cyrilzakka/clinical-trials huggingface dataset:
Consistency of Carotid Doppler Blood Flow and Thermodilution Technique

Currently, the gold standard method to estimate CO is the thermodilution technique, pulmonary artery catheter (PAC) and PiCCO system included, however, the invasiveness and complexity of the thermodilution technique have limited their usefulness in many clinical scenarios. By measuring the carotid blood flow, continuous carotid doppler technique has been reported to noninvasively estimate cardiac output (CO) and other parameters related to cardiac contractility and fluid status in various cardiovascular disorders. However, to the best of our knowledge, few study has been reported to evaluate the consistency of this technique in cardiac surgery patients. The aim of this study is to evaluate the tracking ability of CO changes measured by continuous carotid doppler technique in cardiac surgery patients, use the thermodilution technique as the referenced.


Eligibility Criteria:
Inclusion Criteria:

* adult cardiac surgery patients
* with thermodilution technique monitoring
* mechanical ventilation

Exclusion Criteria:

* life threatening arrhythmia
* severe valve regurgitation
* left ventricular ejection fraction less than 30%
* patients with mechanical circulatory support
A Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of ACE-031 (ActRIIB-IgG1)in Healthy Postmenopausal Volunteers

Single center, randomized, single dose study to evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic effects of ACE-031 in healthy postmenopausal volunteers


Eligibility Criteria:
Key Inclusion Criteria:

1. Subject is a postmenopausal woman, 45-75 years old (inclusive)
2. Subject has a body mass index (BMI) of \> 18.5 to \< 30
3. Subject must give written informed consent

Key Exclusion Criteria:

1. Subject has a history of malignancy. However, a subject with a history of excised or treated basal cell carcinoma, cervical carcinoma in-situ, or less than or equal to 2 squamous cell carcinomas is eligible to participate in this study.
2. Subject has a history of clinically significant (as determined by the Investigator) cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, and/or other major disease.
3. Subjects with chronic stable diseases including migraines, hypertension, hyperthyroid disorder, hypothyroid disorder, gastroesophageal reflux disease, or mild depression/anxiety will be excluded unless the investigator does not have safety or compliance concerns at study entry.
4. Subject has a history of opportunistic infection (e.g. invasive candidiasis or pneumocystis pneumonia).
5. Subject has had a serious local infection (e.g., cellulitis, abscess) or systemic infection (e.g., septicemia) within the 3 months prior to screening.
6. Subject has a history of severe allergic or anaphylactic reactions.
7. Subject had surgery within the previous 3 months (other than minor cosmetic surgery or minor dental procedures).
8. Subject had a fever (body temperature \> 38°C) or symptomatic viral or bacterial infection within 2 weeks prior to dosing.
9. Subject has a positive Tuberculin skin test (Mantoux)
10. Subject has a history of hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV), or human immunodeficiency virus (HIV).
11. Subject has a recent or clinically significant history of drug or alcohol abuse, or tests positive in a urine screen for alcohol or drugs of abuse.
12. Subject consumed any alcohol within 48 hours prior to dosing.
13. Subject has donated or lost ≥ 499 mL of whole blood within 56 days prior to study drug administration.
14. Subject has taken any hormone replacement therapy within 3 months prior to study enrollment, or plans to begin hormone replacement therapy at any time during the study.
Platelet Function in Patients Undergoing PCI

The purpose of this study is to examine PLT function in PCI patients.


Eligibility Criteria:
Inclusion Criteria:

* All consented patients undergoing PCI

Exclusion Criteria:

* Unable to consent
Statin Therapy in Asymptomatic Aortic Stenosis

There is evidence that the degenerative changes leading to aortic stenosis are caused by a chronic inflammatory process. Furthermore the development of aortic stenosis is partially dependent on typical cardiovascular risk factors. An inflammatory process as well as those risk factors are amenable for medical therapy. As such the use of statins (HMG CoA reductase inhibitors) would be an appealing concept to reduce both those risks for development of aortic stenosis. Aim of this study is to evaluate the usefulness of statin therapy on the progression of aortic stenosis.

