Kornimate/medical-research-clean huggingface dataset:
efficacy and long-term safety of oral semaglutide versus sitagliptin in subjects with type 2 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this trial is conducted globally. the aim of the trial is to investigate efficacy and long-term safety of oral semaglutide versus sitagliptin in subjects with type 2 diabetes.


Eligibility criteria:
inclusion criteria: * male or female, age at least 18 years at the time of signing informed consent for japan only: male or female, age at least 20 years at the time of signing informed consent * diagnosed with t2dm (type 2 diabetes mellitus) for at least 90 days prior to day of screening * hba1c (glycosylated haemoglobin) 7.0-10.5 % (53-91 mmol/mol) (both inclusive). * stable daily dose of metformin (equal or above 1500 mg or maximum tolerated dose as documented in subject medical record) alone or in combination with su (= half of the maximum approved dose according to local label or maximum tolerated dose as documented in subject medical record) within 90 days prior to the day of screening exclusion criteria: * female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using adequate contraceptive methods (adequate contraceptive measures as required by local regulation or practice). for certain specific countries: additional specific requirements apply * family or personal history of multiple endocrine neoplasia type 2 (men 2) or medullary thyroid carcinoma (mtc) * history of pancreatitis (acute or chronic) * history of major surgical procedures involving the stomach potentially affecting absorption of trial product (e.g. subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery) * any of the following: myocardial infarction, stroke or hospitalization for unstable angina and/or transient ischaemic attack within the past 180 days prior to the day of screening * subjects presently classified as being in new york heart association (nyha) class iv. * planned coronary, carotid or peripheral artery revascularisation known on the day of screening. * renal impairment defined as estimated glomerular filtration rate (egfr) below 60 ml/min/1.73 m\^2 as per chronic kidney disease epidemiology collaboration (ckd-epi) * history or presence of malignant neoplasms within the last 5 years (except basal and squamous cell skin cancer and in-situ carcinomas)
use of thalidomide in chronic uveitis

Conditions: Uveitis

Summary: this research study is for patients that have been diagnosed with chronic uveitis, a disease that causes inflammation in the eye. patients are currently being treated with remicade, humira, methotrexate and or similar chemotherapy type drugs to control this inflammation. despite these medications, patients still have inflammation in their eyes. patients are being asked to add an additional drug, thalidomide.

patients will be in the study for approximately 24 weeks. the visits are at screening, baseline (week 0), and weeks 4,8,12, and 24. the purpose of this research study is to see if thalidomide is safe and effective in the treatment of patients with chronic inflammation in their eyes. thalidomide is approved by the food and drug administration (fda) for a leprosy skin condition, erythema nodosum leprosum (enl). the drug works in many different ways, including as an anti-inflammation drug. therefore, it is thought that this drug might be able to improve symptoms and lung function. at this time, the drug is not approved for use for uveitis.

Eligibility criteria:
inclusion criteria: * you are being asked to take part in this research study because you have been diagnosed with chronic uveitis, a disease that causes inflammation in the eye. you are currently being treated with remicade, humira, methotrexate and or similar chemotherapy type drugs to control this inflammation. despite these medications, you still have inflammation in your eyes. you are being asked to add an additional drug, thalidomide. exclusion criteria: * you will not participate in this research study if any of the following apply to you: * pregnant * if you are a man or woman not willing to take adequate birth control measures comply with fda-mandated s.t.e.p.s.â program. . * if you are a breast feeding woman * if you have a significant peripheral neuropathy (numbness or tingling in your hands or feet) * have had a recent blood clot in your leg or lungs * if you are currently receiving biphosphonates such as zoledronic acid (fosamax)

Keywords: sarcoidosis chronic uveitis uveitis thalidomide
evaluation of the analgesia nociception index and videopupillometry to predict a child's post-tonsillectomy morphine prescription

