Kornimate/medical-research-clean huggingface dataset:
observational study describing conditions for administering slow-acting insulin analogue with oral antidiabetic agents in type 2 diabetes on blood glucose control

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this study is conducted in europe. the aim of this observational study is to describe the conditions for the concomitant administration of a slow-acting insulin analogue with oral antidiabetics (oads) in order to improve blood glucose control in type 2 diabetes.


Eligibility criteria:
inclusion criteria: * type 2 diabetes * hba1c level greater than 7% despite treatment with two (or three) oral antidiabetic drugs (oads) at an optimal dose level * patient agreeing to take part in the study and capable of completing a self-questionnaire. exclusion criteria: * hypersensitivity to insulin or to one of the excipients * treatment with insulin for at least 6 months * participant in a clinical trial for diabetes on entry into the observational study
sirolimus prophylaxis for agvhd in tme scid

Conditions: Severe Combined Immunodeficiency; Transplacental Maternal Engraftment; Stem Cell Transplant

Summary: study design: scid infants receiving an unconditioned haploidentical transplant will be started on sirolimus (0.05 mg/kg/day) day -5 for acute graft-versus-host disease (agvhd) prophylaxis. sirolimus levels will be monitored with goal sirolimus trough level of 5-8 ng/ml. patients will be monitored for signs of agvhd as defined by ucsf sop cl 221.06 through day +100. sirolimus will be tapered once t-regulatory cell to cd4 effector cell ratio is \> or = 9%. setting: inpatient bmt unit benioff children's hospital at ucsf medical center study subjects: 15 infants with diagnosis of maternally engrafted t cells scid by ca newborn screen receiving unconditioned haploidentical hsct main outcome measures: incidence of agvhd (dermatitis, hepatitis, enteritis) as defined by sop cl 221.06 by day +100. hypothesis 1. patients placed on sirolimus prophylaxis will have lower incidence of agvhd compared to historical controls. hypothesis 2. lower doses of sirolimus milligram per kilogram will be required to maintain goal troughs of 5-8 ng/ml.


Eligibility criteria:
inclusion criteria: * infants diagnosed with scid on ca newborn screen * evidence of maternal engraftment * unconditioned haploidentical hematopoeitic stem cell transplant exclusion criteria: * evidence of acute graft vs. host disease

Keywords: scid severe combined immunodeficiency maternal engraftment agvhd prophylaxis sirolimus
effect of short-term oxygen during cpet in hfpef

Conditions: Heart Failure, Diastolic (HFpEF)

Summary: in a randomized, sham-controlled crossover trial the investigators will test whether supplemental oxygen given during cardiopulmonary exercise testing will improve exercise performance and physiological parameters in patients with heart failure with preserved ejection fraction.


Eligibility criteria:
inclusion criteria: * hfpef, stable medication for at least 4 weeks. exclusion criteria: * instable status, pregnancy, clinically relevant concomitant diseases, inability to follow the study procedures
a trial of an online problem-solving intervention for aggression

Conditions: Aggression

Summary: aggressive behaviour among adolescents is a social problem that can be reduced by social problem-solving interventions. however, these interventions usually include more than one technique, and the specific techniques that are effective in reducing and preventing aggression remain to be identified. therefore, the main aim of this study is to test whether the instruction and practice of problem-solving on their own are effective in changing aggressive behaviour among adolescents. as the intervention in this trial is aimed at the general population, it will be delivered online. the rapid growth in the use of the internet among young people provides an opportunity to deliver interventions universally in a cheap and efficient way. problem-solving skills are fundamental to effective behaviour change. therefore, problem-solving skills will be measured to assess whether they mediate the effect of the intervention on aggressive behaviour. finally, young people with callous-unemotional traits are less likely to change their problematic behaviour such as aggression after an intervention. therefore, callous-unemotional traits will be measured to assess if they act as a moderator of effectiveness. it is expected that participants randomised to the intervention improve their problem-solving skills and consequentially, reduce their aggressive behaviours. in addition, participants with lower callous-unemotional traits are expected to have a greater change.


