cyrilzakka/clinical-trials huggingface dataset:
OCT- Versus Angiography-guided Paclitaxel Drug-Coated Balloon Angioplasty in De Novo Coronary Artery

OCT allows precise evaluation of intimal injury after lesion preparation and may improve the acute results and long-term outcomes after paclitaxel drug-coated balloon angioplasty. This prospective multicenter cohort study aims to assess the efficacy and safety of OCT- versus angiography-guided paclitaxel drug-coated balloon angioplasty in middle-sized de novo coronary artery after lesion preparation with scoring balloon.


Eligibility Criteria:
Inclusion Criteria:

1. 18 to 85 years old
2. Patients have ischemic symptoms or evidence of myocardial ischemia (inducible or spontaneous) in the presence of a stenosis of at least 50% in a native coronary artery, including stable angina, unstable angina, or silent ischemia.
3. Reference vessel diameter \>2.5 mm, and \<4.0 mm.
4. Lesion length of \<22 mm
5. Written informed consent

Exclusion Criteria:

1. Myocardial infarction within 4 weeks, including ST-elevation myocardial infarction and non-ST-elevation myocardial infarction
2. Cardiogenic shock (systolic arterial pressure \<90mmHg), congestive heart failure (NYHA or Killip≥3)
3. Chronic kidney disease (eGFR \<30 ml/min)
4. Lesion length \>22 mm, or vessel diameters of \<2.5 mm or \>4.0 mm
5. Stents covering a major side branch (\>2 mm)
6. Left main lesion
7. Graft lesion
8. Aortic-coronary ostial lesion
9. In-stent restenotic lesion
10. Chronic total occlusion
11. Severe calcified lesions.
12. Visible angiographic thrombus
13. Severe comorbidities: eg. malignancy (life expectancy \<2 years)
Modic Changes and Associated Features in Southern European Chronic Low Back Pain Patients

To assess: a) The prevalence of Modic changes and other findings on lumbar magnetic resonance imaging (MRI), among Spanish adult chronic LBP patients, b) Patient characteristics and radiological findings associated with Modic changes.

Ten radiologists from six hospitals across six cities in Spain, consecutively recruited 487 adult patients (263 women and 224 men) in whom lumbar MRI had been prescribed for low back pain lasting ≥ 3 months. Patients' characteristics and imaging findings were assessed through previously validated instruments. A multivariate logistic regression model was developed to assess the features associated with Modic changes.

Outcome measures were: Gender, age, body mass index (BMI), life time smoking exposure, degree of physical activity, and image features (disk degeneration, type and extension of Modic changes, disk contour, annular tears, spinal stenosis and spondylolisthesis).

Eligibility Criteria:
Inclusion Criteria:

* Patients between 35 and 50 years of age having a diagnosis of chronic low back pain (of 3 or more months' duration, and including sciatica and lumbar cytalgia), who get a prescription for an MRI.

Exclusion Criteria:

* Racial characteristics suggesting a non-Spanish origin; central nervous system pathology (with or without treatment);
* Diagnosis or suspicion of systemic disease (inflammatory disease such as rheumatoid arthritis, or infections).
Metformin Induces a Dietary Restriction-like State in Human

The fact that metformin treatment has been associated with reduced risk of cancer and cardiovascular disease raises the possibility of a beneficial role of metformin for other age-related diseases. The actions of metformin resemble the effects of calorie restriction (CR) to some extent, and microarray analyses have shown that metformin induces a gene expression profile that aligns with that of CR in animal. The aim of the study is to investigate whether metformin treatment can induce dietary restriction-like state in human.

Sixty overweight subjects will be included in this study, and participants will be divided 3 groups (20 cases in each group)including metformin group (0.85, twice daily), standard diet group, and CR group. All subjects will be treated 6 months. At the end of this study, blood samples and muscle samples will be obtained.

