Kornimate/medical-research-clean huggingface dataset:
a biobehavioral model of diabetes risk in chinese immigrants

Conditions: Diabetes Mellitus, Type 2

Summary: this prospective, longitudinal study of chinese american immigrants will examine whether psychosocial factors (e.g., acculturative stress, social isolation, discrimination) are associated with markers of type 2 diabetes risk over time, and whether such associations are mediated by inflammatory pathways.

it is now well-documented that immigration to the us leads to increased risk for various chronic diseases, including type 2 diabetes. the increased diabetes risk observed among chinese immigrants has been primarily attributed to changes in diet and weight gain following immigration, but these changes can only partially explain disparities in disease risk. models of immigrant health suggest that the stress of adapting to life in a new country has a considerable impact on physical health. however, few studies have considered the psychosocial impact of immigration upon biomarkers of health and disease risk. therefore, this longitudinal study of us chinese immigrant men and women will examine: (1) whether psychosocial factors (e.g., acculturative stress, social isolation, discrimination) are associated with markers of type 2 diabetes risk over time; and (2) whether the association between psychosocial factors and diabetes risk markers is mediated by inflammatory pathways.

Eligibility criteria:
inclusion criteria: * chinese heritage; * migration from asia in adulthood (aged 18 years or older); and * age 35-65 years exclusion criteria: * current or prior history of diabetes * self-reported conditions of cancer, auto-immune disorders, hiv, or psychiatric illness * use of medications that may impact study outcomes (e.g., steroidal or non-steroidal anti-inflammatory medications) * inability to provide informed consent.
dbs virtual learning experience

Conditions: Parkinson Disease

Summary: the success of deep brain stimulation (dbs) is more correlated to fulfillment of patients' expectations, than merely improvement of motor status1. therefore, it is of utmost importance to inform the dbs candidates as good as possible to set realistic expectations. currently, the patient - most of the time accompanied by a family member - is informed about the surgery and its benefits and risks during the outpatient consultation of the neurologist, and later on during the consultation of the neurosurgeon. written information is provided in the form of a booklet that the patients take home. due to the large amount of information, not all of it can be captured by the patient. therefore, we would like to investigate whether an additional online immersive educational session on dbs would better educate the patient. the online session is a 1-hour video call with a small group of dbs candidates and their caregivers, lead by dbs experts, where testimonials of other patients are shown, together with multiple infographics. two weeks later their will be a second online session summarizing the information and providing the opportunity for q\&a.


Eligibility criteria:
inclusion criteria: 1. patients of any age over 18 who are capable of understanding and granting informed consent. 2. consecutive enrollment of parkinson's disease patients, eligible for dbs surgery who will be operated in toronto western hospital. 3. targets of surgery (stn or gpi) equally in each study arm. 4. patients must be able to follow the assessment procedure. exclusion criteria: 1. people with limited digital skills (to the discretion of the pi).
the impact of lingual frenotomy on bottle feeding mechanics

Conditions: Ankyloglossia; Feeding, Bottle; Feeding Disorder of Infancy and Childhood

Summary: conservative estimates show that 3-5% of all infants have tongue tie. these studies only focus on visible, anterior tongue tie. deeper, more visibly subtle cases of ankyloglossia have not been included in these incidence numbers, so the percentage of children with ankyloglossia is much higher than previously thought. previous research by the investigators demonstrates that posterior tongue tie can be as problematic as anterior ties. an available fda-approved feeding solution allows for the measurement of infant sucking motions. this allows for detection of changes following surgical intervention. previous ultrasound studies show the importance of the upward movement of the tongue, but further lingual movement parameters following frenotomy have not been reported. the primary goal of this study is to record changes in lingual movement following lingual frenotomy. the investigators plan to compare improvements over time between a control, non-intervention group and a frenotomy group. secondary goals include recording validated outcomes of reflux and feeding efficiency.


Eligibility criteria:
inclusion criteria: * babies who are already fully or partially bottlefeeding * have already worked with lactation consultant prior to appointment * diagnosis of tongue tie exclusion criteria: * severe neurologic/cardiac/pulmonary comorbid diseases * twins/triplets * other oral pathology (ie cleft lip/palate)

Keywords: tongue tie ankyloglossia infant feeding bottle feeding
safety and efficacy of fenofibrate as a treatment for huntington's disease

Conditions: Huntington Disease

Summary: the purpose of this research study is to study the safety and efficacy of fenofibrate, an fda-approved drug for high cholesterol and/or elevated triglycerides (fats), as a treatment for huntington's disease (hd). subjects who meet the entry criteria will be randomized (3:1) to either 145mg of fenofibrate or placebo.


