Kornimate/medical-research-clean huggingface dataset:
sitagliptin for the treatment of type 2 diabetes

Conditions: Type 2 Diabetes

Summary: patients newly diagnosed with t2d will be recruited and will receive sitagliptin treatment for 3 months. the gut microbiome of the participants before and after the treatment and the effectiveness of sitagliptin treatment on type 2 diabetes will be evaluated.

the dipeptidyl peptidase-4 inhibitor sitagliptin is a classic anti-diabetic drug(1) and is widely applied to both scientific research and clinical trial(2-6). this clinical trial aims to study the effectiveness of sitagliptin treatment in t2d patients and related change of gut microbiome. 50 patients newly diagnosed with t2d will be recruited. with patient's informed consent, patient-related vital signs (such as age, height, weight, body mass index), laboratory indicators (including glycated hemoglobin, glycated albumin, low-density lipoprotein, total cholesterol, triglycerides), fasting blood glucose, insulin levels and insulin resistance index (homa-ir)(7) will be recorded and analyzed. the feces of the patients will be collected to analyze the gut microbiome. all of the patients will receive the sitagliptin treatment for 3 months. the gut microbiome of the patients and the effectiveness of sitagliptin treatment on diabetes will be evaluated at indicated times during follow-up.

Eligibility criteria:
inclusion criteria: * patients 18-65 years old newly diagnosed with type 2 diabetes * hba1c ≥ 7% exclusion criteria: * the positive of diabetes antibodies * anti-diabetic drugs therapy before participation * pancreatitis * coronary artery disease * liver function impairment * renal function impairment * history of intestinal surgery * chronic hypoxic diseases (emphysema and cor pulmonale) * infectious disease * hematological disease * systemic inflammatory disease * cancer * pregnant * ingesting agents known to influence glucose or lipid metabolism; * any antibiotics or probiotics in the past three months prior to the study.
correlation of right atrial strain with pulmonary hypertension, right ventricular function and outcome in pediatric patients

Conditions: Pulmonary Hypertension

Summary: this observational study aims to assess correlation of right atrial strain measured by two-dimensional speckle tracking echocardiography with intraoperatively measured pulmonary artery pressures, other indices of right ventricular function and short term postoperative outcome.


Eligibility criteria:
inclusion criteria: * undergoing elective cardiac surgery for congenital heart disease with left to right shunt * prior evidence of pulmonary arterial hypertension on preoperative echocardiography. exclusion criteria: * neonates * children with history of previous cardiac surgery, * hemodynamic instability * non-sinus rhythm
a study to assess the immunogenicity and safety of csl's 2009 / 2010 formulation of enzira® vaccine in healthy volunteers

Conditions: Influenza

Summary: the purpose of the study is to assess the efficacy and safety of csl's 2009/2010 formulation of the enzira vaccine.


Eligibility criteria:
inclusion criteria: * males or females aged ≥ 18 years at the time of providing informed consent * participants are capable of understanding the purposes and risks of the study and are able to provide written informed consent * willing and able to adhere to all protocol requirements * able to provide a sample of approximately 17 ml of venous blood on two separate occasions without undue distress/discomfort * females of child bearing potential (i.e. ovulating, pre-menopausal, not surgically sterile) must be abstinent or be willing to use a medically accepted contraceptive regimen for the duration of the study exclusion criteria: * known hypersensitivity to a previous dose of influenza vaccine or allergy to eggs, chicken protein, neomycin, polymyxin, or any components of the enzira® vaccine * clinical signs of an active infection and/or an elevated oral temperature (≥ 38.0°c) at study entry * a clinically significant medical or psychiatric condition * a confirmed or suspected immunosuppressive condition * history of seizures * history of guillain-barré syndrome * vaccination with a seasonal influenza virus vaccine or with an experimental influenza virus vaccine in the 6 months preceding study entry * currently receiving treatment with radiotherapy or cytotoxic drugs, or have received such treatment within the 6 months preceding administration of enzira® vaccine * currently receiving systemic glucocorticoid therapy (excluding topical or inhaled preparations) or have received such therapy within the 3 months preceding study entry * currently receiving immunoglobulins and/or any blood products or have received such treatment within the 3 months preceding the administration of enzira® vaccine * currently participating in another investigational study or recent study participation ending 3 months preceding administration of enzira® vaccine * currently receiving treatment with warfarin or other anticoagulants * evidence or history of substance or alcohol abuse within the 12 months before study entry * females of child bearing potential who are planning to become pregnant or planning to discontinue contraceptive precautions during the study period * females who are pregnant or lactating * any issues that, in the opinion of the investigator, would render the subject unsuitable for study participation
prophylactic use of milrinone after congenital heart surgery in infants

