cyrilzakka/clinical-trials huggingface dataset:
The Effect of Simple Basal Insulin Titration, Metformin Plus Liraglutide for Type 2 Diabetes With Very Elevated HbA1c - The SIMPLE Study

The aim of this clinical trial is to assess and compare the effect of insulin detemir in combination with liraglutide and metformin versus insulin detemir in combination with insulin aspart and metformin in subjects with very uncontrolled Type 2 Diabetes (A1c \> 10%).

The aim of this study is to compare a GLP-1 plus basal insulin and metformin treatment regimen to a basal-bolus plus metformin treatment regimen in patients with very uncontrolled (HbA1c\>10%) type 2 diabetes. The investigators will compare the two regimens with respect to efficacy in improving glycemic control, rate of hypoglycemia, change in weight, effect on patient quality of life, treatment burden, physician time, as well as healthcare related cost. The investigators hypothesize that at 26 weeks from randomization the two treatment regimens will have similar percentage of patients reaching A1c levels \<7.0%, while more patients on the GLP-1 plus basal insulin strategy will achieve the composite end point of A1c levels \<7.0% without severe hypoglycemia or significant weight gain.

Eligibility Criteria:
Inclusion Criteria:

1. Clinical diagnosis of type 2 diabetes with confirmed HbA1c level \>10% at time of enrollment, regardless of prior or current treatment regimens, or time since diagnosis.

Exclusion Criteria:

1. Age \<18 as the feasibility and safety of this treatment regimen should be first established in the adult population; if successful, a subsequent pediatric study will be proposed;
2. Type 1 diabetes as purposefully withholding meal-time insulin is contraindicated;
3. Clinical state requiring inpatient admission/treatment;
4. Contraindication or strong cautions to any of the study medications:

   1. Creatinine above 1.4 mg/dl for women and 1.5 mg/dl for men (per metformin label)
   2. History of lactic acidosis (per metformin label)
   3. Advanced hepatic or cardiac disease (per metformin label)
   4. Age \>80 years (per metformin label)
   5. Chronic alcohol use (\>14 drinks/week)
   6. History of pancreatitis (per liraglutide label)
   7. Personal or family history of medullary thyroid cancer or MEN syndrome (per liraglutide label)
   8. Pregnancy and lactation (per liraglutide label)
5. Any serious or unstable medical condition as it would interfere with treatment assignment as well as outcome measurement;
6. Any scheduled elective procedures/surgeries;
7. Active infections, including osteomyelitis;
8. Not willing to participate, unable to keep projected appointments, unwillingness to receive injectable treatment; unwillingness to perform 7-point glucose profiles over 2 consecutive days the weeks prior to Randomization (visit 1)and the week prior to visit 6
9. Non English speaking.
Comparison of Platelet Inhibition With Adjunctive Cilostazol Versus High Maintenance-Dose Clopidogrel According to Hepatic Cytochrome 2C19 Allele (CYP2C19) Polymorphism

The purpose of this study was to determine the impact of adjunctive cilostazol on platelet inhibition in carriers and non-carriers of the loss-of-function CYP2C19 allele.

The additional platelet inhibition with clopidogrel, a thienopyridine inhibitor of the platelet P2Y12 adenosine diphosphate (ADP) receptor, has reduced the risk of ischemic events after coronary stent implantation. Because of inter-individual variability in platelet response to clopidogrel, a significant proportion of suboptimal platelet inhibition has been reported. In addition, persistent residual platelet reactivity measured with platelet function testing has shown the association with the cardiovascular outcomes after percutaneous coronary intervention(PCI).

Various clinical factors and genetic polymorphisms have been studied to predict the degree of antiplatelet response to clopidogrel. Interestingly, recent studies found that carriers of the loss-of-function hepatic cytochrome (CYP) 2C19 allele had significantly lower levels of the active metabolite of clopidogrel, diminished platelet inhibition, and a higher rate of major adverse cardiovascular events than did non-carriers, in the setting of PCI and acute coronary syndrome(ACS). These findings raise the need of solutions to overcome enhanced post-clopidogrel platelet reactivity by the influence of the loss-of-function CYP2C19 allele. Increasing the dose of clopidogrel and new potent P2Y12 antagonists(such as prasugrel) may be alternative antiplatelet regimens in patients with the loss-of-function CYP variant.