Eligibility criteria:
inclusion criteria: * an adult of either sex, ages 25-85 inclusive, * have proficiency with written and spoken english and corrected vision or hearing to complete the cognitive testing, * are able to give informed consent, * have good overall health status with no known problems anticipated over the course of the trial, * have a diagnosis of hd supported by positive gene test within the past 6 months. exclusion criteria: * other major neurological disease \[e.g., multiple sclerosis, parkinson's disease, cortical stroke, etc\] * clinically significant hepatic or renal disease, * current or recent (\< 1 month) use of dopamine blocking agents such as tetrabenazine, anticonvulsants, neuroleptics, haart, antiemetics, and antipsychotics for any reason, * current use of warfarin (coumadin). enrollment in another investigational drug study within the prior three months.
phase 2 study of montelukast for the treatment of sickle cell anemia

Conditions: Sickle Cell Anemia (HbSS, or HbSβ-thalassemia0)

Summary: in this feasibility trial, the investigators will compare participants treated with montelukast and hydroxyurea to those treated with placebo and hydroxyurea for a total of 8 weeks.

the primary hypothesis for this trial is that montelukast adds efficacy to hydroxyurea therapy for improving vaso-occlusion when compared to hydroxyurea alone. the following specific aims will be tested in adolescents and adults with sickle cell disease (scd): aim 1. to determine whether montelukast versus placebo added to hydroxyurea will improve markers of vaso-occlusion-associated tissue injury in adolescents and adults with sickle cell disease. aim 2. to evaluate physiologic effects of montelukast versus placebo added to hydroxyurea in adolescents and adults with sickle cell disease. subaim 2a. to determine if montelukast versus placebo added to hydroxyurea will improve lung function in adolescents and adults with sickle cell disease. subaim 2b. to determine if montelukast versus placebo added to hydroxyurea will improve forearm microvascular blood flow in adolescents and adults with sickle cell disease, respectively. funding source - fda oopd

Eligibility criteria:
inclusion criteria: * 1)diagnosis of hbss, or hbsβ-thalassemia0, confirmed by hemoglobin analysis * 2)males and females age 16 years to 70 years old * 3)greater than 2 episodes of pain in the last 12 months * 4)on a stable dose of hydroxyurea for at least 2 months and a stable hemoglobin exclusion criteria: 1. judged not likely to be study compliant by his/her hematologist 2. history of adverse reaction to montelukast or any of the components of montelukast 3. have used medications known to interact with montelukast such as rifampin, phenobarbital, and gemfibrozil within 4 weeks of enrollment 4. currently being treated with a leukotriene antagonist (montelukast or zileuton) or have used montelukast/zileuton within the last 60 days 5. chronic blood transfusion therapy defined as regularly scheduled transfusions. 6. hemoglobin a greater than15% on hemoglobin analysis 7. individuals with a current physician diagnosis of asthma (within last 12 months) or requires continuous supplemental oxygen, or predicted or current use of asthma medications (inhaled corticosteroids, but participants taking bronchodilators will be allowed to participate). 8. current participation in another therapeutic trial for scd 9. known current pregnancy 10. known history of hiv 11. serum creatinine greater than 3 times the site's upper limit of normal
comparison of glucose values and variability between toujeo and tresiba during continuous glucose monitoring in type 1 diabetes patients

Conditions: Type 1 Diabetes Mellitus

Summary: primary objective: to demonstrate the non-inferiority of insulin glargine 300 units per milliliter (u/ml) in comparison to insulin degludec 100 u/ml on glycemic control and variability in participants with diabetes mellitus. secondary objective: to evaluate the glycemic control and variability parameters in each treatment group at week 12 using continuous glucose monitoring. to evaluate the safety of insulin glargine 300 u/ml in comparison to insulin degludec 100 u/ml.

the duration of the study per participant was around 18 weeks: 1 or 2 weeks of screening followed by a 4-week run-in period, a 12-week treatment period and a 2 to 4 days follow-up period.

