Kornimate/medical-research-clean huggingface dataset:
a study to examine the effects of exenatide once-weekly injection on glucose control and safety in asian subjects

Conditions: Type 2 Diabetes Mellitus

Summary: previous studies have suggested that a once-weekly formulation of exenatide may provide sustained glycemic control. these previous studies of exenatide once weekly have been conducted in non-asian populations, so this study has been developed to support the local regulatory requirements of china, korea, japan, india, and taiwan.


Eligibility criteria:
inclusion criteria: * have been diagnosed with type 2 diabetes. * have suboptimal glycemic control as evidenced by an hba1c between 7.1% and 11.0% inclusive. * have a body mass index (bmi) of \>21 kg/m2 and \<35 kg/m2, inclusive. * have a history of stable body weight (not varying by \>5% for at least 90 days prior to study start). * have been treated with a stable dose regimen of met, su, tzd, met plus su, met plus tzd, or su plus tzd for at least 90 days prior to study start. exclusion criteria: * have any contraindication for the oad(s) that they use. * have a known allergy or hypersensitivity to exenatide bid, exenatide qw, or excipients contained in these agents. * have received chronic \>14 consecutive days) systemic glucocorticoid therapy by oral, intravenous (iv), or intramuscular (im) route or intra-articular steroid injection within 4 weeks prior to study start or are regularly treated with potent, inhaled steroids that are known to have a high rate of systemic absorption. * have been treated with drugs that promote weight loss (for example, glp-1 analogue, orlistat, sibutramine, phenylpropanolamine, or similar over-the-counter medications) within 90 days of study start. * have been treated for \>2 weeks with any of the following excluded medications within 90 days prior to study start: * insulin * dipeptidyl peptidase (dpp)-4 inhibitors (for example, sitagliptin or vildagliptin) * pramlintide acetate * drugs that directly affect gastrointestinal motility, including, but not limited to: reglan® (metoclopramide), propulsid® (cisapride), and chronic macrolide antibiotics. * have had prior exposure to exenatide * have previously completed or withdrawn from this study or any other study investigating exenatide bid or qw. * have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry. * are currently enrolled in any other clinical study.

Keywords: diabetes exenatide once weekly byetta amylin lilly
steam ablation versus endovenous laser ablation for the treatment of great saphenous veins

Conditions: Varicose Veins; Varicose Veins of Leg With Long Saphenous Vein Distribution

Summary: endovenous laser ablation is a common therapy of great saphenous vein insufficiency with a very high success rate. it works by heating and thereby obliterating the vein. steam ablation is a new therapy that also works by heating and thereby obliterating the vein. the hypothesis of this study is that steam ablation is as effective as laser ablation, but that it results in better secondary outcomes (e.g., lower pain scores).

the study is a randomized clinical trial comparing two different therapies for endovenous ablation of great saphenous veins. the aim of the study is to test whether the anatomical success rate of steam ablation is not inferior to that of endovenous laser ablation (evla) in treatment of great saphenous vein insufficiency and compare the treatment safety, patient reported outcomes and cost-effectiveness analyses between evla and steam ablation.

Eligibility criteria:
inclusion criteria: * patients over 18 years old * insufficiency of the gsv measured with ultrasound imaging, reflux \> 0.5 s, and diameter of vein \> 0.5 cm * symptoms of chronic venous insufficiency * no prior treatment of the insufficient gsv * informed consent exclusion criteria: * acute deep or superficial vein thrombosis * agenesis of deep vein system * vascular malformation or syndrome * post-thrombotic syndrome, occlusive type * pregnancy * immobility * allergy to lidocaine * arterial insufficiency

Keywords: endovenous laser ablation endovenous steam ablation great saphenous veins quality of life
core warming in covid-19 patients undergoing mechanical ventilation

Conditions: Covid19

Summary: the purpose of the proposed pilot study is to determine if core warming improves respiratory physiology of mechanically ventilated patients with covid-19, allowing earlier weaning from ventilation, and greater overall survival.

this is a small scale pilot study to evaluate if core warming improves respiratory physiology of mechanically ventilated patients with covid-19, allowing earlier weaning from ventilation, and greater overall survival. this prospective, randomized study will include 20 patients diagnosed with covid-19, and undergoing mechanical ventilation for the treatment of respiratory failure. patients will be randomized in a 1:1 fashion with 10 patients (group a) randomized to undergo core warming, and the other 10 patients (group b) serving as the control group who will not have the ensoetm device used. patients randomized to group a will have core warming initiated in the icu or other clinical environment in which they are being treated after enrollment and provision of informed consent from appropriate surrogate or legally authorized representative.

