cyrilzakka/clinical-trials huggingface dataset:
Safety and Efficacy of Fospropofol vs Propofol During Invasive Mechanical Ventilation.

The goal of this clinical trial is to compare the safety and efficacy of fospropofol and propofol during sedation in invasively mechanically ventilated patients in the Anesthesia Intensive Care Unit (AICU). Specific objectives include the following:

* Evaluate the sedative effects of fospropofol and propofol in invasively mechanically ventilated patients. Compare the sedative effects of the two medications using relevant clinical indicators and scoring tools, such as the Richmond Agitation-Sedation Scale (RASS).
* Compare the safety of fospropofol and propofol during sedation. Monitor medication-related adverse reactions, such as respiratory depression, hypotension, arrhythmias, headache, injection site pain, and assess the differences in adverse reaction incidence between the two medications.
* Compare the characteristics of recovery from sedation between PPD and propofol. Focus on the time from sedation to emergence from sedation and compare the differences in recovery time between the two medications.

Participants will be sedated with fospropofol or propofol during invasive mechanical ventilation.


Eligibility Criteria:
Inclusion Criteria:

1. Aged 18-65 years old
2. Intubation and mechanical ventilation \<12h before enrollment
3. Expected to require continuous invasive ventilation and sedation less than 6h after admission to anesthesia intensive care unit (AICU).
4. Signed informed consent

Exclusion Criteria:

1. parturient, childbirth or lactating mothers
2. acute severe neurological disease or coma
3. chronic renal failure
4. previous mechanical ventilation \>12h
5. severe liver dysfunction (Child-Pugh score C)
6. BMI \>30kg/m2 (\>90kg)
7. dying
Phenotypic and Genotypic Characterization of Patients With Dysmetabolism in Greenland

The goal of this clinical trial is to perform a detailed description of the feno- and genotype of people living with type 2 diabetes and severe obesity who are linked to care at Steno Diabetes Center Greenland.

The main questions it aims to answer are:

* Are monogenetic diabetes variants associated with the same risk of developing late diabetic complications as other types of diabetes?
* Can genotyping and thereby personalized medicine be implemented in Greenland, and can personalized medicine lead to improved treatment?
* What is the prevalence of sleep apnea among high-risk individuals in Greenland?
* Is it possible to develop and implement a simple algorithm for the identification of sleep apnea in Greenland that can ensure treatment of severe sleep apnea?

Participants will:

* Answer WHO-5 and FOSQ-10 questionnaires regarding quality of life and functional outcomes of sleepiness
* Perform VAGUS examinations for Cardiovasculare Autonomic Neuropathy
* Clinical examination of height, weight, circumference of hip, waist and neck, Friedman tonsil and tongue score, nasal air flow, nasal septal deviation
* Blood samples for full genome sequencing

The phenotypic and genotypic characteristics of dysmetabolism in the Greenlandic Inuit population are yet to be described in detail. However, the unique interaction of genetic and environmental factors in this population and its effect on disease development calls for further investigation. Therefore, we aim to examine how metabolic diseases manifest and progress distinctively in this population compared to Western populations.

The study employs whole genome sequencing, with a focus on identifying variants in the TBC1D4 gene, which is linked to muscular insulin resistance, and HNF1α, associated with MODY (Maturity-onset Diabetes of the Young) diabetes. In addition, the prevalence of Obstructive Sleep Apnea (OSA) in relation to metabolic disorders is examined. Our methodology combines genetic analysis with clinical evaluations to understand the impact of these genetic factors on disease manifestation and potential complications.

