Kornimate/medical-research-clean huggingface dataset:
predicting response to incretin based agents in type 2 diabetes

Conditions: Type2 Diabetes

Summary: type 2 diabetes is a major and rapidly increasing health problem worldwide. keeping the blood glucose (sugar) from going too high helps prevent complications. recently a number of new treatments (collectively called 'incretin based' treatments) to lower blood glucose have become available but response is very variable and it is difficult to predict which will work for an individual. the investigators want to see if we can identify whether the new treatments are likely to be effective for an individual patient. identifying the right treatment would improve control and minimise the side-effects and costs from ineffective treatments. we will collect blood (for measures of blood glucose, insulin secretion and genetics information), urine (for a simple measurement of insulin secretion) and other clinical information (such as weight,age, duration of diabetes and medication) in people who are about to start these new 'incretin based' treatments and assess their response over the first 6 months of treatment. we will analyse this information to see if we can predict treatment response. study hypothesis: the investigators hypothesise that those who have low insulin secretion, as measured by post meal urine c-peptide creatinine ratio or blood c-peptide, will have poor blood glucose response to incretin based treatments.


Eligibility criteria:
inclusion criteria: * a clinical diagnosis of type 2 diabetes mellitus where the patient's clinician has determined the need for a dpp-iv inhibitor or glp-1 analogue as a result of inadequate glycaemic control * hba1c \>= 58mmol/mol exclusion criteria: * treatment with dpp-iv inhibitors or glp-1 analogues prior to study initiation (within the previous 3 months) * renal failure as shown by a egfr (estimated glomerular filtration rate) less than 30 ml/min/1.73m2

Keywords: glucagon-like peptide 1, dpp4 protein, therapeutics, hypoglycemic agents, c-peptide, type 2 diabetes mellitus,
the effect of goal-directed hemodynamic therapy in radical cystectomy

Conditions: Bladder Cancer; Radical Cystectomy

Summary: goal-directed therapy (gdt) has been applied to various clinical settings and has been widely researched recently as a method for perioperative management of patients. radical cystectomy is a complex surgical procedure in which the bladder is removed, followed by urinary diversion. it is an extensive and time-consuming intervention and has high probability of fluid imbalance and bleeding during surgery. we hypothesized that the application of gdt in these patients would improve clinical postoperative outcomes. therefore, we will attempt to evaluate improvement of postoperative outcomes after applying gdt protocol based on changes in stroke volume index, cardiac index and mean arterial pressure in radical cystectomy.


Eligibility criteria:
inclusion criteria: * patients undergoing open radical cystectomy * patients with american society of anesthesiologists physical status i-iii exclusion criteria: * significant hepatic dysfunction, significant renal dysfunction (estimated glomerular filtration rate \<60 ml/min) * congestive heart failure (new york heart association scores ≥3), left ventricular ejection fraction \< 35% * arrhythmia * coagulopathy (pt inr \>1.5)

Keywords: goal-directed therapy stroke volume index
correlation between core temperature and skin temperature in pediatrics

Conditions: Temperature Change, Body; Anesthesia; Children, Only

Summary: during general anesthesia, temperature monitoring is critical especially in pediatrics. recently developed 3m™ bair hugger™ skin temperature which is applied on temporal artery is correlated with core temperature measure by esophageal prove in several studies. conventional skin temperature over carotid artery is also correlated with core temperature in several studies. the purpose of this study is comparing 2 methods of temperature monitoring in pediatrics. first, conventional core temperature measure by esophageal stethoscope. second, 3m™ bair hugger™ applying on carotid artery.

core temperature should be monitored under general anesthesia. because patients are prone to hypothermia during surgery, besides, pediatric patients are more vulnerable in temperature control. conventional core temperature is monitored at esophagus, rectum, nasopharynx. but some of them are invasive and impossible in sometimes. recently developed 3m™ bair hugger™ skin temperature which is applied on temporal artery is correlated with core temperature measured by esophageal prove in several studies. its mechanism is making zero heat flux on skin applied. but it also cannot apply in head or facial surgery. other studies showed conventional skin temperature over carotid artery is also correlated with core temperature. the investigators hypothesized using 3m™ bair hugger™ on carotid artery could be alternative method measuring core temperature. the purpose of this study is comparing 2 methods of temperature monitoring in pediatrics. first, conventional core temperature measure by esophageal stethoscope. second, 3m™ bair hugger™ applying on carotid artery.

