Kornimate/medical-research-clean huggingface dataset:
a phase iii study of bms-512148 (dapagliflozin) in asian patients with type 2 diabetes who are not well controlled with diet and exercise

Conditions: Type 2 Diabetes

Summary: the purpose of this clinical research study is to learn if bms-512148 (dapagliflozin) can improve (decrease) blood glucose values in asian patients with type 2 diabetes who have never been treated with medication or have been on medication for less than 24 weeks since their original diagnosis of diabetes. the safety of this treatment will also be studied.


Eligibility criteria:
inclusion criteria: * males and females, 18 years old, with type 2 diabetes and with inadequate glycemic control * drug naive or treated with anti-diabetic medication for \< 24 weeks * c-peptide ≥ 1.0 ng/ml * body mass index ≤ 45.0 kg/m² exclusion criteria: * ast and/or alt \> 3 times uln * serum total bilirubin \> 2 mg/dl * serum creatinine ≥ 1.50 mg/dl for men or ≥ 1.40 mg/dl for women * creatine kinase ≥ 3 times uln * symptoms of severely uncontrolled diabetes * currently unstable or serious cardiovascular, renal, hepatic, hematological, oncological, endocrine, psychiatric, or rheumatic diseases
achieving portal access with scorpion post-approval study (apass)

Conditions: Portal Hypertension; Liver Diseases; Ascites Hepatic; Hydrothorax; Vascular Diseases

Summary: creation of the parenchymal tract between the portal vein and the hepatic vein is the most difficult and time consuming step in a tips procedure. the purpose of this study is to evaluate portal vein access sets during the tips procedure.


Eligibility criteria:
inclusion criteria: 1. ≥ 18 years of age at the time of the tips procedure 2. tips procedure initiated for refractory variceal bleeding, refractory ascites and/or hydrothorax 3. willing and able to provide written informed consent and hipaa (health insurance portability and accountability act) authorization 4. willing and able to comply with the study procedures and follow up schedule exclusion criteria: 1. known active malignancy 2. meld score ≥ 18 at time of screening 3. history of polycystic liver disease 4. active bleeding from any source 5. pulmonary hypertension, heart failure, severe tricuspid valve dysfunction, right to left cardiopulmonary shunt 6. chronic, occlusive portal vein thrombosis or complete portal vein thrombosis of the main or target portal vein on prior ct examination 7. active or uncontrolled hepatic encephalopathy 8. systemic infection/sepsis 9. biliary obstruction 10. uncorrectable coagulopathy 11. any diminutive or partially thrombosed right portal vein 12. hepatic vein thrombosis (i.e., no budd-chiari syndrome) 13. known sensitivity to contrast or serious contrast reaction such as anaphylaxis 14. pregnant women or women who are planning to become pregnant

Keywords: transjugular intrahepatic portosystemic shunt tips portal vein access
functional and clinical benefits of pci in patients with cto

Conditions: Heart Function; Quality of Life

Summary: the purpose of this study is to compare the diagnostic accuracy of hybrid imaging combining ctca with low-dose stress-only spect vs. coronary angiography for detecting haemodynamic relevant coronary lesions; and second to determine the effects of pci on cardiac perfusion, cardiac function and quality of life in patients with cto lesion in left anterior descending (lad) coronary artery.

noninvasive imaging modalities have shown high diagnostic accuracy in the detection of coronary artery lesions, and for the estimation of their hemodynamic relevance.thus, noninvasive assessment of myocardial perfusion defects may be preferred for patients with chronic total occlusion (cto). in particular, myocardial perfusion is measured with single photon emission ct (spect).multislice coronary ct angiography (ccta) with dual-source scanners reveals the anatomic location of coronary artery disease (cad). these two techniques assess distinct aspects of heart morphology and function parameters of the heart, and should therefore be regarded as complementary rather than competing methods.taking this into consideration, decisions regarding whether invasive revascularization therapy is adequate or not and which strategy is the best for long-term survival cannot be supported by anatomic information alone. therefore, noninvasive complementary imaging of structure and perfusion, in conjunction with three-dimensional (3d) image fusion, has emerged as a technique for reliable allocation of perfusion defects to their supplying coronary artery.

Eligibility criteria:
inclusion criteria: * patients were eligible for enrolment in this study if coronary angiography showed a cto (at least for 3 months and confirmed by angiography and/or history of earlier mi). exclusion criteria: * hypersensitivity to iodinated contrast agent, cardiomyopathy, non-sinus rhythm, severe valvular heart disease, nyha functional class iv heart failure at baseline, previous coronary bypass surgery, renal insufficiency, severe lung and liver disease or cancer.