The findings will likely offer a unique perspective on the genetic influence on metabolic diseases in the Greenlandic Inuit population, highlighting the significance of novel genetic variants for disease management and prevention. The study investigates the relationship between metabolic disorders and OSA, and aims to describe how diagnosis and treatment of OSA can be introduced in an Arctic setting. This research emphasizes the need for genotype-aware treatment approaches and culturally tailored healthcare strategies, not only for the Greenlandic Inuit but also as a model for personalized medicine approaches in other populations. The insights gained here contribute to a deeper understanding of metabolic diseases, potentially influencing future global healthcare strategies.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes and/or morbid obesity (BMI \>40)
* Over 18 years old

Exclusion Criteria:

* Does not speak either English, Danish or Greenlandic
Perfusion Index in Anesthesia

In patients under general anesthesia the investigators wish to investigate association and covariance between a peripheral perfusion index as obtained by Radical 7 monitor (Masimo, Irvine, CA, USA) and more traditional hemodynamic parameters, ie. invasive blood pressure and SV as obtained by LiDCO rapid monitor (LiDCO Ldt., London, UK)


Eligibility Criteria:
Inclusion Criteria:

* Patients for elective and sub-acute surgical repair of para-oesophagal hernia.
* Willingness to participate

Exclusion Criteria:

* Patient refusal
Home-Based Executive Function Training Intervention For Attention-Deficit/ Hyperactivity Disorder-prone Children

This study aims to investigate the effectiveness of a home-based executive function training Intervention on children's ADHD symptoms, executive function and parents' parenting stress.


Eligibility Criteria:
Inclusion Criteria:

* 1.SNAP-IV scale, inattention or hyperactivity-impulsivity scale score \> 1.2
* 2.Parents who could understand or lacking of access to computers and the Internet
* 3.Parents can commit to ensuring full participation and complete the training and test evaluations in full compliance with the researcher's requirements
* 4.Children and their parents consent to the study

Exclusion Criteria:

* 1.Children or parents with severe organic encephalopathy and other severe mental disorders
* 2.Parents or children are receiving ADHD-related behavioral treatment
* 3.Parents or children who dropped out before the study started or in the middle of the study
A Study of Insulin Efsitora Alfa (LY3209590) Compared With Insulin Degludec in Participants With Type 2 Diabetes Currently Treated With Basal Insulin

The reason for this study is to see if the study drug insulin efsitora alfa (LY3209590) is safe and effective in participants with Type 2 diabetes that have already been treated with basal insulin. The study consists of a 3-week screening/lead-in period, a 78-week treatment period and a 5-week safety follow-up period. The study will last up to 86 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Have been diagnosed with Type 2 diabetes according to the World Health Organization (WHO) criteria treated with basal insulin
* Are receiving ≥10 units of basal insulin per day and ≤110 units per day at screening
* Have HbA1c value of 6.5% - 10% inclusive, at screening
* Have a Body mass index (BMI) less than or equal to 45 kilogram/square meter (kg/m²)
* Have been treated with one of the following stable insulin regimens at least 90 days prior to screening:

  * once daily U100 or U200 of insulin degludec
  * once daily U100 or U300 of insulin glargine
  * once or twice daily U100 of insulin detemir, or
  * once or twice daily human insulin NPH
* acceptable non insulin glucose lowering therapies may include 0 to up to 3 of the following:

  * dipeptidyl peptidase (DPP-4) IV inhibitors
  * SGLT2 inhibitors
  * metformin
  * alphaglucosidase inhibitors or,
  * Glucagon-Like Peptide-1 (GLP-1) receptor agonists
  * Participants must be willing to stay on stable dose throughout the study

Exclusion Criteria:

* Have Type 1 diabetes mellitus
* Have acute or chronic hepatitis, cirrhosis, or obvious clinical signs or symptoms of any other liver disease, except Nonalcoholic Fatty Liver Disease (NAFLD)
* Estimated glomerular filtration rate (eGFR) \<20 milliliters/minute/1.73 square meter (m²)
* Have active or untreated malignancy
* Are pregnant
* Have a significant weight gain or loss the past 3 months
* Have received anytime in the past 6 months, any of the following insulin therapies:

  * prandial insulin
  * insulin mixtures
  * inhaled insulin
  * U-500 insulin, or
  * continuous subcutaneous insulin infusion therapy
* Have had any of New York Heart Association Class IV heart failure or any of the following CV conditions in the past 3 months:

  * acute myocardial infarctions
  * cerebrovascular accident (stroke), or
  * coronary bypass surgery
* Gastrointestinal: have undergone gastric bypass (bariatric) surgery, restrictive bariatric surgery (Lap-Band) or sleeve gastrectomy within 1 year prior to screening
Intravenous Fish Oil in Critically Ill Cardiac Patients