This study will be a prospective, double-blind, placebo-controlled, two-armed clinical trial trial to test the influence of statin therapy on the progression of calcified aortic stenosis in patients with asymptomatic mild to moderate aortic stenosis. After completion of all baseline investigations patients will be randomly assigned to the verum group (fluvastatin group) or to the control group (placebo group). Patients in the verum group will receive fluvastatin in a starting dose of 40 mg per day. The dose should be increased up to 80 mg per day. The treatment should be continued until the study end (24 months). Follow up investigations will be performed after 6, 12, and 18 months. After 24 months the final investigations will be performed.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 21 years
2. Mild to moderate aortic stenosis
3. No symptoms caused by aortic stenosis
4. Written informed consent to participate in the study
5. Aortic valve leaflet thickening with reduced systolic opening
6. Reduced aortic valve area \> 0,8 cm2 and \< 1,5 cm2
7. Maximum aortic jet velocity at rest \> 2,5 m/s

Exclusion Criteria:

1. Symptoms caused by aortic stenosis
2. Aortic valve area \< 0,7 cm2
3. Severe aortic regurgitation
4. Reduced left ventricular ejection fraction (\< 50%)
5. Any valve disease with indication for surgery
6. Coronary artery disease
7. Therapy refractory arterial hypertension
8. Comorbid noncardiac diseases or other reasons which make a regular follow-up impossible
9. Other indication for treatment with statins
10. Women of childbearing potential not using the contraception method(s) specified in this study (specify), as well as women who are breastfeeding
11. Known sensitivity to study drug(s) or class of study drug(s)
12. Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study (specify as required)
13. Use of any other investigational agent in the last 30 days
Efficacy Study of Combined Prasugrel and Bivalirudin Versus Clopidogrel and Heparin in Myocardial Infarction

Randomized comparison of two different anticoagulation strategies: prasugrel plus bivalirudin versus clopidogrel plus heparin in patients with acute myocardial infarction undergoing emergency catheterization and coronary intervention.

Primary percutaneous coronary intervention (PPCI) is the preferred reperfusion strategy for patients with acute ST-segment elevation myocardial infarction (STEMI). Additional anticoagulation therapy prior or during intervention plays an important role in the short- and long-term outcomes after PPCI. Two separate studies have shown significant benefit against conventional therapy based on clopidogrel and heparin for two recently approved drugs: the direct thrombin inhibitor bivalirudin and the thienopyridine prasugrel. In the HORIZONS-AMI trial, bivalirudin after pretreatment with clopidogrel resulted in improved net clinical outcomes. However, during the first 24 hours after PPCI an increase in the stent thrombosis rate was observed with bivalirudin therapy. Prasugrel has been shown to be superior to clopidogrel in patients with acute coronary syndromes undergoing PCI. The benefit in reduction of ischemic complication was even greater in the subset of patients with STEMI without any increase in the bleeding risk and with a significant reduction in the stent thrombosis rate. Expectedly, the synergic actions of prasugrel and bivalirudin may maximize the benefit of antithrombotic therapy for STEMI patients undergoing PPCI.

Eligibility Criteria:
Inclusion Criteria:

1. Patients presenting within 24 hours from the onset of symptoms with STEMI
2. Informed, written consent
3. In women with childbearing potential a pregnancy test is obligatory.

Exclusion Criteria:

1. Age \< 18 years
2. Cardiogenic shock
3. Active bleeding; bleeding diathesis; coagulopathy
4. History of gastrointestinal or genitourinary bleeding \<2 months
5. Refusal to receive blood transfusion
6. Major surgery in the last 6 weeks
7. History of intracranial bleeding or structural abnormalities
8. Suspected aortic dissection
9. Heparin-induced thrombocytopenia
10. Any previous stroke
11. Prior administration of thrombolytics, bivalirudin, low-molecular weight heparin or fondaparinux for the index MI
12. Known relevant hematological deviations: Hb \<100g/l, Thromb. \<100x10\^9/l
13. Use of coumadin derivatives within the last 7 days
14. Chronic therapy with nonsteroidal anti-inflammatory drugs (except aspirin), COX-2 inhibitors, prasugrel
15. Known malignancies or other comorbid conditions with life expectancy \<1 year
16. Known severe liver disease, severe renal failure
17. Known allergy to the study medications
18. Previous enrollment in this trial
19. Pregnancy
Effective Fraction of Inspired Oxygen With Nasal Cannula in Premature Infants

The objective of this study is to determine the multifactorial relationship between the effective fraction of inspired oxygen (Effective-FiO2) and the FiO2 in the gas delivered by the nasal cannula (NC-FiO2), NC flow rate, spontaneous minute ventilation and other patient characteristics in premature infants who receive supplemental oxygen via nasal cannula (NC).