Keywords: percutaneous coronary intervention chronic total occlusion coronary angiography single photon emission ct multislice coronary ct angiography
online mindfulness-based intervention to decrease pre-procedural anxiety before a first-time screening colonoscopy

Conditions: Colorectal Carcinoma

Summary: this clinical trial tests how well an online mindfulness-based intervention (mbi) works to decrease anxiety in patients before a first-time screening colonoscopy. elevated pre-procedural anxiety can affect patient outcomes including bowel preparation adherence and quality, the amount of sedation required, procedure time, patient satisfaction, cancellation or no-shows, and intention for future cancer screening. mindfulness is a form of meditation that focuses on staying within the present moment to reduce anxiety. previous research supports mindfulness practice among cancer survivors to decrease anxiety, fear of cancer re-occurrence, and to improve quality of life. online mbis have the potential to include targeted meditations and educational information designed to promote behavior change. this study may help researchers learn whether a mindfulness intervention works to decrease anxiety in patients before a first-time screening colonoscopy.

primary objective: i. to establish intervention feasibility and acceptability, and to collect preliminary efficacy data on a developed online mindfulness-based intervention (mbi) to reduce pre-procedural anxiety before a first-time screening colonoscopy compared to usual care. outline: patients are randomized to 1 of 2 groups. group i: patients receive usual care prior to their scheduled screening colonoscopy. group ii: patients receive an online mindfulness intervention including infographics and 5-minute meditations once daily (qd) for 5 days prior to their scheduled screening colonoscopy. after completion of study intervention, patients are followed up 1-2 days post-colonoscopy.

Eligibility criteria:
inclusion criteria: * patients must be ages 45-75 * patients must be at average risk for colorectal cancer (crc) * patients must have scheduled their first-time screening colonoscopy as an outpatient at ohio state university (osu) at least 14 days in advance * patients must be able to speak and read english * patients must have daily access to a working telephone, email address, and internet connection * patients must provide consent exclusion criteria: * previous colonoscopy * colonoscopy for diagnostic purposes * auditory or visual impairment that prevents internet use * previous cancer diagnosis (other than skin cancer) * previous diagnosis of a mental health disorder * current mental health treatment * family history of crc * personal history of inflammatory bowel disease (ulcerative colitis or crohn's disease) * confirmed or suspected hereditary crc syndrome, such as familial adenomatous polyposis or lynch syndrome
fit child - clinical study on weight control

Conditions: Overweight; Nutrition Disorder, Child; Weight Change, Body

Summary: children with abnormal weight development of bmi will be given either placebo or a probiotic protein formula and measures of weigh gain during a 3-mont treatment will be conducted

in this study, children with abnormal weight development of bmi will be recruited and the gut microbiota will be modified using one of there treatment schedules. the subjects will be divided into three groups 1) receiving a daily drink with protein drink with a probiotic lactobacillus rhamnosus gg or 2) placebo drink and/or 3) drink with lactobacillus rhamnosus gg. the children will give a faecal sample in the beginning and at the end and similarly also a blood sample. the faecal sample will be used for analysis of microbiota and differences in microbiota between the groups. blood samples will be analysed for obesity related biomarkers. body weight is followed at home and at frequent intervals of the study and analyses made for overweight related biomarkers.

Eligibility criteria:
inclusion criteria: 2-5 year old child with early weight gain and abnormal bmi, parental concern on weight gain/development - exclusion criteria:medicines influencing gastric or intestinal function, antibiotic treatment during the last 6 months, use of specific probiotics

Keywords: overweight probiotic weight management
assessment of fatty liver with thermo-acoustic device

Conditions: NASH; NAFLD; Non-alcoholic Fatty Liver; Non-Alcoholic Fatty Liver Disease; Non-alcoholic Steatohepatitis; Fatty Liver; Fatty Liver Disease

Summary: the study will evaluate the accuracy of hepatic steatosis estimation by thermo-acoustic ultrasound with estimation by mri-pdff (proton density fat fraction) . it will also evaluate the sensitivity of this device in the diagnosis of fatty liver.

patients with either known or presumed diagnosis of non-alcoholic fatty liver disease who meets eligibility criteria will be included in the study. they will have imaging done to estimate hepatic steatosis by two modalities (mri - pdff and thermo-acoustic ultrasound). the estimation obtained by thermo-acoustic ultrasound will be compared with mri results for accuracy of estimation by the thermo-acoustic ultrasound device. the study will also evaluate the sensitivity of the thermo-acoustic ultrasound device if it can diagnose the presence of hepatic steatosis when hepatic fat content is 15% or less by volume.