Eligibility criteria:
inclusion criteria: * living in the uk * fluent in english

Keywords: problem-solving youth brief intervention online intervention young people aggressive behaviour
pgd2 formation in vascular injury

Conditions: Coronary Artery Disease; Acute Coronary Syndrome; Stable Angina

Summary: to investigate the biosynthesis of pgd2 during percutaneous transluminal coronary angioplasty (ptca) procedure.

a) to determine whether biosynthesis of pgd2 is altered in response to vascular injury in humans b) patients will be grouped base on their aspirin using status. three groups of no aspirin but an alternative anti-platelet medicine, low dose (81 mg) aspirin, high dose 325 mg aspirin will be enrolled.

Eligibility criteria:
inclusion criteria: * patients with existing cad admitted for elective ptca: 1. treated with any dose of aspirin daily for at least 5 days, with special interest in those treated with 81 mg aspirin daily or 2. treated with an alternative antiplatelet therapy, such as clopidogrel, due to aspirin hypersensitivity or pmds preference or 3. no aspirin therapy at all * patients presenting to the er with acute coronary syndrome(acs)who will have a ptca * patients with stable angina or positive stress tests scheduled for a cardiac catheterization exclusion criteria: * history of unstable diabetes (hgb a1c\>8 or fbs\> 200) * uncontrolled hypertension (sbp \> 180, dbp \>100) * history of an acute confounding disease as judged on clinical screen that according to the investigator may interfere with interpretation of the study results, or compromise the safety of a potential subject. * patients who have taken nsaids or cox-2 inhibitors other than aspirin, for at least 10 days prior to ptca

Keywords: prostaglandins vascular injury
efficacy and safety of topical essential oil extracted from zingiber cassumunar rokb in osteoarthritis

Conditions: Osteoarthritis

Summary: the objectives of this study are to assess short term efficacy and safety of of topical preparation of essential oil extracted from zingiber cassumunar roxb in patients suffering from osteoarthritic pain


Eligibility criteria:
inclusion criteria: * diagnosis: osteoarthritis of the knee at least on side with standard radiologic method within 6 weeks (kellgren-lawrence radiographic grading scale at least 1) * pain visual analog scale at rest at least 40 mm * no previous analgesic treatment or receiving stable dose of analgesic drugs at least 2 weeks. if previously treated with antidepressants, glucosamine, chondroitin or diacerein, dosage should be stable for at least 3 months. * agree to attain non-pharmacologic treatment as prior to participate the study exclusion criteria: * having an open wound or abnormal skin at site of application * having diagnose with other chronic arthritis such as rheumatoid arthritis * history of allergy to the extraction of zingiber cassumunar roxb * pregnancy or breastfeeding

Keywords: osteoarthritis moderate ot severe pain zingiber cassumunar roxb
first trimester risk assessment based on ultrasound and cell-free dna vs combined screening

Conditions: Aneuploidy

Summary: there is an ongoing debate regarding how cell-free dna (cfdna) screening can best be incorporated into current prenatal screening algorithms for chromosomal abnormalities. test performance of cfdna has been shown to be better that first-trimester combined screening (ftcs). however, the cost of the cfdna testing is considered too high to adopt as first line screening. moreover, ftcs includes a detailed ultrasound examination of the fetus with nuchal translucency (nt) measurement that allows for early detection of fetal abnormalities. an approach in which every woman are offered an early anatomy scan along with cfdna may also be a reasonable option. recently a randomized controlled trial, including 1,518 women with singleton pregnancy undergoing first-trimester screening, compared the screening performance of ftcs with an approach that uses the combination of a detailed ultrasound examination and cfdna analysis. the trial showed that first-trimester risk assessment for trisomy 21 that includes a detailed ultrasound examination along cfdna was associated with a significant reduction in the false-positive rate compared with ftcs. this approach obviates the need for maternal serum free beta-human chorionic gonadotropin and pregnancy-associated plasma protein-a in screening for fetal aneuploidy. despite robust evidence on the very high detection rate of cfdna in detecting trisomy 21, literature is lacking on data regarding women's experience and emotional well-being and satisfaction after test-results of women offered cfdna compared to those offered ftcs.