Eligibility criteria:
inclusion criteria: * scheduled operation under general anesthesia * who need esophageal temperature monitoring * american society of anesthesiology physical status 1 or 2 exclusion criteria: * body mass index \> 35 kg/m2 * who cannot be inserted esophageal temperature prove * patients with fever \> 38'c * history of malignant hyperthermia

Keywords: pediatric temperature general anesthesia
effects of a lower back wrap device on lower back pain, physical function, and quality of life

Conditions: Lower Back Pain; Lower Back Pain Chronic; Acute Low Back Pain

Summary: the goal of this counterbalanced cross-over study is to determine whether a recovery lumbar wrap effectively reduces lower back pain and improves outcomes related to physical function and quality of life in adults with lbp in adults 20-65 years old. this study will also explore whether improvements in other health metrics that are typically related to, or seen in, lower back pain research (i.e. stiffness, mobility, physical activity, validated clinical scoring methods, etc.) are improved with the use of the product. the main question this study aims to answer is: • does the lumbar wrap effectively reduce low back pain symptoms and improve outcomes related to physical function and quality of life in adults with lower back pain. participants experiencing lower back pain will be asked to use the lower back wrap for at least 20-minutes per day for a 2-week period, counterbalanced with a 2-week period of no device use. participants will fill out small daily surveys about their symptoms and complete a pre-, middle-, and post- survey and functional screening to determine efficacy of the device.

participants with both acute and chronic low back pain will be recruited from the emergency department, research registry, social media, and e-mails. participants will be screened for inclusion and exclusion criteria and consented. this study utilizes a counterbalanced cross-over design. each participant will complete both conditions: 1) intervention (wrap), or 2) control (nothing). a counterbalanced assignment approach will be used to determine the starting condition for each participant (phase 1). after completion of phase 1, each participant will complete the remaining condition for phase 2. each phase of the intervention will take 2 weeks, for a total of 4 weeks (2 weeks in phase 1, 2 weeks in phase 2). when participants are in the intervention phase of the study, they will be asked to use the lower back wrap at least once per day for the standard treatment length (20 minutes). to support ecological validity, participants will be able to use the device ad libitum (several times throughout the day) as desired. the researchers will administer simple daily surveys to log compliance to treatment. a pre-, mid-, and post- survey and functional screening will be conducted to gather additional information about the participant and device efficacy and use.

Eligibility criteria:
inclusion criteria: * adults aged 20 - 65 * males and females (50-50 split or close) * range of ethnicities * range of bmis exclusion criteria: * those with diagnosed cancer, infection, trauma, or lbp requiring surgical intervention * those currently undergoing rehabilitation treatment for lbp * those with other diagnosed conditions that may preclude them from safely participating * pregnant women * waist less than 26" or greater than 66" due to device limitations

Keywords: low back pain acute low back pain symptom reduction pain sensation
def-315 better accuracy in ejection fraction (ef) assessment with definity

Conditions: Cardiac Disease

Summary: this is a phase 3, prospective, open-label, multicenter study to evaluate left ventricular ejection fraction (lvef) measurement accuracy and reproducibility of definity® contrast-enhanced and unenhanced echocardiography as compared with non-contrast cardiac magnetic resonance imaging (cmr) used as the truth standard.


Eligibility criteria:
inclusion criteria: 1. men and women ≥ 18 years of age in sinus rhythm 2. able to communicate effectively with trial personnel 3. lvef measurements obtained via 2d echo with or without contrast obtained within 6 months prior to enrollment (day 0) 4. has provided signed informed consent after receiving a verbal and written explanation of this clinical trial exclusion criteria: 1. female subjects who are pregnant or lactating. all women of child bearing potential \[wocbp\] must have a negative urine pregnancy test at screening regardless of contraceptive use history. 2. women of child-bearing potential are excluded unless they: 1. are post-menopausal defined as amenorrhea ≥ 12 consecutive months, or 2. have undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy), or 3. have been using an adequate and medically approved method of contraception to avoid pregnancy for at least 1 month prior to definity® dose administration and be willing to continue using the same method for the duration of the study. 3. current illness or pathology that would prevent undergoing investigational product administration due to a significant safety risk to the patient. 4. uncontrolled arterial hypertension (defined as systolic blood pressure ≥ 200 mmhg or diastolic blood pressure ≥ 110 mmhg) or arterial hypotension (defined as systolic blood pressure ≤ 90 mmhg). 5. unstable cardiovascular status defined as: 1. myocardial infarction or unstable angina pectoris within 6 months prior to enrollment/definity® dose administration day 2. transient ischemic attack or stroke within 3 months prior to definity® dose administration 3. symptomatic valvular heart disease or moderate to severe stenotic valvular heart disease 4. clinically significant congenital heart defects 5. current uncontrolled cardiac arrhythmias causing symptoms or hemodynamic compromise 6. acute pulmonary embolus or pulmonary infarction 7. acute myocarditis or pericarditis 8. acute aortic dissection 9. atrial fibrillation 6. any major surgery within 4 weeks prior to screening 7. known contraindications to undergoing cmr (e.g. implanted pacemakers, cardioverter, defibrillators) or claustrophobia 8. participation in any investigational drug, device, or placebo study within 30 days prior to screening 9. known hypersensitivity to perflutren, or any of the excipients in definity® 10. prisoners or those who are subject to compulsory detention or involuntary incarceration for treatment of either a psychiatric or physical illness (e.g., infectious disease).

