Kornimate/medical-research-clean huggingface dataset:
a research study to look at similarity between semaglutide versions in different injection tools

Conditions: Diabetes Mellitus, Type 2

Summary: this study will compare four different semaglutide versions and different injection tools. the study aims to show similar levels of semaglutide in the blood using different versions of semaglutide. the researchers also want to look at how well the injection tools work. participants will get two versions of semaglutide at two separate dosing visits. one of them is a version that doctors already can prescribe and the other will be one of the new versions. which version participants get first is decided by chance. participants will get semaglutide as an injection under the skin. the time between injections is 7 to 8 weeks. the study will last for about 16 weeks. participants will have 27 study visits with the study doctor. for two of the visits, participants will stay at the clinic for 4 days and 3 nights.


Eligibility criteria:
inclusion criteria: * male or female, aged 18-55 years (both inclusive) at the time of signing informed consent. * body mass index between 20.0 and 29.9 kg/m\^2 (both inclusive). * considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator. exclusion criteria: * any disorder which in the investigator's opinion might jeopardise subject's safety, evaluation of results, or compliance with the protocol. * use of prescription medicinal products or non-prescription drugs or herbal products, except routine vitamins, topical medication, highly effective contraceptives and occasional use of paracetamol, within 14 days prior to the day of screening. * abuse or intake of alcohol, defined as any of the below: a) known or suspected alcohol abuse within 1 year prior to the day of screening (defined as regular intake of more than 24 g alcohol daily for men and 12 g alcohol daily for women. b) positive alcohol test at screening. * abuse or intake of drugs, defined as any of the below: a) known or suspected drug/chemical substance abuse within 1 year prior to the day of screening. b) positive drug of abuse test at screening. * female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using highly affective contraceptive methods.
combining myocardial strain and cardiac ct to optimize left ventricular lead placement in crt treatment

Conditions: Heart Failure

Summary: for patients with advanced heart failure, cardiac resynchronization therapy (crt) has been a major improvement. the treatment improves symptoms and prolongs life in selected patients with heart failure. however, with the current selection criteria and methods for implanting the pacemaker, only 60-70% of the patients derive significant benefit from the treatment. new imaging techniques, including advanced ultrasound and computed tomography, in combination with new versatile multi-pole electrodes, have made an individually tailored therapy possible. using these techniques in combination, the study will investigate the effect of individually based "optimal" placement of the pacemaker electrodes vs. standard care. the optimal lv electrode position is defined as pacing a viable segment with the latest mechanical delay, targeting a specific segment of the coronary sinus as visualised on cardiac ct. the hypothesis is that this will increase the number of positive responders from 65% to 85%.


Eligibility criteria:
inclusion criteria: * symptomatic heart failure (new york heart association functional class ii - iv) despite stabile optimal medical therapy. * wide qrs ≥ 120 milliseconds on standard ecg. * lv systolic dysfunction (ef ≤ 35%). * written informed consent. * accepted for crt-p or crt-d treatment exclusion criteria: * life expectancy \< 12 months. * recent myocardial infarction (\< 3 months). * significant valve disease * chronic atrial fibrillation * pregnancy * severely impaired renal function (estimated glomerular filtration rate (egfr) \< 30 ml/min) * unable to give written informed consent.

Keywords: cardiac resynchronization therapy echocardiography cardiac computed tomography
evaluation of the use of indomethacin as co-treatment in women with preterm labor and high risk of intraamniotic inflammation

Conditions: Preterm Labor With Intact Membranes

Summary: to demonstrate if indomethacin associated to conventional treatment for preterm labor is useful to delay delivery and to improve neonatal morbimortality in women with preterm labor with high risk of intraamniotic inflammation

randomised patients would be assigned to receive indomethacin either placebo oral use(50 mg every 6 hours during 5 days) to evaluate the efficacy of indomethacin as complementary treatment to increase the gestational age at delivery in women admitted with preterm labor and intact membranes with high risk of intraamniotic inflammation, defined as a gestational age at admission less than 28.0 weeks or those women from 28-32.0 weeks with a sonographic cervical length less than 15 mm