Conditions: Pain, Postoperative

Summary: some surgeries, such as tonsillectomies, are particularly painful postoperatively because they are not very accessible to a complementary technique of loco-regional anesthesia and require the use of opioids in the postoperative period. the use of opioids, in combination with usual analgesics, is common after this surgery. however, some risks are associated with the use of morphine in children, including more frequent respiratory distress, nausea and vomiting, and can cause hemorrhagic complications and lengthen the duration of hospitalization. decreasing the consumption of morphine drugs is therefore a real challenge. although there is no randomized controlled study on the use of standard analgesics with or without morphine to date, a number of studies suggest that the use of morphine should not be systematic after a surgery. the need for opioids after tonsillectomy as well as the level of pain vary between patients. some teams use morphine at the end of general anesthesia to prevent pain on waking and others use it only if needed, once the child is awake. pain assessment scales are used in the post-interventional monitoring room (pimr) to adapt these analgesic therapies according to the intensity of pain. one of the validated and frequently used scales in pediatric pimr is flacc (face legs activity cry consolability). monitoring tools are also available to evaluate the quality of intraoperative analgesia in unconscious children : * the analysis of the pupillary variation in response to a painful stimulus by videopupillometry, * and the ani (analgesia nociception index) which consists of estimating the sympathetic-parasympathetic balance by a complex analysis of cardiac rhythm variability. these two types of monitoring could predict which children will require post-operative morphine treatment. to date, no study has demonstrated the relationship between videopupillometry and postoperative morphine consumption. the average ani has already been evaluated in children as correlated with flacc but both monitoring devices have never been compared for a predictive purpose. the investigators hypothesize that the use of the ppi® (pain pupillary index) scale of algiscan® and the average ani measured by the physiodoloris® monitor in children still sedated at the end of the intervention could have a prognostic value on post-operative morphine prescription.


Eligibility criteria:
inclusion criteria: * any child for whom tonsillectomy is programmed ≥ 2 years and up to 7 years inclusive * consent written and signed by at least one holder of exercise of parental authority exclusion criteria: * eye disease * cardiac pathology * neurological pathology * chronic opioid treatment * any treatment interfering with the autonomic nervous system * any contraindication to nsaids

Keywords: pain postoperative tonsillectomy analgesia nociception index pupillary index pain
the effects of intrauterine infusion of hcg at the time of embryo transfer

Conditions: Infertility

Summary: the purpose of this study is to determine whether intrauterine hcg can improve the implantation rate and clinical pregnancy rate after embryo transfer in ivf/icsi cycle.

patients at infertility clinic, siriraj hospital who come to start ivf/icsi treatment cycle or endometrial preparation for embryo transfer are consiferes as eligible subjects. on the day of embryo transfer (both fresh and frozen-thaw cycle), the subjects will be randomized to 2 groups. 1. control group: embryo transfer after intrauterine infusion with standard embryo culture media 4-7 minutes 2. study group: embryo transfer after intrauterine infusion with hcg (pregnyl) 4-7 minutes the patients will come back for serum beta-hcg measurement 2 weeks later after embryo transfer and other 2 weeks later for transvaginal ultrasound if beta-hcg is positive.

Eligibility criteria:
inclusion criteria: 1. infertile women aged 18-43 years 2. indicated or willing for ivf/icsi treatment or endometrial preparation for embryo transfer exclusion criteria: 1. azoospermic male partner 2. failure to retrieve oocyte after controlled ovarian hyperstimulation 3. no embryo retrieved for transfer 4. endometrial preparation failure

Keywords: clinical pregnancy rate
postoperative vr for recovery after bariatric surgery

Conditions: Bariatric Surgery Candidate; Postoperative Pain; Postoperative Complications

Summary: the objective of this study is to investigate whether the addition of immersive virtual reality (vr) in the immediate postoperative period to an enhanced recovery after surgery (eras) protocol could improve postoperative recovery from bariatric surgery.

the investigators propose conducting a randomized, controlled, single-center clinical trial of patients recovering from laparoscopic bariatric surgery. the objective is to investigate whether the use of virtual reality (vr) during the immediate postoperative period could improve patient reported quality of recovery and potentially reduce opioid analgesic requirements as compared to an existing eras protocol. the investigators hypothesize that immersive vr will improve subjective quality of recovery scores at time of post anesthesia care unit (pacu) discharge as compared to standard eras.