During routine nasal cannula (NC) use in the newborn ICU, the actual fraction of oxygen inspired by the infant, i.e. the effective FiO2 (Effective-FiO2) that reaches the infant's airways, cannot be easily determined. The effective FiO2 during NC use is generally lower than the FiO2 in the gas delivered by NC at the infant's nose due to dilution with ambient gas entrained by the infants during spontaneous inspiration. The factors influencing effective FiO2 include the set FiO2 of the gas delivered by NC (NC-FiO2), the NC-flow rate, and the entrainment of ambient gas by the infant during each spontaneous inspiration. The individual contribution of each of these factors to the variability in effective-FiO2 in extreme premature infants has not been systematically evaluated.

The objective of this study is to determine the multifactorial relationship between the effective fraction of inspired oxygen (Effective-FiO2) and the FiO2 in the gas delivered by the nasal cannula (NC-FiO2), NC flow rate, spontaneous minute ventilation and other patient characteristics in premature infants who receive supplemental oxygen via nasal cannula (NC).

Eligibility Criteria:
Inclusion Criteria:

* Premature infants born between 23 and 30 weeks of gestational age
* Receiving supplemental oxygen via nasal cannula
* Parental informed consent

Exclusion Criteria:

* Major congenital anomalies
* Clinically unstable
To Explore the Pharmacokinetics and Relative Bioavailability of Sulfatinib Capsules in Two Different Manufacturers

This is a single-center, randomized, open, single-dose, three-cycle cross-design study, which will be only enrolled Chinese male healthy volunteers.

27-30 Chinese male healthy volunteers will be enrolled to assess the pharmacokinetic profile and relative bioavailability of 300 mg (50 mg x 6) Sulfatinib capsules of single dose orally in two different manufacturers after breakfast. All subjects are required to collect PK blood samples before and after administration at the following time points: within 1 hour before administration, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 12, 24, 36, 48, 72, 96 hours after administration (16 times point), each collection of venous blood is 2mL.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects must be voluntary and sign an informed consent form and agree to comply with the requirements of the protocol；
2. Age of 18-40 (inclusive), male healthy volunteers；
3. Medical history, physical examination, 12-lead ECG and laboratory tests at screening judged as normal or abnormal but not clinically significant by investigators;
4. Medical history, physical examination, 12-lead ECG and laboratory tests at screening judged as normal or abnormal but not clinically significant by investigators;
5. Men whose partners are women of childbearing potential are required to use adequate contraceptive methods during participation in this study；

Exclusion Criteria:

1. Any clinically significant disease or condition includes but not limited to metabolism/endocrine, liver, kidney, blood, lung, immune, cardiovascular, gastrointestinal, genito-urinary, nervous, or mental illness that judged by the investigator within 3 months before screening;
2. Previous gastrointestinal surgery, kidney surgery, cholecystectomy and surgery history may affect the absorption or excretion of drugs;
3. Hypertension: systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg;
4. Hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV Ab) test positive, HIV or treponema pallidum antibodies test positive;
5. Any drugs that may change the liver and kidney clearance;
6. Take any prescription drug (including Chinese herbal medicine) within 14 days before dosing; or use any over-the-counter drugs (including but not limited to vitamins, prophylaxis, plant health products) within 7 days before dosing;
7. Clinical trials of other medications before screening, less than a 5-fold half-life or 28 days from the time of the last other study drug, whichever is longer;
8. Any history of clinically serious disease or condition that the investigator believes may affect the outcome of this study.
Asymptomatic Narrow Angles - Laser Iridotomy Study; Multicentric RCT

This is a multicentric, randomised, controlled study comparing Laser Iridotomy (LI) to no treatment in subjects with asymptomatic narrow angles (ANA).One eye of each subject with ANA will be randomised to undergo LI and the other eye will be left alone and will serve as an internal control. Subjects are proposed to be followed up once a year for 5 years.

Objective: This study will compare LI versus no treatment in subjects with asymptomatic narrow angles, the anatomical trait that predisposes to primary angle closure glaucoma (PACG), in order to assess the effectiveness of prophylactic treatment in the prevention of blindness due to PACG.

