cyrilzakka/clinical-trials huggingface dataset:
Safety, Efficacy and Pharmacokinetic Study of Dexmedetomidine in Pediatrics Ages ≥28 Weeks to ≤44 Weeks Gestational Age

The purpose of this study is to investigate the safety, efficacy and pharmacokinetics (PK) of dexmedetomidine (DEX) at 3 different dose levels in infants, ages ≥28 weeks to ≤44 weeks gestational age, administered as a loading dose followed by a continuous infusion for a minimum of 6 hours and up to 24 hours in the neonatal intensive care unit (NICU), cardiac intensive care unit (CICU), or pediatric intensive care unit (PICU).


Eligibility Criteria:
Inclusion Criteria:

1. Initially intubated and mechanically ventilated pediatric subjects in an intensive care setting anticipated to require a minimum of 6 hours of continuous IV sedation.
2. The ability to complete all PK sampling blood draws.
3. Age: subjects must fit into 1 of the following age ranges at screening:

   * Preterm neonates ≥28 weeks through \<36 weeks, gestational age; this would constitute treatment Group I.
   * Term neonates born at ≥36 weeks through ≤44 weeks gestational age; this would constitute treatment Group II.
4. Weight: subject's weight at the time of enrollment must be \>1000 g.
5. Subject's parent(s) or legal guardian(s) has/have voluntarily signed and dated the informed consent document approved by the Institutional Review Board (IRB)/Independent Ethics Committee (IEC).

Exclusion Criteria:

1. Neonate subjects with neurological conditions that prohibit an evaluation of sedation such as:

   * Diminished consciousness from increased intracranial pressure.
   * The presence of catastrophic brain injury or other severe mental disorders that would make responses to sedatives unpredictable and/or measurement of the N-PASS unreliable.
   * Subjects with immobility from neuromuscular disease or continuous infusion of neuromuscular blocking (NMB) agents.
2. Subjects with second degree or third degree heart block unless subject has a pacemaker or pacing wires are in situ.
3. Heart rate \<120 bpm prior to the initiation of study drug.
4. Exposure to any investigational drug within 30 days prior to study drug administration.
5. Previous exposure to Dexmedetomidine (DEX) as part of an investigational study.
6. Maternal history of poly-substance drug abuse, based upon the presence of 1) an abnormal urine drug screen for cocaine, opiates and/or benzodiazepines; or 2) Investigator's judgment.
7. At the discretion of the Investigator, subjects in whom the risk of DEX treatment is expected to exceed its benefits.
8. Subjects who have a known allergy or contraindication to fentanyl, morphine, Midazolam, DEX, or other α-2 agonists.
9. Requirement for medications other than DEX, Midazolam, morphine, or fentanyl for sedation and pain control.
10. Screening alanine aminotransferase (ALT) levels \>115 U/L.
An Open-label, Single Center Trial to Assess the Pharmacokinetics, Pharmacodynamics and Safety of Org 36286 (P07004)

The objectives of this study were to study the pharmacokinetics, pharmacodynamics and safety of Org 36286 after a single subcutaneous administration in healthy females.


Eligibility Criteria:
Inclusion Criteria:

* Good physical and mental health;
* Body Mass Index between 18 and 29 kg/m\^2;
* Good venous accessibility;

Exclusion Criteria:

* Clinically relevant abnormal blood chemistry, hematology and/or urinalysis at screening;
* Hypertension (sitting diastolic blood pressure \> 90 mmHg and/or systolic blood pressure \> 150 mmHg);
* Contraindications for the use of oral contraceptives or gonadotropins;
* PAP-smear (= III) according to the Papanicolaou classification;
* History of endocrine abnormalities such as hyperprolactinaemia, polycystic ovary syndrome or any evidence of ovarian dysfunction;
* Primary ovarian failure;
* Ovarian cysts or enlarged ovaries, not related to polycystic ovarian disease;
* Any ovarian and/or abdominal abnormality that would interfere with adequate ultrasound investigation;
* Ovarian surgery;
* Smoking more than 10 cigarettes or equivalents a day;
* History (within 12 months) of alcohol or drugs abuse;
* Blood donation (\> 200 ml) within 90 days prior to screening;
* Administration of investigational drugs within 90 days prior to start Org 36286.
Emergency Structured Clinical Examination Training bOX

This is a pragmatic, randomized, controlled study carried out in the emergency department of Angers University Hospital.