Blood samples will be obtained from all individuals. blood lipids, inflammation markers, insulin, glucose, leptin,adiponectin, ala aminotransferase, asp aminotransferase, creatine phosphokinase,lactate dehydrogenase, alkaline phosphatase,bilirubin, cyclo-oxygenase, citrate synthase, renal function, leukocyte telomere length ratio, and telomerase activity will be measured before and after the treatments.Also, hyperinsulinemic-euglycemic clamp will be performed before and after the treatments. Muscle samples will be obtained by biopsy for 9 individuals (3 cases from each group) at the end of the study. Microarray analysis will be performed for the gene expression profile from the muscle samples. Other protein expressions such asadenosine monophosphate-activated protein kinase (AMPK), peroxisome proliferator-activated receptor coactivator 1a (PGC-1a) activity,will be checked by Western blot.

Eligibility Criteria:
Inclusion Criteria:

* Overweight
* Male

Exclusion Criteria:

* Female
* Obesity
* Using any other drugs
* \< 18 years old
* \> 60 years old
* Mental disorders
* Surgery history for abdomen
Patient Safety in the Operating Room: Helsinki Declaration Implementation in Ukraine

Athe study to evaluate the implementation of the components of the Declaration of Helsinki in Ukrainian hospitals, as well as other safety measures during surgeries.

A study was conducted from May 2021 to September 2021 at the Ukrainian hospitals. The study design was approved by the Ethical Committee at Bogomolets National Medical University. The survey was conducted by filling out a standard Google form. The link to the survey was distributed on the official page of the Association of Anesthesiologists of Ukraine, through social networks Facebook and Instagram on the official webpages of the Department of Surgery, Anesthesiology and Intensive Care of the Institute of Postgraduate Education of NMU. O.O. Worshipers. A total of 174 respondents took part in the survey.

To conduct the survey, we formed a questionnaire of 24 items. The questionnaire was designed to ensure sufficient collection of data from respondents on demographics, awareness of the Declaration, and the use in the everyday practice of the measures recommended in it to promote patient safety. However, the structure of the questionnaire allowed people to fill it in a short time. We also provided respondents with more descriptive and detailed answers to some questions if they wished. The survey was conducted in Ukrainian. Practitioners-anesthesiologists, as well as heads of departments, employees of departments, were invited to participate in the survey.

The survey results were imported into a Microsoft Excel spreadsheet for further analysis. Simple descriptive statistics were used for demographic data and numerical answers to individual questions. The answers, which included the free text were grouped by topic using simple qualitative techniques.

Eligibility Criteria:
Inclusion Criteria:

* experienced anesthesiologists

Exclusion Criteria:

* anesthesiologists out of practice
Radiation Therapy and High-Dose Corticosteroids in Treating Older Patients With Primary CNS Non-Hodgkin's Lymphoma

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Combining radiation therapy with a corticosteroid, such as dexamethasone, may be an effective treatment for non-Hodgkin's lymphoma.

PURPOSE: Phase II trial to study the effectiveness of radiation therapy and high-dose dexamethasone in treating older patients with primary CNS non-Hodgkin's lymphoma.

OBJECTIVES:

* Assess the effectiveness of high-dose dexamethasone after whole-brain radiotherapy in maintaining response and preventing recurrence in elderly patients with primary central nervous system non-Hodgkin's lymphoma.
* Assess the toxic effects of this regimen in these patients.
* Assess the survival rate of patients after this regimen.
* Identify the anatomic rates of recurrence and frequency of systemic involvement in patients treated with this regimen.
* Identify the factors that appear to be associated with outcome in patients treated with this regimen.

OUTLINE: Patients undergo whole-brain radiotherapy (WBRT) daily 5 days a week for 4.5 weeks. Beginning 30 days after WBRT is completed, patients receive high-dose dexamethasone IV on days 1-5 during course 1 and on day 1 only during all subsequent courses. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Patients are followed at 1 month after radiotherapy, every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 28 patients will be accrued for this study within 6 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Pathologically confirmed non-Hodgkin's lymphoma with intracranial lesions

  * Intraocular lymphoma eligible, if not sole site of disease
  * No occult systemic lymphoma
* Measurable or evaluable disease by CT scan or MRI
* No neoplastic meningitis or gross spinal cord involvement

PATIENT CHARACTERISTICS:

Age:

* 70 and over

Performance status:

* ECOG 0-3

Other:

* No prior history of lymphoma
* No other active malignancy except basal cell skin cancer or carcinoma in situ of the cervix
* HIV negative
* No active peptic ulcer disease
* No uncontrolled diabetes mellitus
* No active pancreatitis
* No active bleeding
* No poorly controlled major psychiatric illness
* No serious uncontrolled infection

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* No prior bone marrow transplantation

Chemotherapy:

* No prior chemotherapy

Radiotherapy:

* No prior radiotherapy to the brain or head and neck region

Surgery:

* No prior transplantations (renal, hepatic, or cardiac)
Study of the Effect of Diquafosol Tetrasodium Ophthalmic Solution, 2% Versus Placebo in Dry Eye Subjects (P08634)

The purpose of this pilot study is to evaluate the effect of diquafosol tetrasodium Ophthalmic Solution, 2% in dry eye subjects.