Eligibility criteria:
inclusion criteria: - patients undergoing laparoscopic bariatric surgery at bidmc under general anesthesia. exclusion criteria: * age\<18 * open wounds or active infection of the face or eye area * history of seizures or other symptom linked to an epileptic condition * patients with hearing aids who are unable to tolerate wearing headphones with their hearing aids * patients with a pacemaker or other implanted medical device * droplet or airborne precautions (as determined by bidmc infection control policy) * non english speaking or non spanish speaking * chronic opioid dependence (existing oral opioid prescription for \>3 months, methadone, suboxone) drop out criteria: (after enrollment and randomization, before intervention) - surgery is converted to an open procedure (laparotomy), the patient will be withdrawn from the study as these patients are treated in a manner that is different than standard eras protocols

Keywords: virtual reality eras
a trial of an online mindfulness based programme for informal caregivers of people with chronic illnesses

Conditions: Chronic Illness

Summary: this is a pilot feasibility study testing a mindfulness based intervention with caregivers of people with chronic illnesses

the primary aim of the project is to pilot test the delivery of an online mindfulness based stress reduction (mbsr) programme to informal caregivers of people with chronic illnesses in one region in ireland so as to determine the feasibility of delivering the intervention to caregivers in ireland. a two-group randomised pilot-feasibility trial comparing the online mbsr programme (intervention) with no programme (control). the mbsr programme is delivered online over 8 weeks. weekly email and telephone contact will be maintained with participants in the intervention group for the duration of the delivery of the intervention. participants are encouraged to practice mindfulness exercises and homework between sessions. the online programme was developed by a trained mindfulness teacher and a mindfulness teacher will conduct the weekly email and telephone call to participants in the intervention group. the study sample are caregivers in the dublin region who are members of family carers' ireland. a total of 80 caregivers will be recruited to the study, 40 per group, based on 1:1 randomisation using a computer-randomised number generator. baseline (pre-intervention) and post intervention participant outcome data (stress, mindfulness and qol) will be collected using self-reported validated scales administered to participants by post, with stamped-addressed envelopes provided for return. other pilot measures (i.e. study processes) will be monitored and assessed by the research team to determine potential refinement needs. feasibility outcome data will be collected by the research team (including time to recruit, attendance at classes, willingness of participants to be randomised) and by the participants (expenses diary) during the study period, using predesigned data collection forms. mean differences with 95% confidence intervals will be calculated to determine any significant differences between the groups on the outcomes of stress, mindfulness and qol.

Eligibility criteria:
inclusion criteria: * be 18 years of age and over * provide unpaid care to an adult or child with a chronic illness * not suffer from a severe mental illness * be ready to commit to the course at this point in their lives. exclusion criteria: * caregivers who are under the age of 18 years. * caregivers who have a serious mental illness, such as severe anxiety/depression. * caregivers who are in receipt of current and regular treatment from a psychologist or psychiatrist. * caregivers with an active or recent physical addiction to alcohol or drugs. * caregivers who are already engaged in similar research. * caregivers who have already participated in mindfulness based stress reduction (mbsr) or mbct training.

Keywords: mindfulness caregivers
descriptive study of the incidence and outcome of pas in two large referral hospitals in egypt

Conditions: Placenta Accreta

Summary: placenta accreta spectrum incidence and outcome

placenta accreta spectrum ( pas ) one of the most serious condition in obstetrics nowadays so the investigators measure the incidence by this study

Eligibility criteria:
inclusion criteria: * gestational age above 28 weeks exclusion criteria: * age less than 18

Keywords: pas
post-discharge opioid reduction intervention for open, laparoscopic, and endoscopic surgery