All students on placement over a 10-week period will be able to take part in the study. After a clear explanation to the students during the welcome meeting, followed by the collection of free and informed non-opposition, the students will be assigned according to the "ECOX" or "traditional" approach, depending on the randomization status of the internship period. The inclusion arm will be the same for all students over the placement period.

For the traditional approach (control group), students will participate in the OSCEs of the services scheduled at the end of the internship. Students will use the various revision methods usually offered to them by the faculty or in the emergency department, apart from the "ECOX tool". Revision methods are left to their own discretion. Students will complete the internship without any knowledge of the ECOX tool.

For the ECOX approach, students included in the intervention arm will be invited to use the ECOX tool. They will have the various ECOX grids and a stopwatch at their disposal in the 2 units of the emergency department. They will have around thirty evaluation grids at their disposal. The students will choose the ECOX grid corresponding to their initial situation, based on the nurse's triage of the patient. They must ask the patient's permission to practice with them. They must not look at the ECOX grid. As with the on-duty ECOS, they will have 7 minutes to complete the interview and clinical examination. Once this time has elapsed, they will have to compare their answers with the expectations of the grid. They may also be observed by a co-external study participant, a department intern or a senior staff member who is not involved in the OSCE evaluation. They will act as observers and complete the grid. The students will then be able to propose modifications to the grids. Each completed grid will be returned to a drawer in the cubicle, to assess adherence to the tool and suggestions for grid modifications, as well as any comments.

Students will be able to use them as many times as they like during the course and before the service ECOS.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Medical student in a non-ERASMUS emergency department
* Participating in the service ECOS planned at the end of the internship
* No free and informed consent from the student.

Exclusion Criteria:

* Refusal to participate in the study.
* Student returning to the emergency department and having already participated in the study.
Common Bile Duct Stones - Natural History and Interventions

The aims of this study were to

1. investigate what measures were taken when common bile duct stones (CBDS) were found intraoperatively in Sweden during the period May 2005 to December 2009 by using data from this population-based nationwide registry, and
2. analyze the outcome in terms of complications and success rates of bile duct clearance in relation to various stone sizes and interventions used. In order to further characterize the natural course of CBDS of various sizes, particular interest was focused on patients with positive findings where no peroperative measures to clear the bile ducts were taken or planned postoperatively.


Eligibility Criteria:
Inclusion Criteria:

* common bile duct stones

Exclusion Criteria:

* none
EPIC US Pivotal Study

Multicenter, prospective, pivotal study designed to demonstrate the safety and efficacy of the Lumen Biomedical, Inc. FiberNet® Embolic Protection System as an adjunctive device during carotid artery percutaneous intervention in high surgical risk patients.


Eligibility Criteria:
Inclusion Criteria:

* One or more of the high surgical risk criteria.
* Symptomatic with atherosclerotic stenosis ≥ 50% or asymptomatic with atherosclerotic stenosis ≥ 70% of the carotid artery by NASCET Criteria.

Exclusion Criteria:

* Prior stenting of ipsilateral carotid.
* Planned treatment of contralateral carotid within 30 days.
* Experienced a myocardial infarction within the last 14 days.
* Undergone an angioplasty or PTCA/PTA procedure within the past 48 hours.
* Undergone cardiac surgery within the past 60 days.
* Suffered a stroke within the past 14 days.
* Suffered a transient ischemic neurological attack (TIA) or amaurosis fugax within the past 48 hours.
* Abnormal baseline blood counts; platelets \<50,000 or \>700,000/mm3 or WBC count \< 3 x103/uL.
* Intracranial stenosis that exceeded the severity of an extracranial stenosis.
* Total occlusion of the target vessel.
* Lesion within 2cm of the ostium of the common carotid artery.
* A stenosis that is known to be unsuitable for stenting
* Serial lesions that requires more than one stent to cover entire lesion.
Pharmacodynamic and Pharmacokinetic Variability of a Basal Insulin (0000-168)

The purpose of this study is to evaluate whether the within-subject variation in duration of action and time-action profile of glargine measured by isoglycemic clamp will be below prespecified levels.