Eligibility Criteria:
Inclusion Criteria:

* Provide written informed consent prior to any study procedures being performed.
* Have a best corrected visual acuity (BCVAof +0.7 or better.
* Have a history of dry eye (keratoconjunctivitis sicca) in both eyes
* Have ongoing dry eye disease, in the same qualifying eye or both eyes.

Exclusion Criteria:

* Have previously had LASIK refractive surgery.
* Use of topical ophthalmic medications, preps, gels and lid scrubs during study.
* Have had penetrating intraocular surgery in the past 90 days.
* Have had other ocular surface surgery (e.g., refractive, pterygium) within the past year.
* Have a diagnosis of an on-going ocular infection, clinically significant blepharitis, lid margin inflammation, Stevens-Johnson syndrome or pemphigoid.
* Any serious ocular systemic disease or uncontrolled medical condition.
* Exposure to any investigational drug within 30 days of study start.
Drug Interaction Study Between Dorzagliatin and Empagliflozin

This is a Phase 1, open-label, sequential, multiple-dose, drug interaction study of glucokinase activator dorzagliatin and empagliflozin in subjects with T2DM. Pharmacokinetics and pharmacodynamics when dorzagliatin and empagliflozin given alone and in combination will be studied.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects diagnosed with T2DM within at least 3 months prior to screening
2. Male and/or female subjects between the ages of 30 and 65 years, inclusive;
3. Body Mass Index (BMI) of 19 to 38 kg/m2, inclusive, at screening;
4. Fasting C-peptide test result \>0.3 nmol/L (\>0.90 ng/mL);
5. HbA1c ≥7% and ≤10.5%;

Exclusion Criteria:

1. Fasting blood glucose at screening or Day -1 ≤110 or ≥270 mg/dL ;
2. Type 1 diabetes mellitus;
3. Reported incidence of severe hypoglycemia within 3 months prior to screening;
4. Known contraindications to empagliflozin;
5. Clinically significant gastrointestinal disorder;
6. History or symptoms of clinically significant cardiovascular disease;
7. History of more than three urinary tract infections and/or more than three genital fungal infections in the last 12 months;
8. Reported history of clinically significant central nervous system disease including within one year prior to screening;
9. Reported history of liver disease;
10. Reported history of clinically significant renal disease;
11. Estimated glomerular filtration rate (eGFR) ≤60 mL/min/1.73m2;
12. Acute or chronic metabolic acidosis, including diabetic ketoacidosis;
13. Known or suspected malignancy;
14. Any reported hypersensitivity or intolerance to empagliflozin;
15. Antidiabetic treatment with insulin, sulfonylureas, thiazolidinediones or GLP-1 agonist within 3 months prior to screening;
16. Systolic blood pressure \<90 or \>160 mmHg or diastolic blood pressure \<60 or \>100 mmHg at screening;
17. A hospital admission or major surgery within 90 days prior to screening;
18. Uncontrolled hypertriglyceridemia \>500 mg/dL;
19. Positive blood screen for HIV, HBsAg, or hepatitis C antibody;
20. Positive pregnancy test result;
21. Treated with any investigational drugs within 6 weeks prior to screening;
22. Reported history of prescription drug abuse;
23. Reported history of alcohol abuse
24. Reported history of donation or acute loss of blood during the 90 days prior to screening;
Building Electronic Tools To Enhance and Reinforce CArdiovascular REcommendations - Heart Failure (BETTER CARE-HF)

Building Electronic Tools To Enhance and Reinforce CArdiovascular REcommendations - Heart Failure (BETTER CARE-HF) is a pragmatic, cluster-randomized, three-arm intervention trial that will compare the effectiveness of two targeted clinical decision support (CDS) intervention tools (best practice alert (BPA) and automated in-basket massage) to inform providers when a patient with heart failure and reduce ejection fraction (HFrEF) is not on appropriate medical therapy, as compared to usual care.