Cilostazol reversibly induces platelet inhibition via its blockade of phosphodiesterase (PDE) type 3 and is catalysed mainly by CYP3A. A recent study demonstrated that adjunctive cilostazol to dual antiplatelet therapy (triple antiplatelet therapy) intensified platelet inhibition as compared with a high maintenance-dose (MD) of 150 mg/day. Therefore, triple antiplatelet therapy could also be an alternative antiplatelet therapy to improve platelet inhibition and clinical outcomes in carriers of CYP2C19 mutant allele.

Eligibility Criteria:
Inclusion Criteria:

1. The patient must be at least 18 years of age
2. Significant coronary artery stenosis (\> 70% by visual estimate)
3. Elective coronary stent implantation

Exclusion Criteria:

1. Acute myocardial infarction
2. Hemodynamic instability active bleeding and bleeding diatheses
3. Oral anticoagulation therapy with warfarin,use of peri-procedural glycoprotein IIb/IIIa inhibitors
4. Contraindication to antiplatelet therapy
5. Left ventricular ejection fraction \< 30%
6. Leukocyte count \< 3,000/mm3, platelet count \< 100,000/mm3
7. AST or ALT ≥ 3 times upper normal
8. Serum creatinine level ≥ 2.5 mg/dL
9. stroke within 3 months
10. Noncardiac disease with a life expectancy \< 1 year
11. Inability to follow the protocol
International Registry on the Use of the CytoSorb Adsorber

Registry on the use of the CytoSorb® adsorber in ICU patients.

The aim of this registry is to record the use of CytoSorb® under real life conditions in as many cases as possible (preferably all or, at least, in a representative sample). All CytoSorb® applications in different clinical settings and in all patients who are treated with this technology in Germany, Austria and Switzerland (target population) are planned to be included.

The objectives of the registry are collection of real-life data on a broad scale, their centralized, structured and comprehensive documentation, and a controlled data exchange. The gathered information will be used to augment the knowledge on the clinical efficacy of the technology, to optimize the quality of its therapeutic application, and to identify and promptly handle possible complications related to the use of CytoSorb®. The registry will record all relevant information in the course of product use, e.g. diagnosis, comorbidities, course of the condition, treatment, concomitant medication and clinical laboratory parameters.

The registry will inform physicians of different medical specialties about the range of possible applications of CytoSorb® and invite them to contribute their own experiences to the registry. This is done by giving them access to their own data and to the results of periodic analyses (for contributing participants), and via publications of the results (for participants and external interested parties)

The CytoSorb® registry will provide the data base for justified and optimized decisions. An active form of data collection where data is prospectively collected by qualified staff is particularly suited for this purpose.

Registry data might help closing knowledge gaps and open practical issues. Due to the patient group's heterogeneity, the registry can identify sub-groups, assess their risk-benefit-profile and examine their safety profile. Registry data are absolutely essential for assessing a therapy's significance within the healthcare landscape.

Institutions that contribute data to the registry benefit in several ways: They will obtain a continuous retrospective feedback of their own results, their data will be periodically compared with data from other participating sites, and they will get access to regularly published analyses of the results of all participants. On the basis of these data, they can establish a quality monitoring and optimize their use of CytoSorb®.

The planned endpoints allow for a comprehensive description of CytoSorb® efficacy in terms of several indication-relevant aspects. Together with the monitoring of application safety, these data build the basis for establishing benchmarks that promote a higher treatment quality.

Eligibility Criteria:
Inclusion Criteria:

* Use of the CytoSorb® adsorber
* Age ≥ 18 years
* Signed informed consent

Exclusion Criteria:

- none
Comparison of Vaccination Routes: Subcutaneous Versus Intramuscular Application of FSME-Immun®

FSME-Immun® is registered for application into the muscle. This study investigates if application under the skin leads to a comparable immune response.

Tick-borne encephalitis (TBE) vaccine (FSME-Immun®) is registered for intra-muscular application. Due to medical reasons (e.g. anticoagulant therapy, adipositas) intra-muscular application is not always possible. The aim of this clinical trial is to investigate whether a comparably good immunogenicity can be achieved via the subcutaneous vaccination route. Thus humoral and cellular immune responses after intramuscular and subcutaneous TBE vaccination in healthy volunteers will be compared.