A large body of evidence has accumulated showing that n-3 PUFAs exert extensive cardiac effects. The development of commercial solutions of FO opens perspectives for therapeutic applications in patients with acute cardiac conditions.the 3 following hypotheses will be addressed in patients requiring cardiac surgery under cardiopulmonary bypass or after myocardial infarction:perioperative /post-PTCA intravenous fish oil modifies the composition of membrane phospholipids in platelets and cardiac cells, blunts the physiological response to cardiac surgery/myocardial infarction, and reduces the incidence of arrhythmias, and reduces the occurrence of systolic dysfunction.

A. Randomized trial in 40 cardiac surgery patients Early rapid infusion of fish oil (3 times in 24 hours) in cardiac surgery patients.

B. Randomized trial 20 myocardial infarction patients (abandonned) Continuous infusion of the same dose over 24hrs in the myocardial infarction patients

Additional trial in healthy volunteers (investigating physiological changes after cardiac study):

-Open trial in 8 healthy lean volunteers to investigate the impact of the same 0.6 g/kg FO dose IV (Week 1: 3hrs), and then orally on week 2, on platelet n-3 PUFA incorporation, platelet function, heart rate and peak flow response to stress test.

Eligibility Criteria:
Inclusion Criteria:

* Coronary artery disease requiring elective surgical repair under cardiopulmonary bypass
* Acute myocardial infarction requiring ICU management

Exclusion Criteria:

* Absence of consent
* Ventricular ejection fraction \< 35%
* Beating heart surgery or emergency surgery
* Hypercholesterolemia \> 5 mmol/l
* Thrombolysis
* Chronic steroid therapy
* Acute or chronic renal failure prior to surgery (plasma creatinine \> 150 umol/l)
* Chronic coagulation disorder
* Premenopausal female
* Consumption of more than 3 times fish per week
Effectiveness of Oral Insulin in Unstable Type 1 Diabetes Patients

The intent of the proposed study is to assess the potential of oral insulin to mitigate diabetic instability and reduce the frequency and severity of hypoglycemic episodes in patients with type 1 diabetes. Restoring hepatic glycogen stores is critical for the normalization of counter-regulation to hypoglycemia in these patients. Oral insulin can provide a means to increase portal insulin levels, shift the ratio of insulin/glucagon in favor of glycogenesis while sparing the patient the risk of hypoglycemia due to peripheral hyperinsulinemia


Eligibility Criteria:
Inclusion Criteria:

* Type 1 diabetes mellitus
* Male or female aged 18-50 years inclusive
* Body weight between 50-100kg and BMI between 18 and 30 kg/m2
* Diagnosed 6 or more months ago, unstable diabetes with frequent episodes of hypoglycemia
* No other medical problems

Exclusion Criteria:

* History or presence of clinical significant gastrointestinal pathology or symptoms, liver or kidney disease or any condition that might interfere with the absorption, distribution, metabolism or excretion of the drug
* Positive pregnancy test or lactation
* Lack of family support
* Unwilling or unable to follow the study protocol
* Concurrent medical problems
Detoxification of the Liver In PSC (Dolphin)

This study is a clinical trial being done to investigate the efficacy of drug BRS201 (hydroxocobalamin) as a treatment in patients with primary sclerosing cholangitis. Participation in this study will take 8 weeks long and the study is structured as a cross-over study in which participants will take the study drug for 4 weeks and a placebo drug for 4 weeks in a randomized order in the form of an oral medication. Participation may also involve receiving an IV dose of the medication. The study will require participants to attend 9 study visits, all of which will be remote. Participation will involve taking an oral medication twice daily, tracking the medication in a log, and getting blood drawn and giving a stool sample for a few lab tests throughout the study. For the lab tests, a research nurse will visit the participant in-home for the convenience of the participant.


Eligibility Criteria:
Inclusion Criteria:

* A diagnosis of PSC for at least 6 months based upon cholangiography (ERCP or MRCP) demonstrating intrahepatic and/or extrahepatic biliary strictures, beading or irregularity consistent with PSC.
* ALP \> 1.5 times the upper limit of normal (ULN) at screening.
* Subject must either be on a stable dose of ursodeoxycholic acid for \> 6 months prior to screening or have been discontinued \> 4 weeks prior to screening (enrollment of patients who are on UDCA will be limited to 60% of all enrolled patients).