Eligibility criteria:
inclusion criteria : * participants with type 1 diabetes mellitus. * participants treated with multiple daily injections using basal insulin analog once daily and rapid acting insulin analogs for at least one year. * hba1c greater than or equal to (\>=) 7 percent (%) (53 millimoles per mole \[mmol/mol\]) and less than or equal to (\<=) 10% (86 mmol/mol) at screening. exclusion criteria: * participants not on stable dose of basal insulin analog. * participants having received toujeo or tresiba as basal insulin within 30 days prior to screening. * participants not having used the same insulins (both basal and rapid) within 30 days prior to screening. * participants having received basal insulin dose \>= 0.6 units per kilogram body weight within 30 days prior to screening. * participants having received any glucose lowering drugs (including any premixed insulins, human regular insulin as mealtime insulins, any others injectable or oral), other than basal and rapid insulin analogs, within 3 months prior to screening. * end stage renal disease or on renal replacement treatment. * retinopathy or maculopathy with one of the following treatments, either recent (within 3 months prior to screening) or planned: intravitreal injections or laser or vitrectomy surgery. * body weight change \>=5 kilogram within 3 months prior to screening. the above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
trial comparing complication rates associated with robot-assisted thyroidectomy to external thyroidectomy

Conditions: Thyroid Nodule; Goiter; Thyroiditis; Graves Disease

Summary: the main objective is to compare 12 month complication rates between a new surgical method for thyroidectomy (robot-assisted endoscopic thyroidectomy via a sub-clavical approach) and open thyroidectomy.


Eligibility criteria:
inclusion criteria: * the patient must have given his/her informed and signed consent * the patient must be insured or beneficiary of a health insurance plan * the patient is available for 12 months of follow-up * the patient is a candidate for total thyroidectomy because of a nodular pathology, a diffuse goiter, thyroiditis, or basedow's disease * patient has calcitoninemia \< 9 ng/pl * patient has normal calcemia * patient has pth level between 5 ng/l and 75 ng/l * the subject has a normal laryngeal mobility exclusion criteria: * the patient is participating in another study * the patient is in an exclusion period determined by a previous study * the patient is under judicial protection, under tutorship or curatorship * the patient refuses to sign the consent * it is impossible to correctly inform the patient * the patient is pregnant * the patient is breastfeeding * the patient is not available for 12 months of follow-up * subject has a preoperative diagnosis of cancer on fine needle aspiration biopsy of the thyroid or cervical lymph node * lymph node metastasis strongly suspected clinically and/or sonographically * the subject has an extension of substernal thyroid (diving goiter) * family history of medullary thyroid cancer * the subject has a history of neck surgery * contraindication for general anesthesia

Keywords: da vinci robot thyroidectomy
comparing the use of a mobile app for surveillance of adverse events following influenza immunization to a web-based platform

Conditions: Mobile Apps; Immunization; Adverse Event Following Immunisation

Summary: methods study procedures a two-centred randomized control trial (rct) was conducted to evaluate the use of safety reporting via a mobile app compared to safety reporting via web-based canvas notifications amongst individuals receiving the influenza vaccine from october 6 to november 29, 2020 during the seasonal influenza vaccine campaign in ottawa and vancouver, canada. individuals were recruited at the time of receiving their influenza vaccine. eligibility criteria included the ability to speak english or french, having an active email address and telephone number, and being immunized with the seasonal influenza vaccine. randomization after study enrollment, participants were randomized to receive the online safety survey either through the mobile app or emailed a link to the online survey using a four-block randomization design. web-based notification arm all participants randomized to the web-based notification arm received the following web-based canvas notifications. briefly, participants received an email notifying them of their registration in the study. eight days following their influenza vaccine, participants received an email with the survey link asking them to complete their online influenza vaccine safety survey. participants received a reminder email on day 11 if they did not complete their survey. further details on canvas surveillance and description of the questionnaire can be found here. mobile app arm participants randomized to the mobile app arm, received an email asking them to download the app and activate their account. users who did not activate their account after 48 hours received a reminder email. participants who activated their accounts, could spontaneously report an adverse event through the app, and were also notified of the day 8 survey through the app. eight days following their vaccination mobile app participants who activated their account received a push notification on their phone to complete their survey. a reminder push notice was sent out on day 11 to participants that had not yet competed the day 8 survey. on november 16, 2020 (mid-way through the recruitment period), additional email reminders in the mobile app arm were implemented on days 2, 4 and 6 to remind participants to register for the app. all participants received a day 8 email directing them to use their canimmunize account to complete their influenza vaccine survey. access to the survey link also was available in the email reminder.