Conditions: Low Cardiac Output Syndrome; Cardiac Surgical Procedures; Infant

Summary: this randomized, multi-center, double-blinded, placebo-controlled study is designed to evaluate the efficacy and safety of milrinone compared with placebo in participants after corrective surgery for congenital heart disease. participants will be randomized in a 1:1 ratio within 90 minutes after arriving in the intensive care unit (icu), to receive either intravenous milrinone or placebo for 36 hours. participants will be stratified according vasoactive inotrope score after arriving in the icu.


Eligibility criteria:
inclusion criteria: * age younger than 12 months * without pre-operative low cardiac output syndrome * bi-ventricular repair of congenital heart disease involving cardiopulmonary bypass * informed consent obtained from each participant's parent or guardian exclusion criteria: * a body weight \<2 kg * prematurity (birth \<36 weeks postconceptual age) * renal dysfunction ( creatinine\>1.5mg/dl 48 hours before surgery) * low cardiac output syndrome or hypotension on arrival to icu from or * cardiopulmonary resuscitation before surgery * platelet count\<80,000/mm3 before surgery * left ventricular outflow tract obstruction before surgery * ventricular arrhythmia before surgery * without femoral artery catheter before arriving in the icu * consent was withdrawn by participants' parent or guardian.
distribution of medication disposal packets - acute opioid prescribing

Conditions: Orthopedic Surgery; Neurosurgery; Surgery; Opioid Use; Opioid Misuse

Summary: many prescription opioids following surgery are left unused and are at risk of being misused or diverted. encouraging proper disposal is important, yet motivating this behavior remains challenging as patients must understand the risks of opioids, the benefits of disposal, and identify opportunities and places to dispose of them safely. alternative disposal techniques can improve disposal rates but may be lost or forgotten. applying behavioral economics techniques may lower the barriers and promote disposal. the objective is to test the effect of a specifically timed, mailed, at-home kit on disposal rates following surgery.

a pragmatic, cluster-randomized quality improvement study embedded in an existing automated, post-operative text messaging program to capture patient-reported outcomes (e.g., pain score, opioid use, ability to manage pain) and disposal as part of usual care. it was approved by the university of pennsylvania institutional review board with a waiver of informed consent. all patients, 18 years or older, undergoing an orthopedic or urologic procedure and prescribed an opioid were approached and consented via text messaging. patients without access to a text message capable device or non-english speaking were excluded. participants were block randomized to usual care or a mailed at-home disposal packet. usual care consisted of a text message hyperlink to nearby disposal locations. intervention participants were mailed an at-home disposal packet timed to arrive between post-operative days four and seven based on prior data collection on reported use. the disposal packet (disposerx inc.) contains a powder that sequesters unused opioids in a polymer gel. patients self-reported disposal via the automated system.

Eligibility criteria:
inclusion criteria: * adults 18 or older * undergoing an orthopedic or urologic procedure * prescribed an opioid * sms capable mobile device * english speaking exclusion criteria: * under 18 * does not own a text message capable mobile phone * non-english speaking

Keywords: opioid prescribing mobile health quality improvement learning health systems
notify 2: an evaluation of the impact of notification of incidental coronary artery calcium on statin rates

Conditions: Coronary Artery Disease

Summary: the primary objective is to estimate the impact of notification of primary care provider and patient of at least moderate incidental coronary artery calcification (cac) on a prior non-gated chest ct on statin prescription rates at 4 months among patients without a clinical history of atherosclerotic cardiovascular disease not actively on statin therapy. this study will determine if notifying patients and their primary care clinician about an existing finding will influence shared decision-making around statins between patients and their primary care clinician.