Eligibility criteria:
inclusion criteria: * pregnant women with preterm labor admitted to hospital and treated with tocolysis * pregnant women less than 28.0 and those women from 28.0 to 32.0 with a sonographic cervical length \< 15 mm * single pregnancy * normal amniotic fluid * normal arterial ductus exclusion criteria: * age below 18 years * previous use of indomethacin in the index pregnancy * chorioamnionitis, preterm prelabour rupture of membranes or those fetal or maternal pathologies which could be responsible of an iatrogenic preterm delivery. * oligohydramnios * allergy to nsaid * previous history of gastrointestinal bleeding * use of nsaid contraindicated * not adherence to the study

Keywords: preterm labor
an observational study evaluating anti-idursulfase serum antibody response in hunter syndrome patients

Conditions: Hunter Syndrome

Summary: the objective of this study is to evaluate the effect of anti-idursulfase antibodies on idursulfase safety (measured by infusion related adverse events) between patients who develop anti-idursulfase antibodies and patients who do not after long-term idursulfase enzyme replacement therapy (ert).

this study is being conducted to satisfy post-marketing commitments to monitor anti-idursulfase antibody development in hunter syndrome patients after long-term idursulfase enzyme replacement therapy. the study will be conducted as a sub-study within the hunter outcome survey (hos). hunter syndrome patients in the hos who have previously received idursulfase as well as treatment-naive patients who will begin idursulfase treatment within 30 days of study enrollment will be included.

Eligibility criteria:
inclusion criteria: patients must meet all of the following criteria to be considered eligible for enrollment: * the patient is male and enrolled in the hos (i.e., meets the entry criteria of a documented diagnosis of hunter syndrome) * the patient is ≥ 5 years-old * the patient is on idursulfase treatment or scheduled to begin idursulfase treatment within 30 days of study enrollment * the patient, patient's parent(s), or patient's legally authorized guardian must have voluntarily signed an institutional review board (irb)/independent ethics committee (iec)-approved informed consent form after all relevant aspects of the study have been explained and discussed with the patient, patient's parent(s), or patient's legally authorized guardian. exclusion criteria: patients who meet any of the following criteria are not eligible for this study: * the patient has received biologic/ert products other than idursulfase, or other investigational product(s) for any reason within 30 days prior to study entry. * the patient has a life expectancy of \< 2 years * the patient is unable to comply with the protocol, e.g., has a clinically relevant medical condition making implementation of the protocol difficult; has an uncooperative attitude; is unable to return for safety evaluations; or is otherwise unlikely to complete the study, as determined by the investigator.

Keywords: mps 2 mpsii hunter's disease treatment enzyme replacement therapy hunter's disease iduronate 2 sulfatase mps diagnosis mps symptoms iduronate sulfatase mps ii treatment chronic ear infection hunters syndrome mps ii therapy mps2 hunter's syndrome hunter syndrome elaprase lysosomal storage disease hunter syndrome therapy mps society hunter syndrome treatment hunter's syndrome treatment mucopolysaccharides mps ii idursulfase hunters disease enlarged adenoids ert treatment hunter disease lysosomal storage disorder
impact of perioperative nutrition intervention on bioimpedance phase angle (ipenipa) in breast cancer patients

Conditions: Breast Cancer Early Stage Breast Cancer (Stage 1-3); Mastectomy Patient

Summary: the goal of this clinical trial is to measure the mean difference of phase angle after nutritional intervention in breast cancer patients. the main question it aims to answer is: 1. can perioperative nutrition interventions improve phase angle in relation to other bioimpedance parameters, handgrip strength and surgical outcomes in breast cancer population? researchers will compare oral nutritional supplement to a placebo to see if oral nutritional supplement can improve phase angle. participants will: 1. be randomized into either arm 2. take oral nutritional supplement or placebo according to the result of randomization for 7 days preoperatively and 30 days postoperatively 3. have their measurements (weight, height, phase angle, handgrip strength) done at least 7 days preoperative, 1 day preoperative and 30 days postoperative