Eligibility Criteria:
Inclusion Criteria:

Part 1:

* Patient is a male between 18 to 45 years of age (inclusive) at the prestudy (screening) visit
* Patient has a clinical diagnosis of type 1 diabetes
* Patient must have been treated with insulin since diagnosis and be on a stable dose of insulin
* Patient has a Body Mass Index (BMI) of \<=27 kg/m2 and \>18 kg/m2
* Patient has been a nonsmoker and/or has not used nicotine or nicotine-containing products for at least approximately 6 months

Part 2:

* Subject is a male between 18 to 45 years of age at the prestudy (screening) visit
* Subject has a Body Mass Index (BMI) of \<=25 kg/m\^2
* Subject has been a nonsmoker and/or has not used nicotine or nicotine-containing products for at least approximately 6 months

Exclusion Criteria:

Part 1:

* Patient has a history of stroke, chronic seizures, or major neurological disorder
* Patient has currently active and untreated clinically significant endocrine, cardiovascular, hematological, hepatic, renal, respiratory, or genitourinary abnormalities or diseases
* Patient has a history of hypertension requiring treatment
* Patient has a history of neoplastic disease within the past 5 years
* Patient is currently being treated with, or has a history of treatment with any oral antihyperglycemic agent
* Patient has a history of significant multiple and/or severe allergies

Part 2:

* Subject has a history of stroke, chronic seizures, or major neurological disorder
* Subject has a history of hypertension requiring treatment
* Subject has a history of neoplastic disease within the past 5 years
* Subject has history of diabetes (Type 1, Type 2 or steroid-induced) or family history of diabetes mellitus
* Subject has a history of hypersensitivity to glargine or any of its inactive ingredients
Earlobe Creases Predict Prognosis in Chinese Patients With Acute Myocardial Infarction

To investigate the feasibility of the earlobe crease as an early prognostic predictor for acute myocardial infarction(AMI) in Chinese population.

Primary Objective : 1 year primary composite end point (including the whole death, recurrent myocardial infarction, stroke, target vessel revascularization, stent thrombosis) in AMI patients with different types of earlobe crease.

Secondary objective:

1. The incidence of complications during hospitalization
2. The rate of rehospitalization due to cardiovascular disease
3. The incidence of revascularization at 1 year after AMI

Eligibility Criteria:
Inclusion Criteria:

1. Initial acute myocardial infarction(AMI)
2. Detection of a rise and/or fall of cardiac biomarker values (preferably cardiac troponin (cTn) with at least one value above the 99th percentile upper reference limit (URL)) and with at least one of the following:

   * Symptoms of ischemia
   * Development of pathologic Q waves in the electrocardiogram (ECG)
   * New or presumed new significant ST-segment-T wave (ST-T) changes or new left bundle branch block (LBBB).
   * Identification of an intracoronary thrombus by angiography or autopsy
   * Imaging evidence of new loss of viable myocardium or a new regional wall motion abnormality.
3. Type 1 (spontaneous myocardial infarction(MI)) in the third universal definition of MI: MI consequent to a pathologic process in the wall of the coronary artery (eg, plaque erosion/rupture, fissuring, or dissection), resulting in intraluminal thrombus.
4. Infarct related artery (IRA) showed that acute thrombus formation, IRA occlusion or stenosis ≥95%、≥90%～95%、≤90%，thrombolysis in myocardial infarction (TIMI)0-3 flow.
5. PCI(percutaneous coronary intervention)intervention（PCI for STEMI within 12 hours after symptom onset）.
6. Signed informed consent.

Exclusion Criteria:

1. Combined valvular heart disease, cardiomyopathy, blood diseases, skin diseases, rheumatic diseases, ischemic cerebrovascular disease, tumor, etc.
2. Previous myocardial infarction.
3. Previous PCI and coronary artery bypass graft(CABG).
4. Chronic total occlusion(CTO)lesions.
5. Ear malformation.
6. Ocular diseases.
7. Participating in a clinical study.
Age Related Changes in Calciotropic Hormones and Their Impact on Male Osteoporosis

The purpose of this pilot study is to generate preliminary data regarding the skeletal effects of age-related changes in calcium and vitamin D metabolism in older men.