Eligibility criteria:
inclusion criteria: 1. age greater than or equal to 18 and less than 85 2. non-gated chest ct from 1/1/2016-6/30/2020 with algorithm screening estimating cac score of at least 100 agatston units with radiologist confirmation of moderate or severe cac 3. encounter with palo alto va affiliated primary care since 2020 exclusion criteria: 1. prior diagnosis of coronary artery disease, peripheral artery disease, or cerebrovascular disease 2. dementia 3. metastatic cancer or active cancer undergoing chemotherapy 4. ct coronary angiogram since 2016 5. invasive coronary angiogram since 2016 6. cac scan since 2016 7. statin therapy within prior 6 months 8. prior ezetimibe or pcsk9 inhibitor therapy 9. prior rhabdomyolysis with statin therapy 10. schizophrenia 11. substance abuse disorder (alcohol, amphetamines, cocaine, opioids) 12. hospice 13. pregnancy
understanding dexmedetomidine in neonates after open heart surgery

Conditions: Tetrology of Fallot; Heart Ventricle; Hypoplastic Left Heart

Summary: the purpose of this study is to determine what happens to dexmedetomidine in the body after it has been given to a newborn after heart surgery. we want to learn how long the drug stays in the body, how the drug is metabolized by the body, and how well the medicine works at a particular dose or amount.

this is a single center, dose escalation study of a single bolus dose of dexmedetomidine followed by a continuous infusion for up to 24 hours in neonates who are immediately post-op from cardiac surgery, and require tracheal intubation with mechanical ventilation in the post-op period. pediatric populations may benefit from the favorable pharmacodynamic effects of this medication.

Eligibility criteria:
inclusion criteria: * patients must be less than or equal to 1 month old. * postconceptual age must be \> or equal to 37 weeks on the day of surgery. * postoperative from cardiac surgery with tracheal intubation/mechanical ventilation in the immediate post-op period. * planned tracheal extubation within 24 hrs post-op. * adequate renal function (serum creatine \< or equal to 1.5mg/dl) * adequate liver function (alt \< or equal to 165 u/l) * isolated heart surgery * informed consent exclusion criteria: * patients who have received another investigational drug since birth. * patients receiving continuous infusions of muscle relaxants in the post-op setting. * pateints who have a positive blood culture without a subsequent negative culture of other evidence of ongoing serious infection. * patients who show signs and symptoms of elevated intracranial pressure. * post-op hypotension defined by post conceptual age. * pre-existing bradycardia defined by age * heart block * weight \< 2kg * patients who, in the opinion of the investigator, are not appropriate candidates for an investigational drug study

Keywords: precedex open heart surgery dexmedetomidine sedation
feasibility study of photovaporisation of prostate with a limitated length of catheterization of 3 hours

Conditions: Benign Prostatic Hypertrophy

Summary: benign hypertrophy of the prostate (bph) is the most frequent pathology in the urinary tract of middle-aged men. in recent years, to enable bph treatment with larger volumes and to reduce the risk of hemorrhage known to be associated to the transurethral resection of prostate treatment, transurethral photovaporisation of the prostate (pvp ) with the greenlight (gl) xps 180 w was developed. therefore, the question arises to maximally reduce the length of catheterization to facilitate outpatient surgical management of prostate adenoma. in the investigators study, the investigators propose to evaluate the failure rate of an early removal of the catheter 3 hours post-operative after a pvp procedure with gl 180 w/xps in selected patients on general anesthesia or spinal anesthesia. to this end, the investigators realize a national multicenter prospective study including 300 patients. the effectiveness of this model of management is defined by absence of a need for re-catheterization in the post -operative period of 24 hours.