Eligibility: 1. Bilateral Narrow angles; 2. Age 50 years and above; 3. Informed consent obtained prior to or at baseline visit.

Trial Design: Subjects with asymptomatic ANA undergoes randomisation after comprehensive ocular exam followed by randomisation to LI in one eye and no treatment in the other eye. Follow up is done for 5 years with yearly examination.

Eligibility Criteria:
Inclusion Criteria:

1. Bilateral Narrow angles
2. Age 50 years and above
3. Informed consent obtained prior to or at baseline visit

Exclusion Criteria:

1. Presence of PAS
2. IOP \> 21 mm Hg
3. Glaucomatous optic neuropathy and/or CDR \> 0.7
4. Secondary angle closure such as uveitis, neovascularisation etc.
5. Prior intraocular surgery or penetrating eye injury
6. Corneal disorders such as corneal endothelial dystrophy except mild corneal guttae
7. Evidence of prior acute angle closure event
8. High risk of acute angle closure.
9. Significant cataract and visual acuity less than 20/40
10. Constant use of contact lens for refractive correction
11. Chronic use of topical or systemic steroids
12. Established retinopathies on ocular treatments (e.g. Diabetic)
13. Any other disease which is likely to cause field loss in next 3 years
14. Severe health problems decreasing life expectancy to less than one year.
Etanercept for Non-Infectious Lung Injury Following Bone Marrow Transplantation

The purpose of this study is to determine the effects of etanercept, and define the toxicity, when administered to patients with acute non-infectious lung injury (idiopathic pneumonia syndrome, IPS) and with subacute pulmonary dysfunction after allogeneic stem cell transplantation.

Over the last 2 decades, allogeneic bone marrow transplantation (BMT) has emerged as an important treatment option for a number of malignant and non-malignant disorders. Unfortunately, pulmonary dysfunction remains a frequent and severe complication of allogeneic BMT. One of the main chemicals felt to cause lung damage is Tumor Necrosis Factor (TNF). Etanercept is an experimental drug that attempts to block TNF lung damage. Patients will undergo blood tests, x-rays, and a bronchoscopy with broncho-alveolar lavage prior to treatment with etanercept to check for infection. If no infection is evident after 24 hours, the etanercept will be started and administered twice weekly for 4 weeks by subcutaneous injection. There will be weekly blood tests and bronchoscopy after the last drug dose.

Eligibility Criteria:
Inclusion criteria:

* Diagnosis of acute idiopathic pneumonia syndrome (IPS) or sub-acute lung injury
* At least 1 year of age for IPS stratum
* At least 6 years of age for sub-acute lung injury stratum and able to perform formal pulmonary function testing
* At least 14 days since prior treatment with an investigational drug for graft-versus-host disease
* Previously treated with allogeneic stem cell or bone marrow transplantation for primary disease

Exclusion criteria:

* Documented evidence of active systemic or pulmonary infection
* Cardiogenic failure as cause of pulmonary dysfunction
* Known hypersensitivity to etanercept
* Currently receiving dialysis
* Currently receiving inotropic medications except dopamine
* Pregnant or nursing
A Study of a Low-Carbohydrate Diet to Improve Maternal Health After Childbirth

The study is evaluating the effects of a standard diet to a low carbohydrate diet in obese women after having a baby. The purpose of the study is to determine if a low carbohydrate diet is associated with improvement in insulin sensitivity in postpartum women.


Eligibility Criteria:
Inclusion Criteria:

* Delivery at University of Texas Medical Branch
* Body max index greater than or equal to 30 kilograms/meters squared at the final prenatal visit prior to delivery.
* Singleton gestation.
* Accessibility to the internet.
* Basic understanding and comprehension of the English language to be assessed by study personnel at the time of recruitment.

Exclusion Criteria:

* Diabetes mellitus on medication.
* Serious medical condition, such as heart failure, kidney failure, or severe asthma, as determined by the principle investigator.
* Planned pregnancy during study period.
* Enrolled in another trial that may affect outcome.
* Subject unlikely to be followed up after delivery.
Bromelain and Escin in the Reduction of Postoperative Sequelae in Periodontal and Implant Surgery

A randomized clinical trial will be performed in parallel, placebo controlled, triple-blind to evaluate the effectiveness of the association Bromelina and Horse-chestnut (titrated in escin) (Noflogo®, Mavenpharma s.r.l., Rome, Italy) in the management of post trauma-surgery following surgery periodontal and implant surgery.