Eligibility criteria:
inclusion criteria: * patients above the age of 18 years old. * patients with a diagnosis of covid-19 on mechanical ventilation. * patient maximum baseline temperature (within previous 12 hours) \< 38.3°c. * patients must have a surrogate or legally authorized representative able to understand and critically review the informed consent form. exclusion criteria: * patients without surrogate or legally authorized representative able to provide informed consent. * patients with contraindication to core warming using an esophageal core warming device. * patients known to be pregnant. * patients with \<40 kg of body mass. * patients with dnr status. * patients with acute stroke, post-cardiac arrest, or multiple sclerosis.
prediction of late fetal growth restriction using cerebroplacental ratio

Conditions: Fetal Growth Retardation; Stillbirth; Neonatal Respiratory Failure; Neonatal Death

Summary: to investigate the screening performance of cpr and biophysical profile score for the prediction of composite of adverse neonatal morbidity and mortality and operative delivery (cs or instrumental) for intrapartum fetal distress in low-risk pregnancies

fetal growth is a dynamic process and its assessment requires multiple observations over time. in most women, placental function is sufficient to allow appropriate fetal growth throughout pregnancy, however in some, it may be not near term or during labor leading to intrapartum compromise small for gestational age (sga) is estimated fetal weight (efw) or abdominal circumference (ac) below the 10th percentile of given reference ranges fetal growth restriction (fgr) is fetus that has not achieved its growth potential. there are early-onset (\< 32 weeks) and late-onset (≥ 32 weeks) types. late fgr is defined as - ac/efw \< 3rd centile or at least two out of three of: 1. ac/efw \< 10th centile 2. ac/efw crossing centiles \>2 quartiles 3. cerebroplacental ratio (cpr) \ 95th centile fgr fetuses will not necessarily be sga at delivery and vice versa. in fact, most sga are likely to be 'constitutionally' small cpr is the ratio of the middle cerebral artery pulsatility index (mcapi) to (uapi). the cpr gradually rises until around the 34th week and subsequently slowly declines until term. its use has been echoed recently because of association of an abnormal ratio with fetal distress in labor requiring emergency cesarean section , a lower cord ph, admission to the intensive care unit and poor neurological outcomes the biophysical profile (bpp) abnormalities that characterize late fgr include alteration of fetal breathing, oligohydramnios and loss of fetal heart rate reactivity on conventional cardiotocography ( ctg). it seems that bpp becomes abnormal only shortly before stillbirth .

Eligibility criteria:
inclusion criteria: * •women with uncomplicated singleton pregnancy who are planning a vaginal delivery * gestational age from 36 ± 0/7 weeks until onset of active labor (cervical dilatation ≤ 4cm) * cephalic presentation exclusion criteria: * •multiple pregnancy * known sga fetus. * medical disorders with pregnancy: diabetes mellitus, hypertension, pre-eclampsia * known fetal anomaly or aneuploidy or stillbirth. * any contraindication of vaginal delivery eg. placenta previa.

Keywords: cerebroplacental ratio fetal growth restriction term pregnancy doppler ultrasound
correlation of soluble suppression of tumorigenicity 2 (st2) with golimumab (mk-8259) response in participants with ulcerative colitis (uc) (mk-8529-022).

Conditions: Colitis, Ulcerative

Summary: the purpose of this study is to evaluate serum soluble human st2 protein, the receptor for interleukin-33 (il-33) and a member of the proinflammatory interleukin-1 (il-1) receptor superfamily, as a surrogate biological marker predictive of disease outcome and therapeutic response to golimumab treatment in participants with moderate to severe uc who have failed on prior conventional therapies. the primary endpoints of this study are to correlate serum soluble st2 levels with endoscopic activity (endoscopic subscore of the mayo score) and histological activity (geboes index) of disease.