Eligibility criteria:
inclusion criteria: * pregnant women with singleton gestations * ≤12 6/7 weeks of gestation * normal ultrasound examination at the time of randomization * \>18 \<45 years * crown-rump length (crl) \<84 mm at the time of randomization exclusion criteria: * multiple gestations, including vanishing twins * \>12 6/7 weeks of gestation * ectopic pregnancy * abnormal ultrasound examination at the time of first prenatal visit * women who are unconscious, severly ill, mentally handicapped, or under the age of 18 years. * women who have already planned for invasive prenatal testing, e.g. for a history of prior child or pregnancy with chromosomal or genetic abnormalities * crl \>84mm at the time of randomization
diabetes remote intervention to improve use of evidence-based medications

Conditions: Cardiovascular Diseases; Diabetes

Summary: a randomized remote, implementation trial in the mass general brigham network was performed on 200 patients with t2d at high cv or kidney risk. the study's primary objective was to create a remote diabetes management platform that improved the initiation and adherence to glucose-lowering medications with cv and kidney benefit and was evaluated by the primary outcome: increasing the proportion of patients with prescriptions for gdmt therapy by 6 months.

a randomized remote, implementation trial in the mass general brigham network performed on 200 patients with t2d at high cv or kidney risk. patients eligible for, but not prescribed, sglt2i or glp-1 ra were randomly assigned to 1) simultaneous patient education and medication initiation "simultaneous" arm or 2) 2-months of education followed by medication initiation "education-first" arm. a multi-disciplinary team provided education and prescribed gdmt using a treatment algorithm. the study's primary objective was to create a remote diabetes management platform that improved the initiation and adherence to glucose-lowering medications with cv and kidney benefit and was evaluated by the primary outcome: increasing the proportion of patients with prescriptions for gdmt therapy by 6 months. secondary objectives included the primary outcome by randomization arm, prescribed therapy by 2 months, and patients taking prescribed therapy.

Eligibility criteria:
inclusion criteria: 1. aged 27 - 79 years at the time of agreeing to participate in the program 2. presence of type 2 diabetes (treated with metformin unless intolerant, may also be treated with dpp4i, sulfonylurea, pioglitazone, and/or basal insulin) 3. hba1c 6.5-8.9%; and 4. at elevated cardiovascular and/or renal risk defined as any diagnosed ascvd, estimated ascvd risk \>10%, congestive heart failure, non-alcoholic fatty liver disease, estimated glomerular filtration rate (egfr) \<60 ml/min/1.73m2, albuminuria above 300mg/g; and those aged 60 years or older with at least two of: active tobacco use, dyslipidemia (ldl-c above 160 mg/dl or 4.1 mmol/l, non-hdl-c above 190 mg/dl or 4.9 mmol/l, triglycerides above 175 mg/dl,) hypertension (2 systolic blood pressure values above 130 mmhg and/or 2 diastolic blood pressure values above 90 mmhg within 12 months,) or bmi above 30 5. has seen a primary care provider within the mass general brigham network within the last year exclusion criteria: 1. type 1 diabetes 2. currently or previously prescribed an sglt2i or glp1-ra 3. taking any short-acting insulin 4. history of diabetic ketoacidosis 5. history of hypoglycemia requiring hospitalization 6. frequent (more than two times in 1 week) episodes of symptomatic hypoglycemia with blood glucose \<70 mg/dl 7. egfr below 15 ml/min/m2 8. mental incapacity, unwillingness, or language barriers precluding adequate understanding or cooperation, or 9. life expectancy less than 1 year or utilizing palliative care

Keywords: digital health remote care delivery team-based care model
mild hypothermia after endovascular treatment in acute ischemic stroke

Conditions: Ischemic Stroke; Thrombolytic Therapy

Summary: to study safety and feasibility of mild therapeutic hypothermia after successful recanalization by mechanical endovascular treatment in patients with acute ischemic stroke and proximal arterial occlusion.

the current clinical trial is an investigator-initiated one, and it is conducted under the multi-center, randomized, open-label, prospective design. the subjects meeting inclusion/exclusion criteria will be assigned to the treatment group or the control group. the randomization ratio is 1:1. the subjects of the treatment group will receive a 2-day hypothermia therapy followed by the process of recovery of temperature within 30 hours (the recovery phase). after 3 months of the onset of symptoms, mrs scores are measured. this is followed by the closure of the clinical trial.