Eligibility criteria:
inclusion criteria: * female * histopathologically confirmed operable breast cancer * aged 18 of years and above * consented and scheduled for mastectomy exclusion criteria: * on enteral supplementation prior to the study * lactose intolerance * pregnant or lactating * previous history of gastrectomy or small bowel resection surgery * advanced breast cancer staging, presence of pacemaker, decompensated liver disease, end stage renal failure, uncontrolled diabetes, on steroid therapy or complementary traditional medications

Keywords: bioimpedance phase angle nutritional intervention oral nutritional supplement
pain, exercise and psychological well-being in pectus excavatum

Conditions: Pectus Excavatum

Summary: recovery following major surgical procedures can be influenced by both physical (optimization of cardiopulmonary function, pain control, activity) and psychological factors. physical activity recommendations for post-operative patients is difficult, in part because little is known about the short- and long-term benefits of exercise and mobility on post-operative pain and return to normal functioning.

major surgery has a drastic impact on the lives of patients and their families. often, patients undergoing the nuss procedure have lingering pain which can complicate recovery. depending on the nature of the surgery and the severity of disease, this recovery period can be as short as a few days, or it can take several weeks and even months. few studies have demonstrated the benefit of physical activity and exercise postoperatively on returning to normal function. additionally, research has suggested that pain and recovery can be influenced by psychological factors. the investigators will use wireless activity monitors to assess the activity levels of children who undergo major musculoskeletal surgery, specifically the nuss procedure. the investigators will also evaluate this population for psychological well-being. in this pilot study, the investigators identify goals and objectives which will provide preliminary evidence for physical and psychological recommendations to reduce post-operative pain and improve recovery. families will be asked to complete questionnaires at different phases in the surgery (pre-surgery, post bar insertion, post bar removal). children will be instructed to record any pain they are experiencing as a result of their condition or the surgery at various time points. the activity levels will also be followed over the course of the recovery period.

Eligibility criteria:
inclusion criteria: * children between the ages of 12-18 years that are scheduled to undergo a surgical procedure for the correction of pectus excavatum exclusion criteria: * history of chronic pain disorders * history of major mental illness such as psychosis or bipolar disorder * cognitive impairment significantly below average age and/or grade level * non-english speaking parent or child * unable to obtain and keep access to a cellular phone * loss of wireless electronic activity monitor and refusal to replace to remain in the study

Keywords: sunken chest caved-in chest chest deformity sunken sternum
c-reactive protein (crp) gene variants and coronary artery disease in a chinese han population

Conditions: Coronary Artery Disease

Summary: the recognition of the association between circulating c-reactive protein (crp) levels and risk of coronary heart disease (chd) has led to an increased emphasis on crp genetic effects on crp level and chd. however, the causality of crp variants remains uncertain.the objective of this study is to evaluate the association of crp gene variants and crp levels in chd in chinese han population. we conduct case-control study in crp-han study participants. the common single-nucleotide polymorphisms (snps) in the crp gene, haplotypes, and plasma crp levels are detected. a mendelian randomization analysis will be used to help test the likelihood of causal association of gene-crp levels, crp levels-chd and gene-chd. the investigators hypothesize that crp gene variants influence the protein level and may participate in chd progress.

chd patients and non-chd population are recruited. crp level and chd severity by coronary angiograph will be examined. mendelian randomization analysis are taken to analyze statically.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of coronary artery disease exclusion criteria: * with major organ disfunction or acute inflammatory disease

Keywords: crp coronary artery disease polymorphisms
mommio: training in vegetable parenting