Conditions: Prostate Cancer; Opioid Use

Summary: orioles is a non-randomized, pre-post intervention study designed to improve quality of opioid prescribing and use after discharge for patients undergoing urologic surgery. the study will initially focus on a pre-defined cohort of patients undergoing radical prostatectomy. after the predefined study period for the pre-intervention arm, a three-part intervention is employed to assess the effect on opioid prescribing and use in the post-intervention arm. pending results, the intervention may be applied to all surgeries in the department for routine clinical care.

the goal of the study is to reduce the amount of opioid analgesia prescribed after urologic surgery in the department of urology at johns hopkins. the initiative focuses on patients undergoing surgery for prostate cancer with radical prostatectomy including patients enrolled in irb00123618/nct03006562. the pre-intervention arm will consist of patients enrolled august 2017 to january 2018. the intervention arm will consist of patient enrolled january 2018 to completion of the study. the intervention consists of a information discharge sheet, a standardized prescribing guideline at discharge, and nurses providing improved education for patients at discharge about appropriate use of opioid medication, routes for disposal, and potential side effects. data on prescriptions written (amount and type of mediation) and use of opioid and other pain medication after surgery will be compared before and after the quality improvement initiative is started. outcomes are assessed via 30-day phone call follow-up with data on perioperative outcomes, postoperative medication use, and symptoms already assessed in irb00123618/nct03006562. at the completion of the pre-intervention arm, providers in the urology department are informed about the average and distribution of usage of post-discharge opioids. education and standardized prescribing (allowing for provider judgment) may help reduce/personalize the amount of opioids prescribed at discharge to reduce wasted medication entering circulation. the initiative may then be expanded to encompass all surgeries in the department to reduce opioid prescribing and use for routine clinical care.

Eligibility criteria:
inclusion criteria: * all patients diagnosed with prostate cancer and enrolled in nct03006562 exclusion criteria: * patients not undergoing radical prostatectomy (for the primary pre-post orioles study)
spinejack system postmarket registry

Conditions: Osteoporotic Vertebral Compression Fractures

Summary: this postmarket registry is intended to prospectively collect real world data to support ongoing safety and performance of the spinejack system.

the spinejack system registry will employ a prospective, multicenter, observational, consecutive enrollment design. the sample size for this registry will include at least 400 patients treated for vcfs across approximately 10 sites. a total of 240 patients will be treated with the spinejack system and 160 patients will be treated with other vertebral augmentation (va) procedures, such as bkp or vp. sites within the u.s. may include healthcare professionals (hcps) that are surgeons, pain physicians and/or interventional radiologists.

Eligibility criteria:
inclusion criteria: 1. 18 years of age or older 2. understand and sign the informed consent form (as applicable) 3. exhibit no altered mental status or language barrier that may prevent completion of the patient reported outcome (pro) surveys following the procedure. 4. vcf diagnosis made and/or confirmed at participating site. exclusion criteria: -
the influence of the vaginal microbiome on clinical pregnancy in patients undergoing a euploid embryo transfer: a prospective blinded multicentre cohort study

Conditions: Vaginal Microbiome

Summary: microorganisms such as bacteria live naturally on and in the bodies and are of great importance for our health. in the female body, almost 10% of all microorganisms live in the reproductive organs and especially in the vagina. healthy bacteria in the vagina can defend against harmful bacteria and infections. however, it occasionally happens that the balance between healthy and harmful bacteria is disturbed, and it is believed that this could potentially harm pregnancy. however, there is not much evidence to prove a connection between an imbalance in bacteria and having an unsuccessful pregnancy. for this reason, the goal of our study is to determine if women with certain vaginal bacteria are more likely to experience pregnancy failures. if the investigators find this to be true, patients undergoing fertility treatment might be recommended regular tests in the future. if an imbalance in bacteria is found, doctors could provide treatment to restore a healthy vaginal environment, potentially improving the chances of a successful pregnancy.