Eligibility criteria:
inclusion criteria: 1. subjects who submitted a written informed consent prior to the participation in the current clinical trial (if the subjects have conditions that they cannot decide on study participation according to their own will, they would participate in the study after their legal representatives submitted a written informed consent form. during the period of study participation, if patients' medical conditions are improved, the written informed consent should be submitted again.) 2. patients with ischemic stroke attributed to carotid artery or middle cerebral artery occlusion achieved successful recanalization (tici 2b or 3) immediately after endovascular treatment within 8 hours of symptom onset: onset time was defined as the time when patients were lastly seen normal. 3. patients of both sexes aged between 18 and 80 years old 4. nihss scores of 6-25 points at screening 5. mrs 1 prior to the onset of disease, with proximal cerebral artery occlusion (e.g., those with middle cerebral or internal carotid artery) exclusion criteria: 1. no evaluation for cranial artery before endovascular treatment 2. patient with emergent stenting insertion in intracranial or extracranial artery 3. transient ischemic attack or lacunar infarction 4. platelet counts \< 75,000/mm3 5. coagulopathy (inr spontaneously \>1.5) 6. hemodynamic instability 7. acute myocardial infarction, acute unstable angina or severe cardiac failure (nyha classification ≥iii) 8. sepsis 9. pregnant or breastfeeding women 10. premorbid modified rankin scale scores of \> 2 points 11. hypersensitivity or allergy to following: buspirone, dexmedetomidine, meperidine 12. intracranial hemorrhage or hemorrhagic transformation in initial ct scan 13. brain tumor or cns infection 14. patients who participated in other clinical trials within 3 months 15. life expectancy within 1 year

Keywords: therapeutic hypothermia
postoperative pain control in total shoulder arthroplasty

Conditions: Total Shoulder Arthroplasty

Summary: a double blind, prospective, randomized trial to evaluate postoperative pain, narcotic use, patient satisfaction, and function among shoulder arthroplasty patients receiving interscalene block with and without the addition of liposomal bupivacaine.

in order to reduce narcotic abuse potential, orthopaedic surgeons have explored multimodal pain regimens in addition to regional anesthesia to improve postoperative pain control. one commonly used intervention to reduce postoperative shoulder pain has been the interscalene brachial plexus block. this block provides significant pain relief for shoulder procedures, but has been limited to less than 24 hours even with long acting anesthetics. in the setting of shoulder arthroplasty, this short-term pain control often leads to the need for increased narcotic pain medication. since shoulder arthroplasty has been steadily increasing in the united states with an annual growth rate of 10.6%, it is imperative to control patients' postoperative pain without increasing their risk for opiate abuse. a potential method for achieving this is by using liposomal bupivacaine in the interscalene blocks. this study is a double blind, prospective, randomized trial to evaluate the postoperative pain profiles among shoulder arthroplasty patients receiving interscalene block with and without the addition of liposomal bupivacaine. the purpose of this study is to determine if patients undergoing shoulder arthroplasty with an interscalene brachial plexus block with liposomal bupivacaine (study group) or without liposomal bupivacaine (control group) will have differences in postoperative opiate consumption, patient-reported pain, satisfaction with surgery, and shoulder function.

Eligibility criteria:
inclusion criteria: • patients undergoing primary shoulder arthroplasty or reverse shoulder arthroplasty exclusion criteria: * patients under the age of 50 years * patients over the age of 85 * patients undergoing a revision shoulder procedure * documented drug or alcohol abuse * active narcotic use within 3 months prior to surgery * neurological deficit * allergy to amide anesthetics * oxycodone intolerance * unable to take celebrex * enrollment in another clinical trial * comorbidity that is contraindicated with the administration of an interscalene block * cognitive or mental health status that interferes with study
a study of azilsartan in children from 6 to less than 16 years old with high blood pressure

Conditions: Hypertension

Summary: the main aim of this study is to check for side effects from treatment with azilsartan and how well azilsartan controls blood pressure in children from 6 to less than 16 years old with high blood pressure. the study sponsor will not be involved in how the participants are treated but will provide instructions on how the clinics will record what happens during the study. during the study, participants with high blood pressure will take azilsartan tablets or azilsartan granules once a day according to their clinic's standard practice. the study doctors will check for side effects from azilsartan for up to 12 months after treatment starts.