Eligibility criteria:
inclusion criteria: * speak english or french, * have an active email address and telephone • immunized with the seasonal influenza vaccine * parents of children are eligible to participate after the first or second dose of vaccine exclusion criteria: * those who do not meet the inclusion criteria
the valve of hyaluronic binding selection (picsi) in improving ivf outcome

Conditions: Infertility

Summary: the investigators would like to assess whether selecting mature sperm using picsi (selecting for sperm that bind hyaluronan) can optimize the ivf outcome of icsi . aim 1. primary outcome: to compare routine sperm selection using icsi with sperm selection using picsi plates in terms of implantation and fertilization rates for couples with male factor fertility 2. secondary outcome : to compare live birth rates ,ongoing pregnancies and miscarriage rates for couples with male factor infertility using routine sperm selection with icsi compared to using picsi plates for sperm selection hypothesis: sperm selected for icsi using (picsi) will reveal increased implantation rates in comparison to sperm selected for conventional icsi


Eligibility criteria:
inclusion criteria: * in order to participate in the study women must be 42 years old or younger and suffer from male factor infertility however they may have other causes for their infertility * male factor infertility as defined by one or more of the following sperm parameters: \<20 million /ml sperm concentration \< 30% normal morphology \< 3% kruger morphology \< 50% motility sion criteria:
autologous hematopoietic stem cell transplantation in pediatric relapsed or refractory hodgkin lymphoma after nivolumab treatment

Conditions: Relapsed or Refractory Hodgkin Lymphoma; Children; Nivolumab; Autologous Haemopoietic Stem Cell Transplant

Summary: children with relapsed or refractory hodgkin lymphoma receive 3-6 cycles of nivolumab monotherapy. in case of achieving complete response (cr) auto-hsct is performed. in the absence of cr, 3-6 additional cycles of nivolumab with bendamustine are administered. if complete or partial response is achieved, auto-hsct is performed.


Eligibility criteria:
inclusion criteria: * diagnosis of hodgkin lymphoma established on the basis of histological and immunohistochemical studies * confirmation of relapsed of refractory hodgkin lymphoma based on histological and immunohistochemical studies or based on imaging methods (pet/ct and/or ct). * number of previous lines of therapy \>2 * karnofsky index ≥60% * availability of signed informed consent - exclusion criteria: * number of previous lines of therapy ≤ 2 * karnofsky index \< 60 * intolerance to drugs used in the study * presence of a second tumor * pregnancy or lactation * participation in another study within six months * presence of concomitant severe disease * presence of hiv and/or viral hepatitis (b or c)
efficacy and safety of probiotics in the treatment of acute gastroenteritis in children

Conditions: Acute Gastroenteritis

Summary: * primary objective: o to assess the efficacy of the probiotics in reducing the duration of diarrhea in children suffering from acute gastroenteritis. * secondary objectives: * to assess the efficacy of the probiotics in improving the frequency and consistency of stools. * to assess the efficacy of the probiotics in avoiding recurrence of diarrhea. * to assess the efficacy of the probiotics on the disease severity. * to assess the safety and tolerability of the studied probiotics.


Eligibility criteria:
inclusion criteria: * children of both gender aged between 6 months and 5 years * presenting with acute diarrhea (3 or more loose or liquid stools in a 24-hour period) since at least the last 24h but less than 5 days * signed informed consent of the legal representatives obtained before any study procedure * parents able to fulfill in the stool diary according to the physician's opinion. exclusion criteria: * unable to take medication and fluids by mouth * more than 50% breastfeeding * severe malnutrition, defined by a ratio weight/height at/or below -3sd * severe dehydration, defined by a need of iv rehydration * chronic underlying disease, including but not limited to severe gastrointestinal disorder, immunocompromised condition or systemic infection * use of prohibited treatments * contra-indications to the studied probiotics
orthorexia nervosa in postmenopausal osteoporosis

Conditions: Osteoporosis

Summary: a total of 64 female patients diagnosed with osteoporosis based on dual-energy x-ray absorptiometry (dxa) measurements performed within the last six months, and 64 age-matched healthy controls without osteoporosis, will be included in our study. sociodemographic data such as age, sex, height, weight, and bmi will be recorded. additionally, information regarding the duration of osteoporosis diagnosis, current treatments, history of fractures, history of falls, comorbidities, and smoking status will be collected. femoral neck and l1-l4 t-scores and bone mineral density values obtained from existing dxa scans will be documented. orthorexia nervosa-related symptoms will be assessed using the orto-11 scale, mood will be evaluated using the hospital anxiety and depression scale (hads), and body image will be assessed using the body appreciation scale-2.


Eligibility criteria:
inclusion criteria: * women between 55-75 years * women diagnosed with osteoporosis based on dxa measurements performed within the past six months. * women aged similarly to the osteoporosis group without a diagnosis of osteoporosis (healthy controls). * willingness to participate and provision of written informed consent. exclusion criteria: * refusal to participate in the study. * diagnosed psychiatric disorders. * cognitive impairment. * presence of malignancy. * presence of endocrine disorders (e.g., hyperthyroidism, cushing's syndrome). * use of glucocorticoids. * use of medications affecting mood.