Eligibility criteria:
inclusion criteria: * patients diagnosed or suspected to have non-alcoholic fatty liver disease * patients 18-70 years of age * be able to understand and sign on written informed consent * able to undergo ultrasound and mri examinations exclusion criteria: * any metal or electronic implants including but not limited to pacemakers, clips, hips * known history of pregnancy or becoming pregnant during study period * unable to understand and sign on written informed consent * intolerant to ultrasound and/or mri examinations
evaluation of a computer-based, self-management tool for people with type 2 diabetes

Conditions: Diabetes Mellitus, Type 2

Summary: new brief summary: managing diet and physical activity are vital aspects of diabetes self-care; however, people with diabetes often find it difficult to make changes to their usual diet and physical activity patterns. there is some evidence that computer based education may help some people develop the skills they need to better manage their diabetes. the investigators have developed an external hard drive (a usb stick), focusing on knowledge, self-monitoring, goal setting and skill-development in relation to diet and physical activity for people with type 2 diabetes. a major emphasis was placed on eliciting the views of people with type 2 diabetes throughout the development of the computer based program. this study will examine whether this computer based program can improve knowledge, skills and self-care behaviour in people with diabetes. one hundred participants who have been diagnosed with type 2 diabetes in the past 2 years will be assigned by chance to one of two groups: they will either be assigned to continue with their normal care routine consulting with their doctor as normal, or they will be assigned to use the usb stick at least once a week for 12 weeks.


Eligibility criteria:
inclusion criteria: * medical diagnosis of type 2 diabetes in the past 2 years * have access to a computer on a regular basis exclusion criteria: * pregnant or lactating * other medical conditions where changes in diet or physical activity would be contraindicated

Keywords: diet physical activity self management goal setting
study to investigate the effects of orteronel on the qt/qtc interval in patients with metastatic castration-resistant prostate cancer

Conditions: Prostate Cancer

Summary: the purpose of this phase 2, open-label, single-arm, multidose, multicenter study is to investigate the effects of orteronel plus prednisone on the qt/qtc interval in patients with metastatic castration-resistant prostrate cancer


Eligibility criteria:
inclusion criteria: * voluntary written consent * screening psa ≥ 2ng/ml * patients must have a diagnosis of mcrpc * eastern cooperative oncology group (ecog) performance status 0 to 1 * prior surgical or medical castration with testosterone at screening \< 50 ng/dl exclusion criteria: * prior chemotherapy for prostate cancer within 6 months prior to screening. (any prior therapy with cabazitaxel, mitoxantrone, or anthracyclines is exclusionary.) * documented central nervous system metastases * clinically significant heart disease * patients who have an abnormal 12-lead ecg result at screening including one or more of the following: qrs\>110 ms, qtcf\>480ms, pr interval\>200 ms * patients who have a history of risk factors for tdp including unexplained syncope, known long qt syndrome, heart failure, angina, or clinically significant abnormal laboratory assessments please note that there are additional inclusion and exclusion criteria. the study center will determine if you meet all of the criteria. site personnel will explain the trial in detail and answer any question you may have if you do qualify for the study. you can then decide whether or not you wish to participate. if you do not qualify for the trial, site personnel will explain the reasons

Keywords: metastatic castrate resistant prostate cancer, mcrpc, orteronel, tak-700, phase 2, qt, qtc
continuous transversus abdominis plane nerve block for postoperative analgesia

Conditions: Incisional Pain

Summary: research study to determine if putting local anesthetic through one or two tiny tubes next to the nerves that go to the area the patients are having surgery on (abdomen or pelvis), will improve pain control following surgery. this study will also help determine if patients require fewer pain pills, experience fewer sleep disturbances, and are more satisfied with their postoperative pain control.

specific aim: to determine if adding a continuous transversus abdominis plane nerve block to a single-injection nerve block results in improved postoperative pain control. hypothesis 1: adding a continuous transversus abdominis plane nerve block to a single-injection nerve block results in lower average pain scores during movement the day following surgery. specific aim2: to determine if adding a continuous transversus abdominis plane nerve block to a single-injection nerve block results in decreased average pain scores, opioid use, sleep disturbances, and improved patient satisfaction. hypothesis 2: adding a continuous transversus abdominis plane nerve block to a single-injection nerve block results in decreased average pain scores, oral opioid consumption, sleep disturbances, and improved patient satisfaction the day following surgery.

Eligibility criteria:
inclusion criteria: * undergoing ambulatory inguinal and/or abdominal surgery amenable to a transversus abdominis plane nerve block (unilateral or bilateral). * expected postoperative pain to be at least moderate in severity the day following surgery * age 18 years or older * desires a regional anesthetic for postoperative analgesia * is able to understand the possible perineural infusion-related complications, study protocol, and catheter/pump care * has a caretaker through the first night after surgery * has an asa physical status classification of 1-3 exclusion criteria: * any contraindication for a continuous transversus abdominis plane nerve block * any physical, mental or medical conditions which, in the opinion of the investigators, may confound quantifying postoperative pain resulting from surgery. * current chronic opioid or tramadol use * history of alcohol or opioid abuse * know allergy or other contraindication to the study medication * pregnancy * known hepatic or renal insufficiency/disease * peripheral neuropathy of the surgical site * morbid obesity * inability to communicate with the investigators and hospital staff * incarceration