Eligibility Criteria:
Inclusion Criteria:

* completed primary TBE immunization + at least one booster immunization
* adults of both sexes between 18 and 60 years of age
* willingness to sign written informed consent form

Exclusion Criteria:

* age \< 18 and \> 60 years
* prior TBE infection
* pregnancy and breast feeding
* acute infection on day of inclusion (day 0), (body temperature \> 37,9°C)
* concomitant medications: systemic cortisone therapy, chemotherapy, immunosuppressive therapy 4 weeks prior to or during study
* administration of other vaccines 4 weeks before/after day 0
* planned surgery within 2 weeks before/after TBE booster vaccination
* specific immunotherapy (Hypo-/Desensibilisation) 14 days before/after vaccination
* any contraindication to administration of FSME-Immun® vaccine according to manufacturer's instructions
* history of malignant disease within the last 5 years
* autoimmune diseases
* drug addictions
* plasma donors
* receipt of blood transfusions or immuno globulins within 3 month before study entry
Optical Guided Sentinel Node Biopsy for Staging of Vulvar Cancer (I)

The aim of this study is to investigate whether Sentinel Node biopsy can be performed without the use of lymphoscintigraphy and with ICG as a mono-tracer in women with vulvar cancer, unifocal tumor \< 4 cm (clinical stage IB and II). Further, to investigate the accuracy of combined PET-CT and ultrasound (US) of the groins with US-guided biopsy of suspicious lymph nodes for the identification of macro-metastases in women with vulvar cancer, unifocal tumor \< 4 cm.


Eligibility Criteria:
Inclusion Criteria:

* Patients with primary vulva cancer, FIGO stage IB (tumor \< 4 cm)
* Patients with unifocal recurrence in the vulva (tumor \< 4 cm) located on the side where the patient is surgically naïve in the groin

Exclusion Criteria:

* Prior irradiation of the vulva or groins
* Prior SNB or inguinal lymphadenectomy in the relevant groin
* Known allergy to ICG or iodine (ICG contains 5% sodium iodine)
Effect of Light Color on Stress, Anxiety, and Psychological Well-being During Nonstress Test in Pregnant Women at Risk

Purpose of the research:

To determine the effect of light color on stress, anxiety, and psychological well-being during the Nonstress Test in at-risk pregnant women. This research was planned as a single-blind randomized controlled experimental type study by comparing separate groups in the form of experiment-placebo control. Data will be collected with the Introductory Information Form, Psychological Well-being Scale, Perceived Stress Scale (PSS/PSS-14), State Trait Anxiety Inventory (STAI). The NST device is used to follow up pregnant women in the last 3 months of pregnancy, first monthly, then every two weeks and once a week. In other words, the procedure is routinely performed on every pregnant woman who comes for control. It is a device that shows the well-being of the baby and whether the mother has contractions. It is attached to the pregnant woman's abdominal area and does not cause any harm. It is not an invasive procedure. Pregnant women in the last 3 months of pregnancy who come to have NST for follow-up will be randomly selected and divided into 2 groups. A lamp with adjustable light level with Unit Unit Ut-383 Mini Luxmeter (Light Meter) will be placed in the intervention and control groups and the light level of the lamp will be adjusted to 100 lux. NST will be taken under cold (bluish white) light for the control group and under medium warm white (daylight white) light for the intervention group. Pre-test before the application and post-test after the application will be applied. The application is an invasive application that will not disturb the pregnant woman.


Eligibility Criteria:
Inclusion Criteria:

* Being at risk of pregnancy,
* being in the last trimester of pregnancy,
* being a volunteer.

Exclusion Criteria:

* Having any problem that prevents communication (such as not knowing Turkish, having hearing, speaking and understanding disorders),
* being on psychiatric treatment (pharmacotherapy or psychotherapy),
* having a disease in their eyes that prevents them from seeing
Preoperative Epidural Labor Analgesia and Postoperative Pain

Parturients who undergo emergency Cesarean section (C-sec) after experiencing labor pain are likely to develop pain-induced central sensitization. The investigators hypothesized that those without epidural labor analgesia undergoing subsequent emergency C-sec would experience more severe postoperative pain or require more analgesia after C-sec compared to those with epidural labor analgesia. Thus, the investigators conducted this retrospective study by grouping parturients undergoing emergency C-sec after experiencing labor pain into two groups (epidural labor group and no epidural labor group) and those undergoing elective C-sec aimed to compare the effect of epidural labor analgesia on postoperative pain severity and analgesic consumption.


Eligibility Criteria:
Inclusion Criteria:

* Cesarean section(C-sec) under spinal anesthesia

Exclusion Criteria:

* Patients without accurate medical records
* Failure of epidural analgesia
Prospective, Single-arm, Multicenter Study for Evaluation the Safety and Effectiveness of the ALEX Stent in a Real-world Setting of Percutaneous Coronary Interventions in Patients With Coronary Heart Disease

To evaluate the safety and effectiveness of the ALEX stent in a real-world setting of percutaneous coronary interventions in patients with coronary heart disease.