Exclusion Criteria:

* Anticipated need for liver transplant within one year as determined by Mayo PSC risk score
* Evidence of decompensated liver disease such as variceal bleeding, ascites, or hepatic encephalopathy.
* Evidence of advanced liver disease including MELD score \> 10, bilirubin \> 3.0, platelet count \< 100,000; or INR \> 1.4
* Concomitant chronic liver disease including alcohol related liver disease, chronic hepatitis B or C infection, haemochromatosis, Wilson's disease, alpha1-antitrypsin deficiency, non-alcoholic steatohepatitis, autoimmune hepatitis, or primary biliary cholangitis
* Secondary causes of sclerosing cholangitis
* Patients who have a confirmed malignancy or cancer within 5 years except non-melanoma skin cancers
* Treatment with any investigational agents, within two months or 5 half-lives of the investigational product, whichever is longer.
* Active illicit drug or more than moderate alcohol consumption.
* Evidence of bacterial cholangitis within 6 months of enrollment
* In patients with Ulcerative Colitis, or, if Crohn's disease, a need for additional therapy at time of screening.
* Chronic kidney injury (eGFR \< 60)
* Pregnancy or lactation
* Uncontrolled hypertension with a systolic BP \> 140 and a systolic BP \> 90
* Prohibited medications: current use of vitamin C and prednisone
* Patients with a history or risk of cardiovascular conditions, including arrhythmia, long QT syndrome, congestive heart failure, stroke, or coronary artery disease
* Patients with a history of kidney stones
* Congenital or acquired immunodeficiencies
* Other comorbidities including: diabetes mellitus, systemic lupus
* An episode of acute cholangitis within 4 weeks of screening
Half Dose of Prasugrel and Ticagrelor in Acute Coronary Syndrome (HOPE-TAILOR)

East Asian patients will be required optimal dose of newer P2Y12 inhibitors (prasugrel or ticagrelor) to determine the safer treatment and better outcome. Whether lower dose of these regimens are more adequate for clinical practice in Korea is unclear. Therefore, the investigators aim to evaluate efficacy and safety of half dose of new oral P2Y12 inhibitors in Korean patients with acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI).

In recent years, newer oral P2Y12 receptor blockers (prasugrel or ticagrelor) have been strong recommendations for management of patients with ACS undergoing (PCI). These drugs provided more profound inhibitory effects than clopidogrel, which could lead to marked reduction in ischemic events, with relatively increase in bleeding complication, specific to low body weight, especially in women and East Asian patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients present with acute coronary syndrome undergoing primary PCI.
* Patients receive DAPT (conventional dose of P2Y12 inhibitors+aspirin) at least 1 month.
* Patients provide written informed consent prior to enrollment.

Exclusion Criteria:

* Low body weight (\<60kg).
* History of transient ischemic attack or stroke.
* History of upper gastrointestinal bleeding in recent 6 months.
* Renal dysfunction defined as serum creatinine \> 2.5 mg/dl
* Severe hepatic dysfunction defined as serum transaminase \> 3 times normal limit
* On treatment with oral anticoagulant (Vitamin K antagonists, dabigatran, rivaroxaban).
* Bleeding tendency.
* Thrombocytopenia defined by platelet \< 100,000/ml.
* Anemia defined by hemoglobin \< 10 g/dl.
* Current treatment with drugs interfering with CYP3A4 metabolism (to avoid interaction with Ticagrelor): Ketoconazole, itraconazole, voriconazole, clarithromycin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, atazanavir, and telithromycin.
* Known severe chronic obstructive pulmonary disease or bradycardia (sick sinus syndrome (SSS) or high degree AV block without pacemaker protection).
* Contraindication for study drugs.
Impact of Telemedicine in the Rate of Readmission for COPD. Project CRONEX 3.0

The prevalence of COPD is high and suppose one of the first public health problem in the world. It has a high morbidity and mortality and healthcare costs. The economic aspect is directly related to hospitalization, accounting for 45-50% of total expenditure of COPD. Patients with frequent exacerbations generate most of the cost.