Eligibility criteria:
inclusion criteria 1. participants aged 6 years or older and less than 16 years 2. participants with hypertension exclusion criteria participants with contraindications to azilsartan.
frontal cognitive control functions before and after percutaneous catheter procedures in treatment of atrial fibrillation

Conditions: Neurobehavioral Manifestations; Atrial Fibrillation

Summary: atrial fibrillation is a common arrythmia. it is an independent risk factor for stroke. there for anticoagulation therapy is used for atrial fibrillation patients. alternatively, left atrial appendix closure can be used, if the risk for bleeding complications is deemed greater than the possible antithrombotic benefit of anticoagulation medication. up to 70% of ischemic complications can be prevented with anticoagulation therapy, and left atrial appendix closure seems to have comparable results. also left atrial catherter ablation (laca) is gaining popularity as a therapeutic intervention for atrial fibrillation. however, the procedure is associated with 0,5-1% perioperative risk of clinically evident transient ischemic attack (tia) or stroke. while the incidence of clinically evident ischemic complications remain relatively low, recent data suggest that 13%-20% of patients undergoing laca are affected by post-operative neurocognitive dysfunction (pocd) 90 days after ablation. the goal of the study is to improve detection of subtle brain dysfunction after cardiac interventions by employing an experimental executive reaction time (rt) test along with eeg recording in aims to improve objective detection of subtle brain dysfunction assumed to underlie persistent cognitive, somatic, and affective complaints reported by patients who have undergone atrial fibrillation ablation.


Eligibility criteria:
inclusion criteria: * age 50-70 * undergoing left atrial catheter ablation or percutaneous left atrial appendix closure procedure * in the ablation group, patients will qualify for the study if they have symptomatic atrial fibrillation (ehra classification 2-4) and if their risk of thromboembolic complications with cha2ds2vasc scale is low (0-2 points). exclusion criteria: * age under 18 or over 70 years. * contraindication for anticoagulation therapy (in ablation group), * previous neurological or psychiatric disorder. * significant visual problem that can't be corrected for, * problems with upper arm/hand use, that would make the execution of the test difficult. * normal contraindications for the ablation and appendix closure procedures.

Keywords: neurobehavioral manifestations pocd atrial fibrillation anti-arrhythmia atrial appendage closure
mutation analysis and copy number changes of kras and braf gene in taiwanese cases of biliary tact adenocarcinoma

Conditions: Biliary Tract Adenocarcinoma

Summary: cholangiocarcinoma is a fatal malignant neoplasm originating from biliary tracts and constitutes about 5-10% of primary liver cancers, characterized by a poor prognosis. high prevalence in southeast and eastern asia has been observed. at present, the cellular and molecular mechanisms leading to oncogenesis of cholangiocarcinoma remain unclear. the ras gene product has a key role in controlling cell growth and differentiation through its intrinsic gtpase activity. point mutations that activate the ras protein and its downstream cascade have been observed in human tumors. both kras and braf are members of the ras-raf-mek-erk-map kinase pathway which mediates cellular response to growth signals. somatic kras mutations are found at high rates in leukemia, colon cancer, pancreatic cancer and lung cancer. studies from european and japanese groups have recently described that activating kras/ braf mutations may play a role in the carcinogenesis of cholangiocarcinoma of the biliary tracts, but our preliminary data demonstrated low frequency of kras and braf mutation in the same tumor as well as the results from thailand. in this study, the investigators hypothesize copy number changes rather than genetic mutation of either kras or braf genes may be the key findings of taiwanese cases of the adenocarcinoma from the biliary tracts.


Eligibility criteria:
inclusion criteria: * the patients diagnosed as biliary tact adenocarcinoma.