Eligibility criteria:
inclusion criteria: 1. patients with lower urinary tract symptoms (luts ) 2. ipss≥ 15 despite medical treatment \> 1 month if monotherapy or \> 3 months if bitherapie or acute urinary retention ( rau ) non-medical after the 1st failure to remove the catheter or acute prostatitis or macroscopic haematuria of prostatic origin 3. prostate volume \> 30 cc by transrectal ultrasonography ; 4. ipss qol ≥ 3 has at inclusion ; 5. psa ≤ 4 ng / ml ; 6. if psa between 4 and 10 then psa l/t ≥25 % or negative pbp \<6 months . 7. accommodation \<50 km; 8. company available for the return at home and monitoring first post- operative night . 9. patient sign the informed consent 10. patient covered by social security or other health insurance exclusion criteria 1. post- voiding residue \> 250 cc by suprapubic ultrasound not older than \< 45 days 2. prostate volume \> 100 cc by transrectal ultrasound not older than 45 days 3. urological antecedents : o urethral stenosis or cervical disease * uti in progress * sad patient or self-catheterization * obstructive hydronephrosis + / - renal failure * vesical calculi * cancer of the prostate treated or untreated * bladder tumor associated * interstitial cystitis ( symptom or biopsy) 4. antecedent of the prostate surgery 5. neurologic bladder ( parkinsonian syndrome , multiple sclerosis , lupus, neuropathy, diabetic, cauda equina syndrome ) 6. criteria related concomitant medications that can not be stopped at least \< 48 hours before pvp with gl xps 180 w 7. contra indication for outpatient care for medical reason 8. contra indication of a product analgesic according to protocol 9. patient inability to understand and sign the informed consent as well as completing the questionnaires 10. asa score \> 3 .
a propensity score matching analysis on endovascular vs open thoraco-abdominal aortic aneurysm repair (pro-endo taaa study)

Conditions: Thoracoabdominal Aortic Aneurysms

Summary: the purpose of the registry is to compare the surgical and endovascular approaches to the treatment of thoracoabdominal aortic aneurysms.

the purpose of the study is to compare the surgical and endovascular approaches to the treatment of thoracoabdominal aortic aneurysms. in particular, the study aims at comparing the short- and mid-term mortality, morbidity and reintervention rate after open surgery or endovascular repair of thoracoabdominal aortic aneurysms in comparable cohorts of patients according to preoperative characteristics and evaluating the cost-effectiveness of both techniques, according to the eunethta core model. the study results will contribute to the creation of a hta report regarding endovascular technology to treat thoracoabdominal aortic aneurysms which will be evaluated by the appropriate health authorities.

Eligibility criteria:
inclusion criteria: * patients affected by a thoracoabdominal aortic aneurysm who received an open surgical repair (aneurysmectomy and aortic reconstruction with a surgical graft) or endovascular repair (with off-the-shelf or custom-made fenestrated/branched-endovascular aortic repair - f/bevar) between january 2013 and june 2021 at san raffaele hospital (vascular surgery unit) * adult patients ≥18 years * the patient is able to understand and sign the informed consent approved by the ethics committee of the san raffaele hospital exclusion criteria: * patients treated with a hybrid approach (open surgical retrograde revascularization of renovisceral arteries followed by aneurysm exclusion with endograft) * patients treated with other endovascular techniques besides fenestrated or branched technology (e.g., physician-modified endografts, parallel grafts). * patients with a juxtarenal or pararenal aortic aneurysm * patients treated with f/bevar for a visceral artery patch aneurysm after open thoracoabdominal repair
evaluation of the effects of omeprazole and rifampin on the pharmacokinetics of vx-548 in healthy participants

Conditions: Pain

Summary: the purpose of this study is to evaluate the pharmacokinetics and safety of vx-548 and its metabolite in the absence and presence of omeprazole or rifampin, in healthy participants.

this clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (that is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4) (a) of the public health service act and 42 cfr 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the public health service act or 42 cfr 11.24 and 11.44.).

