cyrilzakka/clinical-trials huggingface dataset:
Clinical Evaluation on the Longevity of Glass Ceramic Based Single Tooth Restorations

This retrospective study investigates the longevity of lithium disilicate based glass-ceramic single tooth restorations placed with IPS e.max CAD and IPS e.max Press after a wearing period of more than 15 years. The primary objective is to assess the survival rate of single tooth restorations with IPS e.max CAD and IPS e.max Press after a wearing period of at least 15 years. The secondary objectives are to assess the quality of the single tooth restorations in regard of aesthetic, functional and biological properties.


Eligibility Criteria:
Inclusion Criteria:

* Age: \> 18 years
* Informed consent signed and understood by the subject
* Received indirect single tooth restoration (inlay, onlay, veneer or crown) within the internal clinic of Ivoclar Vivadent AG between 2006 and 2010
* Single tooth restoration was done with IPS e.max CAD or IPS e.max Press
* Able to visit the internal clinic of Ivoclar Vivadent AG in Schaan, FL.

Exclusion Criteria:

* Health status (physical and mental) does not allow participation
Characterization of Familial Myopathy and Paget Disease of Bone

The researcher wants to explore the genetic causes of muscle disease. The researcher is particularly interested in muscle disorders that occur in combination with diseases of bone that appear to be passed on from generation to generation.

Diffuse Optical Spectroscopy will measure the concentrations of blood, water, and lipids (fats, for example) in your tissues. This device essentially measures the color of tissues in order to determine tissue physiology (its physical and chemical processes).

Diffuse Optical Spectroscopy, the technique is fast and painless and was developed at the University of California, Irvine. The Diffuse Optical Spectroscopy instrument is actively involved in research studies, but is not yet a part of routine clinical practice. The result of this study will aid similar research projects that seek to improve our understanding of how tissues work and how alterations in metabolism affect long-term health.

TheDiffuse Optical Spectroscopy measurement consists of placing a probe onto the surface of your body (calf, bicep, or head). This probe will be secured by either gentle hand pressure or fastened to your skin using clinically-approved wraps such as Coban/wrap bandages or medical adhesive tape and medical glues. Several dots will be made on your skin outlining the probe with a surgical felt tip marker. This is so we would be able to put the probe again on the same spot in case we needed to interrupt the measurement. The probe looks like a bar code scanner in a supermarket and it shines infrared light on your skin. There is no radiation involved with this light. In some cases where light signals are low, the optical detector will be placed directly onto your skin (but contained within an electronically shielded casing, and placed inside another plastic casing). (not offered during pregnancy).

Eligibility Criteria:
Inclusion Criteria: Male or Female age 18 and older

* diagnose of Muscle or bone disorders
* with a combination of medical problems including muscle and bone disease and their family members.

Exclusion Criteria:

* under 18 year of age
* unrelated diagnosis
Study the Role of Genetic Variation in the Determining Lipid Profile Response to Dietary Change

The purpose of this study is to determine whether plasma lipoproteins and lipid responsiveness to a dietary modification is influenced by CETP gene polymorphism.


Eligibility Criteria:
Inclusion Criteria:

* Healthy Volunteers

Exclusion Criteria:

* History of any cardiovascular diseases
* type 1 diabetes
* type 2 diabetes
* use of lipid-lowering medications
* hypertension
* pregnancy
* Current intake of vitamins and supplements
* History of endocrin disorder
Introduction of Microsystems in a Level 3 Neonatal Intensive Care Unit

The advancement in life-saving technologies and clinical expertise in the care of extremely premature infants, have resulted in the development of large neonatal intensive care units (NICU). It has been suggested that reconstruction of megaunits of neonatal intensive care to smaller care units with specific patient population and clinical team providers will be essential to maintain optimal teamwork, quality of care and patient outcome.