Eligibility criteria:
inclusion criteria: * inadequate response to conventional therapy including corticosteroids or are intolerant to, or have medical contraindications for conventional therapies * uc diagnosed prior to screening, based on a biopsy collected at endoscopy * moderate to severe active uc with total mayo score of 6 to 12, inclusive at baseline, and endoscopic mayo sub-score, greater than or equal to 2 * adenomatous polyps removed within last 5 years or at the screening visit prior to the first drug treatment * extensive colitis for ≥ 8 years, or disease limited to the left side of the colon for ≥10 years should have a colonoscopy to exclude the presence of dysplasia within 1 year prior to study inclusion or a colonoscopy to exclude the presence of malignancy at the screening visit * no history of untreated latent or active tuberculosis (tb) prior to screening * negative stool results for enteric pathogens exclusion criteria: * history of asthma * history of autoimmune diseases * history of hypertension
praegnant breast cancer: early/advanced/metastatic

Conditions: Advanced/Metastatic Breast Cancer; Breast Cancer (Early Breast Cancer)

Summary: among patients with breast cancer the subgroup of patients with metastases are considered the group of patients with the worst prognosis. not only regard-ing therapy decisions but also with regard to quality assured healthcare and health economics this entity of patients remains a challenge. recently, novel advances in breast cancer therapy aim at the targeted therapy of tumor entities and identification of patients, for whom the greatest therapy benefit, and the least side effects are expected. however molecular assessment of the patient and the tumor in the metastatic situation is not performed on a routine basis and in many cases tumor character-istics from the primary tumor are considered reliable enough to make therapy decisions for the metastatic patients. although molecular reassessment of tu-mor characteristics from tumor material of the metastasis is recommended in national guidelines, only a minority of patients is biopsied, because of the inva-siveness of the procedure, even though biopsy related complications are reported to be rare. with modern analytic methods from blood based biomaterial there seems to be an opportunity to correlate blood based tumor assessments with actual charac-teristics of the tumor. these include expression analysis, tumor mutation analy-sis, tumor gene copy number aberrations and others. one of the main aims of the praegnant study is therefore to establish an infrastructure for the compre-hensive analysis of tumor and metastatic molecular characteristics of the patient and the tumor. furthermore, health care related outcomes as well as health economics provide novel approaches for integration of patients in study conduct and health care awareness and are study aims of the praegnant study.


Eligibility criteria:
inclusion criteria for the early breast cancer setting: * adult breast cancer patients (age ≥18 years) * patients with breast cancer and no evidence of distant metastases with a diagnosis not longer than 91 days before study entry * patients, who are able and willing to sign the informed consent form inclusion criteria for the advanced/metastatic setting: * adult women aged ≥18 years * patients with the diagnosis of invasive breast cancer (in german: mammakarzinom, as op-posed to "non-invasive"= ductales carcinoma in situ; irrespective of status of bc, e.g. tnm, re-ceptor status etc.) and * patients, who are willing and able to sign the informed consent form * patients with metastatic or locally advanced, inoperable disease proven by clinical measures (i.e. standard imaging) exclusion criteria: * patients who did not sign the informed consent form * patients, who are not eligible for observation due to non-availability and/or severe comor-bidities as evaluated by the treating physician
assessment of oral health in minors incarcerated at fleury merogis: retrospective observational study

Conditions: DMFT Index, ICDAS Score, Dental Plaque Index, Communication, Prevention, Dentist, Orthodontist

Summary: the goal of this study is to assess the oral health of males juveniles incarcerated at fleury-mérogis over a given period. the goal is also to understand the needs of these patients and improve their care in prison while raising awareness about oral health to achieve lasting results. hypothesis: incarcerated juveniles often grew up in precarious conditions. is their dmft (decayed, missing, filled permanent teeth) index higher than the "standard" juvenile population? public interest: understanding the needs of these juvenile patients, public health data. by comparing our results to those of the "standard" population (non-incarcerated minors) through a literature review regarding the dmft index in these patients, we will determine whether incarcerated juvenile patients represent a population at risk of developing oral pathologies. oral disease prevention for these patients to raise awareness of the importance of oral hygiene and follow-up dental appointments outside of the prison system. the earlier these patients are educated, the greater the chance they will develop better habits throughout their lives.