Keywords: left ventricular ejection fraction definity® enhanced echocardiogram cardiac magnetic resonance
telerehabilitation based on otago exercises for older adults

Conditions: Older Adults

Summary: this study is a single-blind, randomized controlled, prospective clinical trial. at least 62 older adults aged 65 and over were included in the study. evaluations were made twice, before starting the study and after completion. otago exercise program based on telerehabilitation was applied to the intervention group for a total of 21 sessions, 7 days a week for 3 weeks. the control group did not participate in any exercise program during the study period; however, it was reported that they could be included in the otago exercise program at the end of the study.

sociodemographic data and information about falling were recorded. edmonton frail scale, modified fall efficiency scale, five-dimensional european quality of life scale-5d-3l, timed up and go test, four-step balance test and 30 sec sit to standtest were applied to all older adults. evaluations were applied at the beginning and end of the study. a total of 21 sessions of otago exercise program were applied to the intervention group, 30 minutes/session, 7 days/week for 3 weeks. a printed physical activity recommendation brochure prepared for the older adults by the ministry of health of the republic of turkey was distributed to both groups. the older adults in the control group did not participate in any exercise program during the study period.

Eligibility criteria:
inclusion criteria for intervention group: * sedentary and sedentary older adults who do not have any neurological, cognitive, or communication problems that may affect assessments, and who volunteer to participate in the study. inclusion criteria for control group: * not participating in any exercise program during the study, not having any neurological, cognitive and communication problems that may prevent completing the assessments. exclusion criteria for intervention group: * participants who have communication problems, are younger than 65 years old, have any neurological diagnosis and have orthopedic, mental and communication problems that prevent evaluations, and do not consent to participate in the study. exclusion criteria for control group: * those who do not meet the specified age criteria for the study, fail to complete the assessments, and continue the rehabilitation program.
regional partnership for pregnant women at risk of substance misuse and their newborns

Conditions: Substance Use

Summary: this study recruits pregnant women and new mothers who are at risk of substance use concerns during pregnancy or delivery. these women are followed for 6 months and randomized into two groups; they may receive services as usual, or enhanced services. enhanced services include evidence based interventions and case management to support referrals to substance abuse treatment, and to teach strategies specifically targeted to parenting newborns.

the dual goals of this project are to (i) improve communication and collaboration between substance abuse treatment providers, obstetricians, and child welfare providers, and (ii) to enhance child welfare outcomes for pregnant women who are at risk of substance misuse and their babies. there is a particular need for a partnership in this area as new york state implements the 2016 comprehensive addiction and recovery act (cara) legislation, which focuses on a multi-agency approach to the problem of substance abuse for families at risk of child welfare involvement. services are delivered through montefiore's department of obstetrics \& gynecology and women's health (obstetrics). mothers-to-be who have screened at risk or tested positive for substances will be randomly assigned to receive services as usual as part of the comparison group, or to receive enhanced prenatal services as part of the program group. program services include 3 empirically supported interventions: motivational enhancement to enhance intrinsic motivation to change unhealthy behaviors and support their referral to substance abuse treatment; incredible years to improve parenting skills, especially related to infancy and early childhood; and contingency management to reinforce healthy behaviors, including attendance at treatment and abstinence. women enrolled into the study are randomly assigned into a program or comparison group. parent, child, and family outcomes are evaluated using self-report and administrative data.

Eligibility criteria:
inclusion criteria: -the potential subject: (i) is a woman who receives prenatal care at montefiore medical center, (ii) is at least 16 weeks pregnant and at most 12 weeks post-partum, and (iii) is identified as at-risk for substance use, and/or has tested positive for at least one substance. exclusion criteria: * minors * those who are less than 16 weeks pregnant or more than 12 weeks post-partum
association between a biological pattern of dysregulation of the hpa axis and mental disorders in children exposed to early life stress

Conditions: Mental Disorder, Child

Summary: the purpose of this study is to demonstrate an association between a biological pattern of dysregulation of the hpa axis and mental disorders in children exposed to early life stress.

the purpose of this study is to demonstrate an association between a biological pattern of dysregulation of the hpa axis and mental disorders in children exposed to early life stress. cortisol secretion lead to define two groups : pathologic versus normal cortisol secretion. mental disorders is evaluate with mini-kids ii (a mental health questionary) and lead to define two groups : mental disorders versus no mental disorders

Eligibility criteria:
inclusion criteria: * aged 8 to over 10 years * to be entrust to ase of finistère in stable environment (the same place of residence since 6 months or more) * french speaking * oral consent by children * informed and signed consent by tenured of parent authority exclusion criteria: * don't want to participate * to have chronic neurologic or endocrinal pathology or don't have access to verbal language.
point of care, high resolution and 3-dimensional ultrasonography

Conditions: Bone Loss in Jaw; Dental Diseases

Summary: the overall purpose of this study is to establish an ultrasound technique to aid in oral and dental examination of soft and hard tissues. ultrasound is currently not used in dentistry and associated oral examinations and we are exploring its usefulness for clinical practice. this study will investigate the use of ultrasonic imaging for planning and placing dental implants, as well as evaluate the use of ultrasonic imaging for monitoring marginal bone loss around dental implants.