Despite the growing knowledge around the need for reconstruction of large NICUs to smaller units of care, there is no evidence regarding the safety and efficacy of microsystem model of care on the key aspects of health care. At the McMaster Children's Hospital (MCH), we planned a change from standard model of care to the microsystem model of care and therefore we aimed to prospectively assess the effect of this organizational change on the variable aspects of health care.

A working group met weekly to formulate the implementation planning, to review the adaptation and adjustment process and to ascertain the quality of implementation following the initiation of the microsystem model.

The study was retrospectively registered.


Eligibility Criteria:
Inclusion criteria:

* All preterm and term infants admitted to McMaster Children's Hospital NICU

Exclusion criteria:

* no exclusion criteria
Cardiac Magnetic Resonance Imaging and Pulmonary Perfusion

Pulmonary hypertension is a rare severe disease leading to cardiac insufficiency. Treatment depends on the severity of the disease.

This study evaluates cardiac MRI for the assessment of pulmonary hypertension severity and identification of parameters useful for the follow-up in order to adapt the medical treatment to status of the patient.

Evaluate if cardiac MRI can obviate right cardiac catheterization in the follow-up.

Thirty patients will be enrolled and followed for 1 year after their inclusion.

Cardiac MRI will be performed at inclusion and at 3 months and 12 months. At the same periods, echocardiography and right heart catheterization will be performed too.

Morphological and functional parameters will be studied with MRI and correlated to invasive parameters and echocardiography too.

Morphological parameters are: volumes, cardiac cavities areas and ratios and position of the interventricular septum. Functional parameters are: ejection fractions of right and left cavities, flow in pulmonary artery, across mitral and tricuspid valves, temporal measurements in the pulmonary artery and auriculoventricular valves.

The invasive measurements are considered as the gold standard for this study. The classification of the severity is defined according to the parameters from right cardiac catheterization (4 grades with severity increasing between 1 and 4).

Eligibility Criteria:
Inclusion Criteria:

* Adults patients with pulmonary hypertension without specific treatment at inclusion
* Etiologies include chronic embolic disease, systemic fibrosis, Gougerot Sjogren, drug induced hypertension, primary hypertension.
* informed consent
* affiliated to medical insurance.

Exclusion Criteria:

* Left cardiac disease responsible for pulmonary hypertension, congenital cardiopathies
* Pulmonary functional tests with important impairment (decrease in TPCmore than 30%, decrease In VEMS more than 30%
* Child
* pregnancy
* contraindications to MRI
* without informed consent
* without insurance
Association of Plasma Biomarkers for Neurological Injury and Postoperative Delirium After Cardiac Surgery

Delirium is one of the most common complications after cardiac surgeries, incidence of which is 20\~70%. Causes and pathophysiology of delirium has not been elucidated yet, however, inflammatory response of the nervous system, imbalance of neurotransmitters and ischemia-reperfusion injury of brain tissue are thought to play a big role.

'Neurofilament light (Nfl)' and 'Tau' are proteins that comprise neurons, which are released into blood during acute brain injury. Increased serum concentrations of these markers are acknowledged to be associated with worse clinical outcomes in patients with acute brain injury. These proteins are also closely linked to degenerative changes in the nervous system and cognitive decline in Alzheimer's disease. Therefore, the increase in blood levels of 'Nfl' and 'Tau' may be related to the development of delirium.

The aim of this study is to investigate the association between 'Nfl' and 'Tau', serum markers of damage of the nervous system, and the development of delirium after cardiac surgery.

1. Assessment of cognitive function and delirium Before the day before surgery, K-MMSE (Korean version of Mini-Mental State Exam) is conducted to check the subjects' baseline cognitive function.