this is a retrospective observational study in which we will collect data from the first dental consultation between june 2024 and december 2024. the primary objective is to assess the oral health of minors incarcerated at fleury-mérogis using the primary outcome measure, the dmft index. 77 male minors are included in the study. data will be collected retrospectively by the research team from their medical records. the data will be collected by the research team in a pseudo-anonymized form in an electronic crf (case report form) and then analyzed by the biostatistician at the clinical research unit of the centre hospitalier sud francilien.

Eligibility criteria:
inclusion criteria: * male minor patients incarcerated at the fleury-mérogis prison between june 2024 and december 2024 * patients who have had a dental check-up exclusion criteria: - patients and/or those with parental authority who have been informed and have objected to the use of their data.- female patients and/or those with parental authority over the newborn who have objected to the use of their data.

Keywords: dental caries dmf index oral health oral hygiene humans adolescent jails prisoners young adult male prevalence france epidemiology retrospective studies observational studies as topic
study to identify adequate biomarker to detect vitamin b12 deficiency in type 2 diabetic patients treated with metformin

Conditions: Diabetes Mellitus Type 2

Summary: in this study we compare the vitamin b12 status by measuring serum vitamin b12 and holotranscobalamin in type 2 diabetic patients with and without metformin treatment. afterwars we investigate which biomarker could be adequate to reflect b12 status in metformin-treated patients. with the help of a questionnaire we assess clinical, nutritional and demographic factors which are associated with vitamin b12 deficiency.


Eligibility criteria:
inclusion criteria: * diagnosis of t2dm \> 6 months * metformin treatment for at least 6 months * age \> 18 years * ability to give written informed consent * no metformin treatment in the last 6 months (control group) exclusion criteria: * concurrent intake of preparations containing vb12 (within the last 3 months prior to study participation) * lack of written and/or oral understanding in german, french, italian or english languages * diagnosis of transcobolamin transporter defect * diagnosis of chronic or acute liver diseaseliver insufficiency with child-pugh scores b and c and acute hepatitis * diagnosis of renal disease (creatinine-clearance \<60 ml/min)renal insufficiency stadium iii, iv and v (kdoqi) and acute renal diseases
pericapsular nerve block versus interscalene nerve block for acute pain management in shoulder arthroscopy

Conditions: Pericapsular Nerve Block; Interscalene Nerve Block; Shoulder Arthroscopy

Summary: the aim of this study is to compare peng and isb after shoulder arthroscopy for postoperative pain management after shoulder arthroscopy.

shoulder arthroscopy is a common procedure done is orthopedics for many surgical indications as rotator cuff tears, stiffness and instability. this procedure has a well - documented postoperative pain. to improve the outcome after surgery, effective pain control is needed. various methods are used for postoperative pain management. intravenous opioid agents are among them, but they may cause undesirable side effects, such as respiratory depression, sedation, constipation, allergic reaction, nausea, and vomiting. thus, alternative techniques are preferred. interscalene brachial plexus blocks (isbpbs) are often used to provide perioperative analgesia and anesthesia for shoulder surgery. they target nerve roots c4-c6 and thereby provide regional analgesia to the shoulder and upper arm. although isbpbs are often performed in combination with general anesthesia (ga) to enhance postoperative analgesia, they are also sometimes used as a sole means of anesthesia. the pericapsular nerve group (peng) block is an ultrasound-guided approach, first described by giron-arango et al. for the blockade of the articular branches of the femoral, obturator and accessory obturator nerves that provide sensory innervation to the anterior hip capsule. it has been successfully used as an alternative regional anaesthesia technique for the management of acute pain after hip fracture, and for analgesia after elective hip surgery