Prospective, multicenter, non-randomized study designed to enroll up to 60 subjects to evaluate the safety and effectiveness of the cobalt-chromium sirolimus eluting coronary stent ALEX in a real-world setting of percutaneous coronary interventions in patients with coronary heart disease.

Eligibility Criteria:
Inclusion Criteria:

Clinical Inclusion Criteria:

* \> 18 years of age
* Patient must provide written informed consent prior to procedure using a form that is approved by the local Ethics Committee
* clinical diagnosis of Stable Angina, Unstable Angina or Myocardial Infarction without ST elevation (NSTEMI) or Myocardial Infarction with ST elevation provided the expiry of 72 hours of the onset of symptoms and stable clinical and hemodynamical condition the Patient with patent postinfarcion artery (TIMI 3) and indications for PCI and next stage of revascularization in the other vessels
* earlier effective supply of others lesions in others vessels in case of multivessels disease
* female of childbearing potential must have a negative pregnancy test within 7 days prior to enrolment and utilize reliable birth control for 12 months after enrolment

Angiographic Inclusion Criteria

* target lesion stentosis must be \> 70% (visual estimate)
* Patient eligible for PCI treatment with the ALEX stent system (vessel diameter in range of 2.5 to 4.0 mm and length of lesion that allows to cover a single stent with maximum length of 30 mm in visual evaluation)

Exclusion Criteria:

Clinical Exclusion Criteria

* anticipated inablility of the patient to comply with 12 months of antiplatelet treatment (e. g. elective non-cardiac surgery following stenting, drug intolerance etc.)
* acute or chronic renal failure (serum creatinine \> 2 mg%, GFR \< 60 ml/min/1.73m2)
* left ventricular ejection fraction (LVEF) \< 40%
* cardiogenic shock
* short life expectancy (\< 1 year)
* any significant medical condition which in the investigator's opinion may interference with the Patient's optimal participation in the study
* current participation in another drug or device clinical trail in which there no be reached the primary endpoint or which clinically interferences with trail's enpoints

Angiographic Exclusion Criteria

* chronic total occlusion
* calcified lesion which cannot be successfully dilated
* location of lesions in the winding vessels where there is no possibility of OCT imaging
* target stenosis located in venous or arterial bridge
* unprotected left main coronary disease with \> 50% stenosis
Pharmacokinetics and Pharmacodynamics of Pentobarbital in Neonates, Infants, and Children Following Open Heart Surgery

This medication is used for procedural sedation and sedation for diagnostic imaging. The purpose of this study is to find out what happens to pentobarbital in the body after it is given to children who have had heart surgery.

This clinical trial of pentobarbital admistered as a bolus dose for procedural or imaging seddation will determine the PK of the drug in neonates, infants,, and children who are postoperative from cardiac surgery. Pediatric patients hsopitalized in the CICU who would receive IV bolus doses of pentobarbital as standard of care are eligible.

Eligibility Criteria:
Inclusion Criteria:

* Will receive intravenous pentobarbital for procedural/imaging sedation as standard of care
* Age(Neonates, Young Infants, Older Infants, and Children Up to 6 years old)
* Diagnosis either postop from cardiac surgery or requrie sedation with IV pentobarbital as standard of care
* Adequate liver function tests
* Informed consent

Exclusion Criteria:

* Pregnant or lactating females
* Parents/guardians or subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.
Yoga Training and Retinal Vasculature With Parkinson's Disease

This study will compare the impact of a novel high-speed, cued yoga program to a standard yoga program on retinal microvasculature, cognition and neuromuscular function in persons with Parkinson's disease.


Eligibility Criteria:
Inclusion Criteria:

1. Parkinson's disease (H\&Y 1, 2, and 3) confirmed by pretest administration of the UPDRS,
2. 55-90 years of age,
3. Montreal Cognitive Assessment \> 17.