   From the postoperative day 0 to 7, CAM-ICU (Confusion Assessment Method for the Intensive Care Unit) for mechanically ventilated patients, or 3D-CAM (3-minute diagnostic assessment for delirium using the Confusion Assessment Method) for extubated patients is performed twice a day to assess whether delirium occurs. Records of the nurses are also checked.
2. Measurement of the serum levels of Nfl and Tau Serum concentrations of Nfl and Tau are measured after anesthetic induction, and at postoperative 6 hours

Eligibility Criteria:
Inclusion Criteria:

* 1. Patients undergoing valvular heart surgery (\>65 years old)

Exclusion Criteria:

* 1. Emergency operation
* 2. Patients with drug or alcohol abuse
* 3. Patients with major depressive disorder, major neurocognitive disorder or schizophrenia
* 4. Patients with schizophrenia
* 5. Patients who are not able to communicate verbally
Effect Of Nicotine on Neurocognitive Performance of Cigarette Smokers

This research project addresses the hypothesis that a neurocognitive profile characterized by impairment of response inhibition and sustained attention may be a risk factor for smoking initiation and nicotine dependence among young women. Nicotine has short- term, facilitating effects on attention and response inhibition. Therefore, individuals who are impaired on cognitive functions such as these and initiate cigarette smoking may be more likely to maintain the habit and develop nicotine dependence. The research protocol specifically tests whether administration of nicotine to non-abstinent, regular cigarette smokers improves cognitive function in those domains where the participants had previously been shown to manifest performance deficits


Eligibility Criteria:
Inclusion Criteria:

* Reported smoking cigarettes on a daily basis at the time of the original study and continue to smoke currently
* Manifested poor performance on the MFFT (The neurocognitive test that yielded differences between smokers and non-smokers)
* Competent and willing to give written informed consent

Exclusion Criteria:

* Pregnancy, breast-feeding, non-use of contraception such that the possibility of pregnancy cannot be excluded
* Intake of any medication that may potentially interact with nicotine.
* Any current or past medical condition that represents a contra-indication to nicotine administration.
[18F]FLOR (FC303) PET/CT Imaging in Patients With Prostate Cancer

The study is an open label, single-arm study designed to evaluate the safety and diagnostic performance of \[18F\]FLOR (FC303) PET/CT imaging to determine the presence or absence of metastatic prostate cancer. .

This research is being done to determine whether the radioactive compound called \[18F\]FLOR (FC303) is safe and well-tolerated in patients with metastatic prostate cancer.

Participants in this study will have tests, exams and procedures that are for study purposes. Participants will be in this study up to one month which will include up to three clinic visits.

Eligible patients diagnosed with metastatic prostate cancer will undergo a \[18F\]FLOR (FC303) PET-CT scan. This is the imaging procedure to assess where \[18F\]FLOR (FC303) has accumulated in the body.

Eligibility Criteria:
Inclusion Criteria:

* Males ≥18 years of age.
* Subjects provide signed informed consent and confirm that they are able and willing to comply with all protocol requirements.
* Histologically confirmed adenocarcinoma of the prostate.
* Radiologic evidence of local recurrence or new or progressive metastatic disease demonstrated on anatomical imaging (CT, or MRI), or whole-body bone scan within 4 weeks of Day 1.
* At least 2 weeks must have elapsed between last anti-cancer treatment administration and the imaging day. Imaging day will be scheduled before initiation of new systemic therapy for recurrent and/or progressive metastatic disease
* Screening clinical laboratory values within normal limits or judged not clinically significant by the investigator.

Exclusion Criteria:

* Subjects administered any radioisotope within five physical half-lives prior to study drug injection.
* Subjects with any medical condition or other circumstances that, in the opinion of the investigator, compromise obtaining reliable data, achieving study objectives, or completion.
Double-lumen Tube Intubation Technique to Reduce Laryngeal Injuries

The purpose of this study is to devise the method to reduce laryngeal injuries during double-lumen tube intubation.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing thoracic surgery that require the placement of left-sided double-lumen tubes

Exclusion Criteria:

* Preoperative hoarseness or sore throat
* History of upper airway diseases
* Anticipated difficult airway
* Operation time longer than 6 hours
A Phase 2b Evaluation of Daclatasvir/Sofosbuvir in Non-Cirrhotic Treatment Naive Subjects With Genotype 1, 2, 3 and 4 Chronic Hepatitis C Virus Coinfected With Human Immunodeficiency Virus (HIV-1)

The purpose of the study is to determine if combination therapy with daclatasvir (DCV) and sofosbuvir (SOF) for 8 weeks is safe and effective in patients who have never been treated previously without liver cirrhosis who are chronically infected with hepatitis C virus (HCV)/HIV-1 Coinfection genotype (GT) 1, 2, 3, 4 patients.