Conditions: Obesity

Summary: a 20 episode video game called mommio simulates parent-child feeding interactions for parents of 3-5 year old children within a storyline addressing a problem commonly reported by parents (getting their 3-5 yo to taste a vegetable, which is often a first step toward eating the vegetable), thereby training parents in effective food parenting practices. this research evaluates whether the 20 episodes targeting barriers identified by parents across five levels of difficulty influences vegetable parenting practices and children's dietary intake. we had to discontinue the study since changes in commercial availability of game development software required reprogramming and available funding did not allow for completion of game programming. thus, no game evaluation was possible.

video games for parents that simulate interactions with a child using a narrative, offering feedback on performance and goal setting for changing practices in the real world, and addressing vegetable (v) feeding problems commonly reported by parents, may elicit desirable cognitive, affective, and behavioral outcomes. the rationale for training parents of preschool children in effective v parenting practices is that: 1) parents have an important influence on young children's dietary intake; 2) child dietary intake tracks into the adult years; and 3) high v consumption protects against several chronic diseases later in life. since parents of young children commonly complain about not getting their child to eat v, there should be broad interest in playing mommio. a pre-post randomized clinical trial with 110 parents of 3-5 year olds who report having difficulty getting their child to eat vegetables will be employed. the primary outcome will be parent report of children's dietary intake; the secondary outcome will be use of v parenting practices. we had to discontinue the study since changes in commercial availability of game development software required reprogramming and available funding did not allow for completion of game programming. thus, no game evaluation was possible.

Eligibility criteria:
inclusion criteria: * being a parent of a child 3-5 years old * willing to complete all measures * having an iphone. exclusion criteria: * the parent not speaking english (since the games are in english alone, due to budget constraints); * having a 3-5 year old child with a medical condition that influences diet; or * a parent with an illness that impairs the ability to complete questionnaires

Keywords: vegetables dietary intake preschoolers parents video game
feasibility and outcomes of older patients hospitalization

Conditions: Community-Acquired Pneumonia; Exacerbation of Chronic Heart Failure; Exacerbation of Chronic Obstructive Pulmonary Disease; Cellulitis

Summary: hospitalization is a traumatic event for the patient and his family at any age nevertheless in the older age. one of its consequences is the difficulty to resume previous activity of daily living especially in older (over 75 years) patients. sub acute completes the acute phase of the hospitalization and its main purpose is to improve the patient's functional status and quality of life. there are not enough clinical trails to proof this assumption. the purpose of our study is to compare the outcome of acute and sub-acute hospitalization programs by a randomized controlled prospective intervention study. outcome measures will comprise activity of daily living, functional status, re-hospitalization and utilization of medical services following the hospitalization.study hypothesis is that sub-acute hospitalization will improve outcomes and will cost less.


Eligibility criteria:
inclusion criteria: * age over 65 * hemodynamic, nutritional and respiratory stability * eligibility for sub- acute hospitalization exclusion criteria: * oncological active disease * uncorrectable hypoxemia (oxygen saturation 90%), * suspected myocardial ischemia * presence of an acute illness, other than the target illness

Keywords: subacute care activities of daily living cognition assessment mood assessment incontinence control
safety and efficacy of sentinel node biopsy omission for breast cancer patients who plan to have adjuvant chemotherapy

Conditions: Breast Cancer

Summary: eligible patients will be female, ages 18 and older and have a diagnosis of clinical t1 or t2 invasive breast cancer with no suspicious palpable adenopathy. patients will undergo standard of care lumpectomy without sentinel node biopsy and whole breast radiation, followed by chemotherapy. sentinel node biopsy is also considered standard care when patients have localized breast cancer. treatment can often be influenced by whether the results of the biopsy show cancer or not. however, the biologic factors of the primary tumor have become more important in determining treatment recommendations in women with clinically node negative breast cancer.

the primary objective of the study is to determine the locoregional recurrence rate in patients with clinically node negative t1 and t2 breast cancer treated with systemic chemotherapy and whole breast irradiation in whom biopsy of the sentinel node is not performed. a locoregional recurrence is defined as any recurrence in the ipsilateral axillary nodes or in the supraclavicular nodes. after surgery, a patient will receive standard of care radiation on her affected breast and chemotherapy. a physical examination of the affected breast and regional lymph nodes will be conducted every six months for the first two years of follow up and then yearly for the last 3 years of follow up. imaging of the affected breast will occur every 12 months after surgery per standard of care.