At least 50 volunteers between the ages of 18 and 50, will be enlisted, with the need to perform one of the interventions described above and that fall within the criteria of inclusion.

The study will be carried out in accordance with the Helsinki Declaration on In Vivo Studies and will be initiated with the approval of the Internal Review Board of the University of L'Aquila.

The protocol follows the guidelines of the CONSORT Statement for parallel studies and will be recorded on the data base clinicaltrials.gov.

Eligibility Criteria:
Inclusion Criteria:

* No signs of gingival inflammation;
* FMBS and FMPS ≤ 20% after non-surgical causal therapy (Only for patients undergoing periodontal surgery)
* Smokers have to indicate how many cigarettes they smoke and how long have they been smoking

Exclusion Criteria:

* Gingival inflammation
* Positive anamensis for relevant systemic pathologies (renal, cardiovascular, hepatic, infectious, neoplastic and diabetological)
* Treatment with anti-inflammatory and/or antibiotics in the two weeks preceding the start of the trial
* History of allergy to one or more components of the medication to be tested
* Pregnant women
Pruritus in Patients With Chronic Kidney Disease

We believe that knowing characteristics of uremic pruritus is the foundation to investigate its pathophysiology and offer better skin care for patients with chronic kidney disease. We therefore conducted this cross-sectional study to evaluate the characteristics of uraemic pruritus.


Eligibility Criteria:
Inclusion Criteria:

* Adults older than 20 years old, with CKD stage 3 to 5D, with symptoms of pruritus.

Exclusion Criteria:

* Patients who refused to answer the questionnaire or unable to understand the contents of the questionnaire.
Composite Restorations Performed by Placing Polyethylene Fiber

This study aimed to evaluate the 12-month clinical performance of direct composite restorations by placing polyethylene fibers in different directions in endodontically treated posterior teeth. In this clinical study, Clearfil SE Bond (Kuraray/Japan) adhesive system, G-aenial Universal Injectable (GC/Tokyo, Japan), G-aenial A'chord (GC/Tokyo, Japan) composites, and polyethylene fiber (Ribbond, USA) were used. In the restoration of the teeth included in the study, polyethylene fiber was placed in different directions according to the amount of remaining tooth tissue and cavity preparation. The restorations were divided into three groups according to the direction of fiber placement ('O' shape, mesiodistal I shape, buccolingual I shape) (n=12). Restorations were evaluated according to modified USPHS criteria in 1st week and 6th months from the placement date. The Chi-square test was used for statistical analysis of the difference between the groups, and the Cochran Q test was used for the significance of the difference between time-dependent changes within each group (p\<0.05).


Eligibility Criteria:
Inclusion Criteria:

A patient presenting with;

1. over 18 years of age
2. a normal periodontal status and good general health
3. endodontically treated premolar and molar teeth
4. teeth in contact with the opposing tooth and subjected to normal occlusal forces
5. attend follow-up appointments

Exclusion Criteria:

1. poor oral hygiene status
2. those with severe or chronic periodontitis
3. absence of adjacent and antagonist teeth
4. potential behavioral problems (e.g. bruxism)
5. allergy to any product used in the study
6. systemically unhealthy
7. pregnant and lactating women
Comparison of 6-fluoro-[18F]-L-dihydroxyphenylalanine (18F-DOPA) Positron Emission Tomography (PET) and Multiparametric Resonance Magnetic Imagery (RMI) in Initial Exploration of Glial Tumors

For patient having a brain tumor, RMI is the standard exam for tumor characterization and determines initial surgery.

The aim of this study is to assess if PET could provide additional information that could have an impact on surgery (indication and planification)


Eligibility Criteria:
Inclusion Criteria:

* Suspected glial resectable tumor
* Free and informed consent
* Affiliated to French social security

Exclusion Criteria:

* Suspected high grade glioma
* Surgical emergency
* Pregnant or breastfeeding woman
* Patient deprived of their liberty or under guardianship
* Patient not able to follow study medical monitoring for geographical, social or psychological reasons
* Treated with carbidopa, catechol-O-methyl transferase inhibitor, haloperidol, reserpine within 2 weeks before PET imagery