Eligibility criteria:
inclusion criteria: * body mass index \< 40 kg/m2 * american society of anesthesiologists (asa) physical status i-ii * posted for elective shoulder arthroscopy exclusion criteria: * known allergy to local anesthetics * allergy to all opioid medications * diagnostic shoulder arthroscopic procedures * patients with chronic opioids use and coagulopathy
health promotion in adolescents in ecuador

Conditions: Overweight

Summary: worldwide, low-income and middle-income countries are undergoing rapid demographic and nutritional changes. populations tend to move from their traditional food habits towards dietary patterns characterized by a more energy-dense diet, while urbanization and technology (work, transport) play a role in the reduction of their physical activity. this shift towards energy-dense diets and lower levels of physical activity are key determinants of chronic diseases. nowadays, childhood overweight and obesity are becoming a major threat to public health all in low-income and middle-income countries. clearly, not properly addressing this health problem will only aggravate the already enormous impact of chronic diseases on the social and economic development of these countries. this study aims to develop a culturally relevant school-based prevention intervention among ecuadorian adolescents (11-13 years old) in cuenca. the intervention will target behavioural nutrition and physical activity. intervention strategies will be developed based on theoretical behavioural change models integrated in two complementary frameworks, i.e. (i) the intervention mapping protocol, and (ii) the comprehensive participatory planning and evaluation protocol. the study includes two phases: 1. a formative research, which will be conducted in order to understand the causality of the school environment and unhealthy eating and low physical activity levels in school-going adolescents, aged 12-13 years old. 2. a paired, cluster-randomized controlled trial including 1400 adolescents (12-13 years old) from 10 pairs of schools (i.e. clusters). within each pair of clusters, one cluster will be randomly assigned to the intervention and the other to the control group.


Eligibility criteria:
inclusion criteria: * 11-13 years old * school-going * willing to participate exclusion criteria: * pregnant * severe medical/physical disorder

Keywords: promoting healthy lifestyles in adolescents in ecuador to prevent overweight
labor induction in preeclampsia high-risk women

Conditions: Pre-Eclampsia; Induction of Labor

Summary: preeclampsia (pe) is one of the leading causes of maternal and perinatal morbidity and mortality. this pregnancy-specific disorder poses to both pregnant women and their offspring an increased risk of immediate and long-term health problems. the study team is conducting a study entitled "forecast" (implementation of first-trimester screening and prevention of preeclampsia trial) and established the infrastructure for the first-trimester "screen and prevent" program for preterm pe. however, there is no established evidence regarding the benefit of scheduled labor induction versus expectant management among women identified as high-risk for pe with uncomplicated pregnancy at term. the investigators postulate that induction of labor at 39 weeks' gestation may possibly be an effective intervention to reduce placental complications in women with uncomplicated pregnancy by 39 weeks at high-risk pe women.


Eligibility criteria:
inclusion criteria: * age no less than 18 years * singleton pregnancy with cephalic presentation and no contraindication to vaginal delivery * live fetus * screened high-risk for pe * informed and written consent exclusion criteria: * multiple pregnancy * pregnant women who plan to have cesarean delivery * pregnancies complicated by the major fetal abnormality * women who are severely ill, those with learning difficulties, or serious mental illness * pregnant women with medical, obstetric, or fetal complications or any other indications for delivery before 39 weeks' gestation

Keywords: aspirin biomarker blood pressure hypertension mean arterial pressure placental growth factor pre-eclampsia prediction uterine artery pulsatility index induction of labor
observational study of incidence of breakthrough cancer pain and how it is treated

Conditions: Advanced Cancer

Summary: the purpose of this study is to describe how often advanced cancer patients experience breakthrough pain (btcp), and to describe how this pain is treated, and how effective these treatments are.


Eligibility criteria:
inclusion criteria: * diagnosis of neoplasm in advanced stage * chronic pain controlled for at least one week with opioids 60 mg / day morphine equivalent * 1-6 episodes of btcp within any of 3 days previous to registration into study * signed informed consent exclusion criteria: · more than 6 episodes of btcp within any of 3 days previous to registration into study

Keywords: breakthrough cancer pain pain neuropathic pain intractable pain cancer