In these patients, there are not standardized treatments or monitoring in a medium or long term, but it seems reasonable that the combination of various interventions (programs self-care, active role of health professionals in consultations, home programs, group visits, establishment action plans for patients, use of communication technologies or social networks) may improve many patient outcomes.

The hypothesis of our work will be to introduce telemedicine platform to establish action plans for the patient, recognition of symptoms and exacerbations, treatments for the exacerbations, training material on COPD, smoking and inhalation therapy, establishment of a fast and fluid communication with pulmonologist, with the purpose of responding to various health problems that patients with COPD (exacerbator phenotype or ACO phenotype) may have. We will study the impact of this tool to reduce the rate income or readmission for the patients with COPD, analyzing it from the perspective of cost-effectiveness.


Eligibility Criteria:
Inclusion Criteria:

1. COPD, which after evaluation of its clinical history, belonging to exacerbator phenotype (chronic bronchitic / emphysema) or mixed phenotype ("COPD-asthma") readmission (2 or more income in the previous year) and are stable least six weeks before inclusion in the study.
2. Age over 18 years
3. The patient or caregiver should be able to use the tablet type telematic tool for tracking and monitoring.

Exclusion Criteria:

1. Patients with severe comorbidity grade IV heart failure, renal failure on hemodialysis or active neoplasia
2. Patients with difficulties phone coverage
3. Patients with lack of adequate social and family support.
4. Patients who do not grant informed consent
Physical Activity in Patients After Aortic Valve Replacement (Valve-ex)

A structured and supervised, 3-month physical activity intervention in patients after aortic valve replacement due to severe stenosis, accompanied by examination of cardiac size and function, exercise capacity and endothelial function before, three and six months after operation; comparison with a non-intervention control group.


Eligibility Criteria:
Inclusion Criteria:

* Patients with severe valvular aortic stenosis and indication for valve replacement

Exclusion Criteria:

* Coronary heart disease with indication for additional bypass surgery Leading insufficiency of the valve
* Age \< 65 or \> 75
* Diseases or conditions leading to additional risks during physical activity (e.g. diabetes, arthrosis, obstructive pulmonary disease)
Treating Primary Sclerosing Cholangitis and Biliary Atresia With Vancomycin

The purpose of this study is twofold. First, is to determine whether vancomycin is effective in the early treatment of Biliary Atresia (BA) and Primary Sclerosing Cholangitis (PSC), and if so, by what mechanism. Secondly, to characterize human intestinal microbial communities and their interactions with the host.

Investigators hope to learn to characterize human intestinal microbial communities (microbiome: the collection or collectivity of microorganisms) using molecular methods, examine the mechanisms of interaction between host and microbiome using genomic approaches, and determine how the microbiome both preserves local health and promotes pathology. Investigation will focus on primary sclerosing cholangitis, biliary atresia, as well as states of health. The composition of the associated microbiome will be assessed based on ribosomal DNA and RNA sequences, and attention will be given to richness (diversity), evenness (relative abundance), and variation with respect to time, person, and anatomic niche. Host response at the adjacent mucosal surface will be assessed based on genome-wide gene expression patterns. In addition, changes in the metabolites of the blood will be analyzed.

To see if the antibiotic vancomycin, when used for the early treatment of Biliary Atresia (BA) and Primary Sclerosing Cholangitis (PSC) is effective treatment for these diseases. Investigators hope to learn what effect Vancomycin has on the bacteria that are present in stool, body fluid or intestinal tissue on someone who has BA and PSC and if so by what mechanism.

Eligibility Criteria:
Inclusion Criteria:

* Persons who have primary sclerosing cholangitis, biliary atresia, a chronic intestinal disorder or who are undergoing upper or lower endoscopy.
* Persons who have primary sclerosing cholangitis or biliary atresia who are good candidates for vancomycin therapy.

Exclusion Criteria:

* Patients that have taken antibiotics and/or immunomodulators within the last 3 months will be excluded as this will alter the original bacterial flora.
* Females who are pregnant may not participate.