions: Osteoarthritis

Summary: the purpose of the study is to determine the clinical outcomes and survivorship of robotic-arm assisted medial bicompartmental knee arthroplasty at two, five, seven and ten years postoperative.

the purpose of the study is to determine the survivorship, patient satisfaction and clinical outcomes of robotic-arm assisted medial bicompartmental knee arthroplasty using the mck implant system starting at two years post-operative and continuing for five, seven and ten years post-operative.

Eligibility criteria:
inclusion criteria: * all patients over 21 years of age who underwent robotic-arm assisted medial bicompartmental arthroplasty by the investigating surgeon and received mck implants and are at least 24 months post-operative. * patient has signed an irb approved informed consent form or with irb approved waiver of written signed consent, patient has verbally consented to study participation. * patient is willing to comply with follow up exclusion criteria: * patients will be excluded from participation in the study if they are cognitively unable to answer questions related to their index procedure and health quality of life forms. * patient had active infection * implants were implanted without bone cement * patients did not have sufficient bone stock to allow for insertion and fixation of components * patient did not have sufficient soft tissue integrity to allow for stability * patient had a neurological or muscular deformity that did not allow for control of the knee.

Keywords: osteoarthritis medial bicompartmental patellofemoral