Exclusion Criteria:

1. Uncontrolled cardiovascular or neuromuscular diseases that prevent participation in a training program;
2. cerebrovascular disease;
3. documented HIV infection or other immunodeficiency syndrome;
4. any systemic inflammatory or autoimmune conditions such as rheumatoid arthritis, systemic lupus erythematosus, or other serious concomitant medical illness;
5. a history of ocular surgeries (except for cataract surgery more than 6 months ago) or other ocular diseases;
6. bilateral moderate or severe cataracts;
7. refractive errors of myopia, hyperopia and/or astigmatism more than 6.0 Diopters.
Free Fatty Acid Induced Insulin Resistance

This study aims to explore time-dependent effects of lipid infusion an intramyocellular lipid metabolites and the induction of impaired insulin signaling.

Increased availability of free fatty acids impairs glucose disposal in young healthy humans. Patients with type 2 diabetes have reduced whole body glucose disposal, increased ectopic lipid deposition in skeletal muscle and the liver and impaired mitochondrial function. Recent studies suggest that lipid metabolites such as diacylglycerol (DAG), ceramides and long-chain acyl-coA represent the active mediators inducing insulin resistance. Possible targets are DAG-sensitive Proteinkinase C (PKC θ, PKC ε) which inhibit the insulin signaling cascade and ceramides which interfere with the insulin signaling cascade at Proteinkinase B/AKT. Prior studies raised controvesial evidence, thus, it is yet unclear, whether DAG or ceramides are the primary agents inducig lipid-induced insulin resistance. Therefore, the current study aims to explore the time course of the appearance of intramyocellular lipid compunds during lipid infusion in parallel assessing markers of impaired insulin action.

Eligibility Criteria:
Inclusion Criteria:

* non-diabetic (OGTT), no family history of diabetes, BMI\<30 kg/m2, age: 20-55 years, no medication

For the athletes group additionally:

* VO2max \> 60ml/kg/min for males and VO2max \> 45ml/kg/min for females Active in endurance-exercise activities, 3 times a week for at least 2 years Stable level of training for at least 3 months

Exclusion Criteria:

* acute illness within the last 2 weeks, autoimmune diseases, renal insufficiency (creatinine\> 1.5 mg/dl), cardiovascular diseases, anemia (Hb\< 12g/l), donation of blood within the last 4 weeks before the study, thyroid diseases, pregnancy, smoking, night-shift working (disturbed circadian rhythm), defective coagulation or wound healing, cancer, allergy against soja products
Effect of a Synbiotic "Probiotical®/Bactecal® " in Asthma

It is a randomized double blind placebo control study. One hundred severe asthmatic patients will receive "Probiotical ®/Bactecal®" each day during 3 months and will be evaluated before and 1-3-6 months after in order to assess the impact of the synbiotic on the lung function, the exhaled nitric oxide value, the inflammatory blood and sputum profiles, the bronchial reactivity, the microvascular health and the quality of life and asthma control. The hypothesis is that, as these patients are not optimally controlled, the synbiotic could have an impact by decreasing the inflammation state at local and systemic level and then improve the quality of life and the asthma control. Indeed, synbiotic have been shown to possess beneficial effects on the immune system.

Thirty percent of asthmatic patients are not well controlled even with an optimal treatment. There is then a need for new therapeutics allowing a better asthma control. Synbiotic (association of probiotics and prebiotics) have been shown to have anti-inflammatory properties as well as immunomodulatory activities. Moreover, synbiotic appeared to be very well tolerated and safe.

One hundred severe asthmatic patients (ACQ\> 1.5 and beclomethasone \> 200 µg per day) will receive "Probiotical ®/Bactecal®" (3 pills a day, content: Lactobacillus, Bifidobacterium et Streptococcus thermophilus, 18 billion of bacteria per pill) or a placebo during 3 months.

They will be evaluated before and 1-3-6 months after the first administration and different tests will be realized:

* lung function tests (spirometry, lung volumes, diffusing capacity)
* exhaled nitric oxide value (FeNo, linked to airway eosinophilia)
* blood tests: leucocyte count, c reactive protein, fibrinogen. Plasma and serum will be kept for inflammatory mediators measurements.
* sputum induction: leucocyte count and mediators measurements using the sputum supernatant and sputum cells.
* bronchial reactivity (bronchial challenge test)
* microvascular health: to assess the glycocalyx state, see: http://glycocheck.com/ for details.
* questionnaires: asthma control test (ACT), asthma control questionnaire (ACQ), asthma quality of life questionnaire (AQLQ ).

Eligibility Criteria:
Inclusion Criteria:

* severe asthma (ACQ \>1.5 and treatment = minimum 200 µg beclomethasone) and stable treatment for at least 3 months.

Exclusion Criteria:

* treatment not stable
* exacerbation state
* infection