Eligibility criteria:
inclusion criteria: * female age 18 and older, not pregnant or lactating * clinical t1 or t2 invasive cancer with no suspicious palpable adenopathy * if abnormal axillary nodes are seen on preoperative imaging, a negative fine needle aspiration or core biopsy is required for study entry. * planned treatment with breast conserving surgery and whole breast irradiation * chemotherapy required postoperatively based on patient and tumor characteristics at diagnosis exclusion criteria: * patients with suspicious palpable axillary adenopathy * patients with biopsy demonstrating axillary nodal metastases * patients with treatment by mastectomy * patients who have undergone neoadjuvant chemotherapy * patients with co-morbidities rendering the patient not a candidate for chemotherapy, surgery, or irradiation * patients treated with accelerated partial breast irradiation (apbi) * patients with contraindication to radiation

Keywords: clinically node negative t1 and t2 invasive breast cancer
cerebral oxymetry and neurological outcome in therapeutic hypothermia

Conditions: Hypoxic-Ischemic Encephalopathy; Post-Cardiorespiratory Arrest Coma; Cardiac Arrest

Summary: this study is designed to assess the effect of cerebral oxygen saturation as an early predictor of neurological outcomes in patients undergoing therapeutic hypothermia after cardiac arrest

our study is planned as a prospective observational study. patients undergoing therapeutic hypothermia in our intensive care unit after cardiac arrest will be enrolled. each patient's cerebral oxygenation will be monitored with near-infrared spectroscopy (nirs) in every 6 hours during our 24 hour lasting hypothermia period. afterwards, patients will be monitorised in every 6 hours during the first day of hypothermia and than the mean values of daily cerebral oxygen values will be noted in the third, fourth and fifth days of nomothermia. regional oxygen saturation (rso2) will be noted from left and right probes. full outline of unresponsiveness (four) score, glasgow coma score (gcs) and cerebral performance category scale (cpc) will be noted at the beginning of therapeutic hypothermia and each day during normothermia, day 21 and the day of discharge from icu.

Eligibility criteria:
inclusion criteria: * patients at least 18 years old * patients undergoing therapeutic hypothermia exclusion criteria: * patients under 18 years * patients unsuitable for therapeutic hypothermia

Keywords: therapeutic hypothermia targeted temperature management neurological outcome post-cardiac arrest syndrome
efficacy and safety of ranibizumab in patients with subfoveal choroidal neovascularization (cnv) secondary to age-related macular degeneration (amd)

Conditions: Age Related Macular Degeneration

Summary: the study will test if the efficacy and safety of an alternative dosing regimen is as effective as monthly injections.


Eligibility criteria:
inclusion criteria: * patients with primary or recurrent subfoveal cnv secondary to amd, including those with predominantly classic, minimally classic or occult lesions with no classic component * patients who have a bcva score between 73 and 24 letters, inclusively, in the study eye using etdrs-like grading charts (approximately 20/40 to 20/320) exclusion criteria: * prior treatment in the study eye with verteporfin, external-beam radiation therapy, subfoveal focal laser photocoagulation, vitrectomy, or transpupillary thermotherapy. * history of submacular surgery or other surgical intervention for amd in the study eye, glaucoma filtration surgery, corneal transplant surgery. * laser photocoagulation (juxtafoveal or extrafoveal) in the study eye within one month preceding baseline. other protocol-defined inclusion/exclusion criteria applied to the study.

Keywords: age-related macular degeneration, ranibizumab