Eligibility criteria:
key inclusion criteria: * body mass index (bmi) of 18.0 to 32.0 kilogram per meter square (kg/m\^2) * a total body weight greater than (\>) 50 kg key exclusion criteria: * history of febrile illness or other acute illness that has not fully resolved within 14 days before the first dose of study drug * any condition possibly affecting drug absorption * history of cardiovascular disease * participants of child-bearing potential other protocol defined inclusion/exclusion criteria may apply.
outcomes of drug coated balloon angioplasty, a uk real life experience from 2009 to 2015

Conditions: Ischaemic Heart Disease

Summary: this is a single center, retrospective, observational cohort study to assess the safety and efficacy of drug coated balloon (dcb) angioplasty in all forms of coronary artery disease. the investigators intend to report outcomes of all patients who received dcb angioplasty at their center during the above mentioned period for up to 10 years.

the investigators expect to assess outcomes of all patients who received drug coated balloon angioplasty treatment, which is a novel therapy as opposed to standard drug eluting stent insertion, for all types of coronary artery disease from 01/01/2009 till 31/12/2015 in their center. the investigators believe the number exceeds 1000 patients. the investigators plan to collect demographic and procedural data from their existing data base. they will request up to date follow-up events from nicor (national institute for cardiovascular outcomes research, uk) in 2017(data ending december 2016), by which time all patientswould have had minimum of 12 months follow up. the investigators plan to incorporate these findings to their data set and report the comprehensive outcomes. primary end point will be major adverse cardiac outcomes (mace) defined as a composite of death, myocardial infarction and target vessel revascularisation. secondary end points will be acute vessel closure and target lesion revascularisation. the investigators also have a long term plan of requesting follow-up events from nicor for up to 10 years, so they can report on long term outcomes of drug coated balloon treatment.

Eligibility criteria:
inclusion criteria: all patients who were treated with drug coated balloon angioplasty during 01/01/2009 - 31/12/2015 at norfolk and norwich university hospital. - exclusion criteria: -

Keywords: ischaemic heart disease coronary angioplasty drug coated balloons (dcb)
virtual world-based cardiac rehabilitation

Conditions: Cardiac Event; Telemedicine; Cardiovascular Diseases

Summary: the proposed trial is a multiphase, multicenter, non-inferiority, hybrid type 1 effectiveness, randomized controlled trial to test an innovative virtual world-based cardiac rehabilitation (cr) program, "destination cardiac rehab". the primary objectives of this study are to assess the efficacy and adherence of "destination cardiac rehab" compared to traditional center-based cr.

the proposed virtual world-based cardiac rehabilitation (vwcr) program provides a novel home-based delivery method of a cr program to address several barriers to care associated with traditional center-based cr (cbcr). this 2-arm, randomized controlled trial (rct) will rigorously assess adherence and efficacy of vwcr compared to cbcr in a 12-week (36-session) intervention that includes patient education, self-monitoring of physical activity and blood pressure, social support, and weekly telehealth visits with a cr nurse and exercise physiologist. patients with a cr eligible cardiovascular event will be recruited from 6 geographically diverse cr centers across the united states. we hypothesize that the vwcr, known as "destination cardiac rehab" will be non-inferior to cbcr as assessed by improvement in cardiovascular health and adherence to cr sessions.

Eligibility criteria:
inclusion criteria: * indication for cr according to centers for medicare \& medicaid services (cms) guidelines: myocardial infarction within the preceding 12 months; coronary artery bypass surgery; current stable angina (chest pain); heart valve repair or replacement; percutaneous transluminal coronary angioplasty (ptca) or coronary stenting; heart or heart-lung transplant; stable chronic heart failure * aged ≥18 years * basic internet navigation skills * active email address exclusion criteria: * high risk patients according to the american association of cardiovascular and pulmonary rehabilitation (aacvpr) risk stratification (e.g., sudden cardiac arrest survivor) * receiving continuous inotropic support * presence of a mechanical circulatory support device * decompensated heart failure * symptomatic valvular heart disease * uncontrolled angina * presence of hemodynamically unstable dysrhythmias (e.g., ventricular tachycardia) given safety concern of unsupervised exercise20 * pregnant (due to associated hormonal and weight changes) * non-english-speaking * visual/hearing impairment or mental disability that would preclude independent use of the vw platform