Eligibility Criteria:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* HCV RNA \< 2000000 IU/mL
* Never taken medication for HCV
* No Liver Cirrhosis
* No advanced fibrosis
* Body mass index(BMI) 18-40 kg/m\^2
* Genotype 1-4

Exclusion Criteria:

* Infection with HCV other than GT-1, 2, 3 or GT-4 or subjects with mixed infections of any genotype
* Evidence of decompensated liver
* Subjects Infected with HIV 2
* Hepatitis B virus (HBV) coinfection
* Liver Cirrhosis
* Advanced fibrosis (F3-F4)
Target Site Pharmacokinetics of Doripenem at Steady State in Intubated Intensive Care Patients

The investigators will measure the pharmacokinetics of doripenem in skeletal muscle, subcutaneous adipose tissue, bronchoalveolar lavage and plasma of intubated intensive care patients.

Methods: microdialysis, blood sampling, bronchoalveolar lavage

Eligibility Criteria:
Inclusion Criteria:

* endotracheal intubation; pneumonia or complicated abdominal infection or complicated urinary tract infection

Exclusion Criteria:

* allergy to doripenem, hemodialysis
The Effect of Intraoperative Labetalol on Time to Discharge

Patients coming for surgery often receive opioid medications, like fentanyl, to treat pain. Opioids however have many unpleasant side effects including nausea and vomiting, itching, sedation, and decreased breathing. During laparoscopic surgery increases in heart and blood pressure are often attributed to pain. It has been shown that by treating these changes with medications such as esmolol, instead of opioids, side effects and time to discharge from hospital can be reduced. Labetalol is a drug that is similar to esmolol but may have advantages over it. It is more effective at controlling both heart rate and blood pressure and it is easier and less costly to use. This study is investigating labetalol in patients having laparoscopic gallbladder surgery and comparing it to esmolol and fentanyl. Patients will be treated with one of these drugs during surgery to control heart rate and blood pressure and the effects on time to discharge, pain scores, frequency of side effects, and narcotic requirements will be observed in the recovery room. It is thought that labetalol will be shown to be as effective as esmolol and that both drugs that minimize fentanyl will show reduced time to discharge, fewer side effects, and effective treatment of heart rate and blood pressure.


Eligibility Criteria:
Inclusion Criteria:

* scheduled to undergo elective ambulatory laparoscopic cholecystectomy under general anesthesia
* American Society of Anesthesiologist's Status ASA) 1-3
* able to understand and sign informed consent

Exclusion Criteria:

* known allergy to any of the study medications including beta blockers, fentanyl, acetaminophen, non-steroidal anti-inflammatories or local anesthetics
* chronic use of beta-adrenergic receptor antagonists or opioids
* conversion to open cholecystectomy
* History of renal, hepatic or cardiac failure, reactive airway disease
* Medical history that in the investigator's judgement would interfere with the protocol or assessments
* Unable to understand pain assessment
* Failure to give informed consent
* pregnant or breastfeeding
Cohort of Chronic Pain Patients

Chronic pain affects approximately 20% of adults, 50% of the elderly population and over 1.5 billion people worldwide. Societal and economic issues are also crucial, as 60% of people with pain are less able or unable to work and 20% say they have lost their jobs because of pain. The overall cost of chronic pain is estimated at around 300 billion euros in the EU. Unfortunately, current treatments for chronic pain have limited effectiveness and important adverse effects. Pain clinics, which support the most complex and refractory cases of chronic pain, as well as general practitioners and patients expect improvements, both in terms of therapeutic efficacy and organization of care.