Eligibility Criteria:
Inclusion Criteria:

* healthy men age 50 yrs and older

Exclusion Criteria:

* smokers
* known history of metabolic bone disease, known history of hypogonadism or renal insufficiency.
Effect of Intermittent Pedicle Clamping on Hepatocellular Injury During Liver Surgery

In order to prevent excessive blood loss during liver surgery, an intermittent Pringle manoeuvre (IPM) can be applied. This implies a temporary clamping of the portal vein and hepatic artery in the hepatoduodenal ligament in order to occlude hepatic inflow. The optimal duration of the IPM is unknown. This randomized controlled trial aimed to analyse differences in hepatocellular damage after 15 minutes or 30 minutes IPM during liver surgery for primary or secondary liver tumours.

Surgical procedure Patients were anaesthetized using isoflurane and propofol. They routinely had an epidural catheter, urinary catheter, two peripheral venous catheters and indwelling catheters in a jugular vein and radial artery. Body temperature was maintained using a Bair Hugger system (Arizant Healthcare Inc. Eden Prairie, Minnesota).

The surgical procedure was performed using a subcostal bilateral incision and Olivier retractors to improve exposure. After dissection of the teres hepatis ligament, the liver was mobilized. Thereafter, an intra-operative ultrasound was performed to define the position of the tumour in relation to vascular and biliary structures. As IPM was not routinely applied, a patient was randomized for 15 minted IPM (15IPM) or 30 minutes IPM (30IPM) only after the surgeon had decided a complete Pringle manoeuvre would be required. During 15IPM or 30IPM, the complete portal triad was clamped using a rubber sling. The time of inflow occlusion was adapted to the need according to the randomization protocol. Occasionally, the left or right pedicle was ligated after protocolled IPM. Five minutes reperfusion intervals were applied during which transection was stopped and cut surfaces were gently compressed to ensure hemostasis. A Cavitron Ultrasonic Surgical Aspirator (CUSA system 200 macrodissector, Cavitron Surgical Systems, Stamford, Connecticut) and Argon beam coagulation (Force GSU System, Valleylab, Boulder, Colorado) were used for liver transection. A stapler device or clamps were used for transection of the hepatic veins. Central venous pressure was maintained below 5 centimetre of water (cm H2O) during transection to reduce venous back-bleeding. After surgery, the weight of the resection specimen was recorded. Perioperative care was protocolled, as described earlier.

Eligibility Criteria:
Inclusion Criteria:

* patients \> 18 years of age and \< 100 years of age
* primary or secondary liver tumours requiring liver surgery

Exclusion Criteria:

* pre-existent liver disease (e.g. inflammatory liver disease, cirrhosis, inborn errors of metabolism)
* cholangiocarcinoma requiring biliary tract reconstruction during surgery
* steroid hormone medication
* tumours deemed irresectable during liver surgery
* laparoscopic liver surgery
Effects of Robot-assisted Arm Training on Respiratory Muscle Strength, Activities of Daily Living and Quality of Life in Stroke Patients: A Single-blinded Randomized Controlled Trial

Stroke is the leading neurological disease in the world that causes long-term disability. The most common cause of disability after stroke is motor impairment resulting from brain damage which ultimately cause respiratory and functional limitation. Respiratory muscle weakness including the diaphragm leads to biomechanical change in respiration which can reduce vital capacity and total lung capacity of stroke patients. The weakness of diaphragm and abdominal muscle also leads to decrease in maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) in stroke patients.

Respiratory muscle training such as inspiratory or expiratory muscle training is commonly used to improve the respiratory muscle strength and function in stroke. However, it was reported that respiration is closely related to upper limb function because the muscle of upper extremities surrounds the dorsal muscle of trunk and in order to breath, the movement of trunk is necessary, which in turn is related to the movement of the upper limbs.


Eligibility Criteria:
Inclusion Criteria:

1. 18 year and above
2. Acute and sub-acute stroke patients
3. had MIP values lower than 70% of those predicted when adjusted for age and sex,
4. had no facial palsy, aphasia, or dysarthria, which would prevent respiratory muscle strength testing
5. Ischemic or Hemorrhagic stroke
6. No medical history of respiratory or lung disease

Exclusion Criteria:

1. patients with increased intracranial pressure, uncontrolled hypertension, decompensated heart failure, unstable angina, recent myocardial infarction, complicated arrhythmias, pneumothorax, bullae/blebs in the preceding 3 months
2. Any pulmonary or lungs disease
3. Any neurological conditions other than stroke
4. Using medications that could interfere with neuromuscular control or cause drowsiness.
5. Severe cognitive function (Mini-Mental Test result \<24)
6. Chronic stroke
7. Recurrent stroke, brain stem stroke, and aphasia were excluded.
Study Evaluating Local Susceptibility Patterns Associated With Tigecycline in Comparison to Other Antibiotics

Various bacterial organisms will be tested in order to compile information regarding the effectiveness of tigecycline against certain bacteria seen in local communities.