Eligibility criteria:
inclusion criteria: * aged 18 years or older * • have a dental implant infection (bleeding on probing/exudate and probing depths of at least 5 mm) and are or will be scheduled for revision surgery within 90 days of the screening visit. * willing to comply with all study procedures and be available for the duration of the study. exclusion criteria: * unwilling or unable to read and sign informed consent form. * pregnancy or unsure of their pregnancy status (self-reported)
evaluation of implant stability in low quality bone following the use of osseodensifiers versus ridge expanders

Conditions: Low Bone Density

Summary: the use of osseodensification technique compared to ridge expansion screws in low bone quality

using densah burs in preparation of implant osteotomy compared to ridge expansion screws in low quality bone

Eligibility criteria:
inclusion criteria: * • single tooth missing in the maxillary region with d3 (350-850 hu) and d4 (150-350 hu) bone (sultana et al., 2020). * a minimum of 4 mm residual buccolingual bone width at site of implant placement (koutouzis et al., 2019). * the recipient site of the implant should be free from any pathological conditions. * no diagnosed bone disease or medication known to affect bone metabolism. * patients who are cooperative, motivated and hygiene conscious. * patients having adequate inter-occlusal space of 8-10 mm (fernández et al., 2017) exclusion criteria: * systemic conditions/diseases that contraindicate surgery (jarikian et al., 2021). * patients who have any habits that might jeopardize the osseointegration process, such as current smokers (vollmer et al., 2020). * patients with parafunctional habits that produce overload on implant, such as bruxism and clenching (sultana et al., 2020). * alcohol or drug abuse (ibrahim et al., 2020). * pregnant and lactating women.

Keywords: osseodensification ridge expansion screw
ice plant intensive cream for the prevention of hand-foot syndrome in breast cancer: pilot randomized controlled trial

Conditions: Hand-Foot Syndrome; Breast Cancer

Summary: the present pilot study investigates the feasibility of a prospective larger confirmatory study on the efficacy of dr. hauschka med ice plant intensive cream for the prevention of hand-foot syndrome in patients with breast carcinoma undergoing therapy with doxorubicin and / or docetaxel.


Eligibility criteria:
inclusion criteria: * breast cancer patients * therapy with doxorubicin and/or docetaxel * karnofsky performance status scale \> 80 * informed consent exclusion criteria: * patients with previous skin disease and/or polyneuropathy * intolerance or allergic reaction on at least one ingredient of ice plant intensive cream * already receiving chemotherapy * usage of ice plant intensive cream before trial * severe physical or psychological illness due to which the patient is not able to participate in the study * lack of german language skills
an epidemiological study to assess performance of using healthcare tools to understand genital herpes simplex virus-2 (hsv-2) in patients ≥ 18 years of age in the united states and europe.

Conditions: Herpes Genitalis

Summary: the aim of this study is to assess performance of using healthcare tools to understand genital herpes simplex virus-2 (hsv-2) in patients ≥ 18 years of age in the united states and europe. more specifically, the study aims to evaluate patient-reported outcome and quality-of-life endpoints as well as the performance study procedures in a decentralised setting. ultimately, this study will allow generating additional real-world evidence (rwe) on patterns of recurrences and other key parameters.


Eligibility criteria:
inclusion criteria: * man or woman ≥18 years old. * written informed consent obtained from the patient prior to performance of any study-specific procedure. * history of at least one episode of hsv-2 genital herpes lesions in the 12 months preceding the screening, and seropositive for hsv-2 as determined by western blot or pcr-positive for hsv-2 (newly diagnosed patients). * patients who are medically stable in the opinion of the investigator. * patients who, in the opinion of the investigator, are able to understand and comply with the study requirements (attend regular telephone calls/study site visits/home visits/self-completion of questionnaires, self-swabbing). * seronegative for hiv, as determined by laboratory testing. patients documented to be positive to hiv will not be eligible for study participation exclusion criteria: * prior receipt of a vaccine or candidate vaccine containing hsv antigens. * immunocompromised patients, as per medical history and investigator judgement. * other genital tract disorders or sexually transmitted diseases that may interfere with the assessment of the study (as per investigator's judgement).

Keywords: herpes simplex virus-2 hsv-2 genital herpes hsv-2 recurrence