An estimated 68,000 deaths per year nationwide can be attributed to gaps in care for patients with heart failure and reduced ejection fraction (HFrEF), with the majority being due to lack of mineralocorticoid receptor antagonists (MRA). Despite proven benefits in randomized trials, class I guideline recommendations, and published clinical performance measures, patients with HFrEF are often not on guideline-directed medical therapy (GDMT). While successful interventions for improvement in prescription of GDMT have often included multidisciplinary approaches with dedicated staff, the relatively high cost of hiring additional personnel has led to an interest in electronic health record (EHR)-based interventions. Prior studies on EHR-based interventions in this arena have mainly been conducted in the inpatient setting, which is limited to one encounter during acute hospitalization, a setting often complicated by renal dysfunction or hypotension that can limit prescription of MRA. The development and study of outpatient EHR-based alerts for HFrEF GDMT are needed. Two types of outpatient EHR-based interventions include best practice alerts (BPA) and automated in-basket messages. Both of these methods have limited data, with some studies showing benefit and others demonstrating provider fatigue and burnout. To our knowledge, there is no study that has directly compared these different types of EHR-based interventions.

BETTER CARE - HF is a pragmatic, cluster-randomized, three-arm intervention trail that will compare the effectiveness of two targeted CDS intervention tools (BPA and automated in-basket message) as compared to usual care on the primary outcome of MRA prescription at end of study period.

Eligibility Criteria:
Inclusion Criteria:

* Cardiologist visit
* Transthoracic echocardiogram with the most recent EF \>= 40%

Exclusion Criteria:

* Hypotension: SBP \< 95
* Hyperkalemia: most recent K \> 5.1, or any K \>5.5
* Renal dysfunction: eGFR \< 30
* Ventricular assist device
* Hospice care
* Cardiac amyloid
Exercise Training in Adults With Corrected Tetralogy of Fallot

In this controlled trial, patients with tetralogy of Fallot will be randomized to either interval training, continuous training, or usual care groups.

Patients after surgical correction of tetralogy of Fallot (cTF) have impaired exercise tolerance as compared to healthy age-matched individuals. In this controlled trial, patients with cTF will be randomized to either interval training, continuous training, or usual care.

The aim of the study is to compare the effect of interval vs. continuous exercise training on:

i) exercise capacity ii) vascular function iii) arrhythmogenic potential iv) parameters of inflammation, hemostasis and heart failure severity v) health-related quality of life adults with cTF

Eligibility Criteria:
Inclusion Criteria:

* congenital tetralogy of Fallot surgically corrected in childhood

Exclusion Criteria:

* contraindications for exercise training,
* uncontrolled dysrhythmias,
* uncontrolled heart failure (New York Heart Association (NYHA) stage IV),
* unstable coronary or other arterial disease,
* intellectual development disorder,
* pregnancy.
Effectiveness of NEURAPAS Balance in Children With Nervous Restlessness

Purpose: To document data on effectiveness of NEURAPAS® balance (NPB) in the treatment of nervous restlessness in children aged 6 to 12.

Each patient is treated with NPB. No placebo group is established. Course and severity of symptoms is documented by a questionnaire on 13 common symptoms of nervous restlessness and a Visual Analogue Scale (VAS). A standardized questionnaire (Parent Child Behaviour Checklist (CBCL/4-18)) is completed. Choice and doses of therapy are at the respective physician's discretion. The planned treatment and observation period is 2 - 4 weeks.

Purpose: To document data on effectiveness of NEURAPAS® balance (NPB) in the treatment of nervous restlessness in children aged 6 to 12.

Patients and methods: A prospective, non-interventional, non-randomized, observational study conducted in German pediatric practices. Each patient is treated with NPB. No placebo group is established. As subjective criteria to document course and severity of symptoms, a questionnaire on 13 common symptoms of nervous restlessness and a Visual Analogue Scale (VAS) is used. As an objective criterion, a standardized questionnaire (Parent Child Behaviour Checklist (CBCL/4-18)) is completed. Choice and doses of therapy are at the respective physician's discretion. The planned treatment and observation period is 2 - 4 weeks.