This is a prospective, microbiologic in vitro evaluation which will study the susceptibility of tigecycline in disk diffusion on clinical bacterial isolates collected from inpatients and outpatients. Fourteen hospital centers participated in the program. In vitro efficacy of tigecycline will be determined through the in vitro disk diffusion activity, using FDA breakpoints.

Eligibility Criteria:
Inclusion Criteria: Any protocol-specified microorganism isolated from the samples collected from hospitalized patients and outpatients
A Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of 100 mcg of Env 2-3 in MF59

To evaluate the safety and immune response of 100 mcg Env 2-3 antigen administered on days 0, 30, 180, and 365.

Preliminary immunologic data from protocol VEU 005B show evidence of the development of functional antibodies in the form of increased peptide binding and development of neutralizing antibodies. Evaluation of an antigen dose having potentially greater immunogenicity is therefore of particular interest.

Preliminary immunologic data from protocol VEU 005B show evidence of the development of functional antibodies in the form of increased peptide binding and development of neutralizing antibodies. Evaluation of an antigen dose having potentially greater immunogenicity is therefore of particular interest.

Twelve healthy volunteers receive injections of 100 mcg Env 2-3 in MF59 emulsion and two volunteers receive MF59 only on days 0, 30, 180, and 365. Follow-up continues for 6 months after the last injection.

Eligibility Criteria:
Inclusion Criteria

Subjects are:

* Normal, healthy adults (by history and physical examination) who fully comprehend the purpose and details of the study.

Exclusion Criteria

Co-existing Condition:

Subjects with the following conditions or symptoms are excluded:

* Positive syphilis serology (such as VDRL) unless positive test is due to a documented clinical event that occurred and was treated 5 or more years prior to enrollment.
* Circulating hepatitis B antigenemia.

Subjects with the following prior conditions are excluded:

* History of immunodeficiency, chronic illness, or autoimmune disease.
* Evidence of depression or under treatment for psychiatric problems during the past year.

Prior Medication:

Excluded:

* Immunosuppressive medications.

Prior Treatment:

Excluded:

* Blood transfusions or cryoprecipitates within the past 6 months.

Identifiable high-risk behavior for HIV infection, including:

* history of intravenous drug use; syphilis, gonorrhea, or any other sexually transmitted diseases (including chlamydia or pelvic inflammatory disease) in the last 6 months; more than two sexual partners, or sexual contact with a high-risk partner, in the preceding 6 months.
Effect of Laser Therapy Versus Anterior Re-positioning Splint in the Treatment of Disc Displacement With Reduction

comparing the effects of Laser therapy with anterior re-positioning splint and a placebo group on clinical signs and symptoms of temporo-mandibular dis-function and assessing articular disc morphology and configuration with magnetic resonance imaging.

to compare the clinical effects of Laser therapy as assessed with research diagnostic criteria of temporo-mandibular disorders to a group that received anterior re-positioning splint therapy and a control group that received placebo Laser. Diagnosis for disc displacement with reduction was performed with magnetic resonance imaging before treatment. assessment of the clinical and MRI findings was again performed after a 3 months observation period.

Eligibility Criteria:
Inclusion Criteria:

1. Patients having TMD in the form of disc displacement with reduction as verified from signs and symptoms during clinical examination and confirmed from the MRI.
2. Good general health: The patient must be medically free from any systemic disease or health problems.
3. Adult patients 18 years old and above.
4. No previous orthodontic treatment.
5. No previous TMJ treatment or surgery.

Exclusion Criteria:

1. Patients with multiple missing posterior teeth.
2. Muscle pain due to systemic disease.
3. Dental related pain.
4. Congenital abnormality, neoplasia or acute trauma.
5. Previous TMJ treatment or surgery.
6. Any medical condition that prohibits MRI acquisition.