Keywords: pain ucsd catheter nerve block hernia post-surgery pain abdominal pain pelvic pain transversus abdominal plane hernia repair transversus abdominal plane block
sport mouthguards: devices for preventing dental injuries in sports

Conditions: Oral Health; Dental Trauma; Oral Health Knowledge, Attitude and Practice Among Patients; Mouth Protectors

Summary: objective: to evaluate the impact of mouthguards (mg) on acceptability, incidence of soft tissue injuries, periodontal and salivary parameters, as well as on the perception of the body in sports practice (pecopes) and on the quality of life of athletes, and evaluate the consequences of use on the characteristics, state of conservation, and biological and physical properties of the mg itself. methodology: this is a longitudinal study that will include children, adolescents, and adults aged 7 to 30 years who practice sports and require mgs. sociodemographic data, medical history, dental history, dietary habits, and sports practice data will be collected. participants will undergo a complete oral clinical examination. data on knowledge of traumatic dental injuries (tdi) and mgs will also be collected. before the mg is delivered, immediately after installation, and at 1, 3, and 6 months after use, the following parameters will be evaluated: presence of mucosal injuries, visible plaque index, gingival bleeding index, salivary flow, salivary ph, buffering capacity, and salivary microorganism count. acceptability will be evaluated before the mg is delivered, immediately after delivery, and at 1, 3, and 6 months after use. pecopes and quality of life will be assessed before, 1, 3, and 6 months after mg use. the mg will be evaluated for bacterial contamination, delamination, roughness, dimensional changes related to shape and thickness, color change, and conservation status. the data will be tabulated and analyzed using spss 21.0, and appropriate statistical tests (p\<0.05) will be performed according to the study objectives.


Eligibility criteria:
inclusion criteria: * children, adolescents, and adults aged 7 to 30 years, with no systemic health issues, of both genders; * engaging in sports practice at least twice a week. exclusion criteria: * presence of cavitated dental caries and/or periodontitis; * angle class iii malocclusion with negative anterior overjet; * presence of non-removable prostheses or any other accessory in the upper or lower arch that may interfere with the adaptation of the mouthguard; * use of medications that may interfere with any salivary parameters; * children, adolescents, and adults with neurological disorders or communication difficulties.

Keywords: mouth protectors athletes sports dental trauma questionnaire oral health
arm and finger measurement for blood pressure surveillance

Conditions: Hypertension, Pregnancy-Induced

Summary: accurate blood pressure (bp) measurement is critical in peripartum care. the cuff and bladder sizes affects the accuracy of bp measurement. current international bp measurement recommendations are based on mid-arm circumference (mac). however, evidence have shown the discrepancies between these sizes, leading to inaccuracy of bp measurement. this study will measure arm and finger size of 300 parturients in third trimester to determine whether the mac, finger measurement or body mass index (bmi) is the best clinical predictor for non-standard cuff sizes for bp measurement.

accurate blood pressure (bp) measurement plays an important role in peripartum care as it is essential in detecting hypertensive disorders in pregnancy and medical decision making during the pregnancy. the cuff and bladder size have been highlighted as an important factor affecting the accuracy of bp measurement. current international bp measurement recommendations are based on mid-arm circumference (mac) assuming the arm is cylindrical in shape. however, evidence have shown a mismatch between these sizes, leading to bp overestimation or underestimation in obese patients. this is because the shape of the arm is a truncated cone instead of a cylinder, and the cuff will expand irregularly during inflation thus yielding inaccurate bp measurements. this is especially evident in asian pregnant patients whereby no available guideline can recommend a suitable cuff for parturients with different mac. nexfin is a finger cuff device that can be a suitable alternative bp measurement device for such patients. in this study 300 parturients will be recruited in third trimester and undergoing nonemergent caesarean section in kkh. patients' arm and finger sizes will be measured, and their user experience on current practices on bp measurement. the arm measurements will help to identify the proportion of women that may require non-standard cuff sizes for bp measurement. a conicity index will be determined whether the mac, finger measurement or bmi is the best clinical predictor. the finger measurements will also help to determine the proportion of women that may require non-standard cuff sizes on the nexfin device for bp measurement. the knowledge gathered in this pilot study will be used to design future studies in which the accuracy of nexfin will be compared with standard bp measurement, which in turn will improve bp detection, subsequent patient monitoring and satisfaction.

Eligibility criteria:
inclusion criteria: * american society of anaesthesiologists physical status 1 or 2 (asa 1 or 2) parturients at 32 or more weeks of gestation * multiparous or nulliparous; * age 21-50 years old; * undergoing caesarean section in our institution. exclusion criteria: * emergent caesarean section such that consent and measurements cannot be taken.

Keywords: blood pressure measurement conicity index mid arm circumference cuff size