Eligibility Criteria:
Due to the design as an Observational Study no inclusion or exclusion criteria are named. The included patient group is described under "Cohort / Group".

Observational Criteria:

* age 6 - 11 (extremes included)
* nervous restlessness and/or
* agitated depression and/or
* affective disorders

Exclusion Criteria:

* patients \<6 and \>12 years of age
BRIDGE Device for Post-operative Pain Control

Auricular neurostimulation is a potential novel and non-invasive method of pain control following liver transplantation in a growing patient population with the probability of significant impact on economics and morbidity. The investigators propose a pilot study to investigate the effects of auricular neurostimulation in patients receiving a liver transplantation. The investigator will investigate the effects of auricular neurostimulation with this novel device and compare it to the current standard of care for pain management following liver transplantation.

This is a prospective, randomized study to determine the efficacy of the BRIDGE device in reducing pain and opioid use in patients following liver transplantation. Subjects will be randomized in a 1:1 ration to one of the below groups:

Group 1: BRIDGE device will be placed prior to start of the surgery with standard of care pain control analgesia

Group 2: Subjects will receive the standard of care pain control analgesia

Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria:

  * ≥18 years of age but \<70 years of age
  * Actively listed for isolated liver transplantation
  * Subject or legally authorized representative able to sign informed consent
  * Not currently treated with opioids or any medications that may interact with opioids
  * English speaking
  * Willing and able to participate and consent to this study

Exclusion Criteria:

* Diagnosis of acute liver failure or primary sclerosing cholangitis (PSC)
* Anticipated that the subject will require a new roux-en-y hepaticojejunostomy
* Current use of opioid use or other substance abuse.
* Chronic pain disorders
* Need for regional anesthesia (regional nerve blocks or epidurals)
* Adhesive allergy/sensitivity
* Subject admitted to the ICU at the time of transplant
Evaluation of the Efficacy of Combination Treatment With Anakinra and Pegsunercept in Improving Rheumatoid Arthritis

The purpose of this study is to evaluate the effect of anakinra (IL-1 ra) and pegsunercept (PEG sTNF-RI) when they are used together in improving the signs and symptoms of rheumatoid arthritis. The study will also evaluate the safety of the combination treatment and its effect on slowing down bone and joint destruction due to rheumatoid arthritis. The results will be compared to the effect when only 1 single medication (anakinra or pegsunercept) is used.


Eligibility Criteria:
* diagnosed with rheumatoid arthritis for at least 6 months
* must be taking methotrexate \* must not take DMARDS other than methotrexate during the study
* must not have had previous treatment with and protein-based TNF-alpha inhibitor (eg. etanercept, infliximab, PEG sTNF-RI, or D2E7)
* must not have had previous treatment with anakinra
* subjects must meet tender and swollen joint requirements at screening, have morning stiffness, and/or have elevated acute phase reactants
Acupuncture in Low Anterior Resection Syndrome Treatment

Acupuncture has it's role in treating patients with fecal incontinence and diarrhea-predominant irritable bowel syndrome. There is no trial or case-report assessing it's role in treatment of Low anterior resection syndrome.

Colorectal cancer is common in Western countries. For thirty years rectal cancer treatment is standardized: patients are undergoing low anterior resection with mesorectal excision +/- (chemo)radiotherapy. Unfortunately around 80% of patients undergoing low anterior resection will experience complex bowel dysfunction including fecal incontinence, soiling, urgency, incomplete evacuation, fragmented defecation and impaired rectal sensation known as low anterior resection syndrome (LARS) causing a "toilet dependence" which severely affects quality of life.

Still there is no standardized treatment for LARS.

Eligibility Criteria:
Inclusion Criteria:

* patients over 18 year
* signed written consent
* patients experiencing major low anterior resection syndrome
* patients at least one year following the surgery

Exclusion Criteria:

* allergy to stainless steal
* implanted pacemaker
* current skin infection
* needle phobia
* metastatic disease to the central nervous system (brain, spinal cord)
* at the same time, application of smecta, dicetel, cisapride or traditional Chinese medicine;