Eligibility criteria:
inclusion criteria: * art patients undergoing the transfer of a euploid embryo exclusion criteria: * patients with a body mass index (bmi) ≥35 * patients with uncorrected uterine malformations * patients with a unicornuate uterus * patients with a bicornuate uterus * patients with any type of submucosal myoma * patients with an intramural myoma if ≥4 cm * patients with severe adenomyosis (\>50% of the uterine corpus affected as defined by the musa criteria \[19\]) * patients undergoing transfer of an embryo with a morphology score \<4bc (according to the gardner \& schoolcraft scoring system \[18\]) * patients undergoing transfer of a day-7 embryo * patients who took antibiotics in the month prior to the embryo transfer (excluding antibiotics given following oocyte retrieval)

Keywords: female reproductive tract microbiome, vaginal dysbiosis
safety and efficacy of adderall xr in the treatment of adolescents aged 13-17 with attention deficit hyperactivity disorder (adhd)

Conditions: ADHD

Summary: assess the safety and efficacy of adderall xr compared to placebo in the treatment of adolescents (aged 13-17) with adhd. subjects were assigned to one of two cohorts based on weight (\ 75 kg).


Eligibility criteria:
inclusion criteria: * males/females 13-17 years of age meeting dsm-iv criteria for a primary diagnosis of adhd exclusion criteria: * controlled or uncontrolled comorbid psychiatric diagnosis (except odd) with significant symptoms such as ptsd, psychosis, bipolar disease, severe ocd * known non-responder to stimulant medication * documented allergy or intolerance to adderall, adderall xr or amphetamines * conduct disorder, hypertension, history of seizure * tic disorder or tourette's disorder
bioavailability of fatty acids from krill oil and krill meal and fatty acids from fish oil in healthy subjects.

Conditions: Healthy

Summary: the purpose of the study is to compare the acute bioavailability of two different krill oil products called krill oil and krill meal in comparison to fish oil product.


Eligibility criteria:
inclusion criteria: * healthy female and male * age 18 - 65 years * body mass index 18.5 - 30 * informed consent, signed exclusion criteria: * medication potential to affect the bioavailability of fatty acids (e.g. lipid-lowering drugs) * familial hypercholesterolemia, marked combined hyperlipidemia, condition that would impair, fat absorption (e.g. chronic pancreatitis, pancreatic lipase deficiency syndrome) * any untreated medical condition affecting absorption of fat * type 1 and 2 diabetes * cancer or other malignant disease within past five years * periodical hormone replacement therapy * high intake of oily fish (once a week or more) (i.e. salmon, herring, sardines, mackerel, vendace) * smoking * alcohol consumption \> 15 doses per week * females who are pregnant, breast-feeding or intend to become pregnant * hypersensitivity to any of the components of the test product * regular use of n-3 supplements 4 weeks before randomization * lack of suitability for participation in the trial, for any medical reason, as judged by the principal investigator
study of the safety and efficacy of moxidectin tablets for the reduction of demodex eyelash infestation

Conditions: Blepharitis

Summary: a single-center, investigator-masked, randomized, placebo-controlled, investigator initiated study of the safety and efficacy of moxidectin tablets for the reduction of demodex eyelash infestation


Eligibility criteria:
inclusion criteria: active blepharitis with collarettes - exclusion criteria:other clinically significant eye disease -

Keywords: blepharitis demodex
compassionate use of hyperbaric oxygen therapy

Conditions: COVID-19

Summary: this is an observational patient registry of covid-19 patients treated with hbot.

the retrospective analysis will focus on the reduction in need for mechanical ventilation in covid-19 patients. the information will be gathered prospectively. data will be collected from the patients' medical record, including medical notes and data recorded into the study database.

Eligibility criteria:
inclusion criteria: * adult patients with covid-19. * the clinical decision to use hbot is independent of the decision to participate in registry. * a signed and dated informed consent form for the off-label use of hyperbaric oxygen therapy specific to the institution where treatment is rendered. * subject is willing and able to comply with instructions and scheduled visits. exclusion criteria: * the subject has other concurrent conditions that in the opinion of the investigator may compromise patient safety. * the patient has an untreated pneumothorax.

Keywords: covid-19 mechanical ventilation hyperbaric oxygen therapy patient registry