In order to allow the characterization and a personalized follow-up of chronic pain patients, we have created e-DOL, a smartphone application for patients and a web platform for healthcare professionals in pain clinics. The purpose of this study is to create an e-cohort for the research, and characterization and follow-up of chronic pain patients.

This first French e-cohort of chronic pain patients will allow real-life follow-up in order to generate big data including various information on chronic pain, associated-comorbidities, pain impacts on sleep, activity and psycho-emotional parameters, sociodemographic characteristics and pain treatments.

These data will be collected with he eDOL tool (smartphone application for patients and web platform for caregivers in pain clinics), integrating numerous repeatable questionnaires, weekly barometers, a therapeutic education module and a conversational agent (chat bot).

All of these data will also be linked with French health insurance care data in order to get an overview of comorbidities and patient care consumption in a medico-economic approach.

The study will include 20 pain clinics and a minimum of 5000 patients followed for 24 months.

Eligibility Criteria:
Inclusion Criteria:

* All patients with chronic pain
* patients equipped and regular users of a smartphone
* Non-opposition to participation in the study

Exclusion Criteria:

* Patient unable to understand or answer questionnaires
Clopidogrel and Aspirin Interaction Study-2

Clopidogrel and aspirin are commonly used in combination to prevent heart attacks and to prevent blockage of stents. Both clopidogrel and aspirin work by preventing platelets (sticky cells that circulate in the blood) from forming blood clots in the arteries supplying oxygen to the heart and in stents. The investigators hypothesize that aspirin 325mg compared with aspirin 81 mg will increase blood levels of the active metabolite of clopidogrel in patients with a history of coronary artery disease who receive a 600mg loading dose of clopidogrel.

Eligible patients will be randomized to receive clopidogrel 600mg + aspirin 325mg (Group A) or clopidogrel 600mg + aspirin 81mg (Group B). Patients will be fasted for at least 8 hours prior to study drug administration. Blood samples will be collected at 1 hour after study drug administration for measurement of clopidogrel active metabolite levels and genotyping.

Eligibility Criteria:
Inclusion Criteria:

* Stable patients \>1 month post ACS (including ST elevated myocardial infarction, non-ST elevated myocardial infarction or unstable angina) or stent
* Receiving regular ASA (81mg/d) and clopidogrel (75mg/d) for at least 1 week
* Written informed consent

Exclusion Criteria:

* Age \< 18 years
* Liver disease with ALT or bilirubin \>2x upper limits of normal (ULN)\*
* Renal impairment with creatinine clearance \<30 ml/min\*
* Deemed to be at high risk of bleeding (e.g., recent bleeding, platelet count\<100x109/L or hemoglobin \<100g/L)\*
* Anticoagulant or NSAID therapy within the last 5 days
* Antiplatelet agent other than aspirin and clopidogrel within the last 10 days
* Uncontrolled hypertension (\>=180/110mmHg)

  * within 3 months of planned randomization
A Study to Explore Efficacy and Safety of ASP015K in Subjects With Moderate to Severe Psoriasis

The purpose of this study is to explore the efficacy and safety of multiple, escalating doses of ASP015K when compared to placebo in subjects with moderate to severe plaque psoriasis.

Following completion of at least 1 week of study drug for all subjects in group 1, the Sponsor will review the safety information of these subjects prior to enrolling off-treatment subjects into the next dose group. Dose escalation will continue in this manner (unless stopping criteria are met) until all groups have completed the study.

Eligibility Criteria:
Inclusion Criteria:

* Subject has moderate to severe plaque psoriasis for 6 months or longer with at least 10% Body Surface Area (BSA) affected
* Subject must be a candidate for phototherapy and/or systemic therapy

Exclusion Criteria:

* Subject has non-plaque psoriasis or drug-induced psoriasis
* Subject is on systemic psoriasis therapy within 56 days or 5 half-lives, whichever is longer, prior to first dose of study drug
* Subject has a positive TB skin test within 3 months of screening or at screening
* Subject has an abnormal chest x-ray