cyrilzakka/clinical-trials huggingface dataset:
An Optimization in the Postoperative Treatment in Head and Neck--surgical Patients.

Based on glycemic load (overall increase in blood glucose), it is investigated whether better glycemic control (large fluctuations in blood glucose to abnormal values are attempted) can improve the postoperative phase of head and neck surgical patients who receive Dexamethasone (glucocorticoid). Furthermore it is examined whether this optimization in treatment can result in reduced hospitalization time and fewer re-admissions.

Hypothesis:

Continuous blood glucose measurement and insulin therapy will optimize the postoperative phase of the embedded head and neck patient receiving Dexamethasone by reducing the incidence of hyperglycaemia and associated complications.

After surgical intervention, an insulin resistance condition will occur because of the following stress response. This condition will for the majority of cases results in poor glycemic control - and there will be a risk of hyperglycaemia in the hospitalized patient. This condition affects all cells in the body and therefore has associated complications such as bigger risk at multiple infections, longer healingprocess, poorer fluid balance, etc. Hyperglycaemia is associated with a poorer outcome for the patient, which can cause an increase in hospitalization days and multiple re-admissions. It is also common for the postoperative patient to experience nausea and pain as a result of both surgery and anesthesia and immobilization. To counter this, the patient receives Dexamethasone (steroid treatment).

This experiment is based on the fact that there is still insufficient attention at this postoperative insulin resistance. In a large randomized study from 2001(Van den Berghe), insulin therapy was initiated for intensive patients. This study points out that even moderate increases in blood glucose are associated with increased morbidity and that insulin therapy is both capable of reducing mortality and morbidity.

Eligibility Criteria:
Inclusion Criteria:

* All embedded head and neck-surgical patients receiving large packs of pre-medication, including 8-16 mg glucocorticoid.
* \>18 yrs.
* Expected admission time of a minimum of 1 day

Exclusion Criteria:

* Patients who do not understand and / or speak Danish
* Patients who are demented
* Patients included in primary robot surgery
* Ear-surgical patients
* Sinus surgery patients
* Day surgery patients
* Plastic surgical patients
* Patients who are scheduled to transfer to ICU
* Patients with Diabetes Mellitus type I
* Patients on dialysis
* If all preoperative blood samples and tests are not completed
* Type 2 diabetics in insulin therapy
* Anesthesia patients
* Patients who have received large packages of pre-medication twice - eg. due to cancelled operation.
Decision Aid to Technologically Enhance Shared Decision Making

Physicians face a challenge in promoting colorectal cancer screening (CRCS) in the face of multiple competing demands. A decision aid (DA) that clarifies patient preferences and improves decision quality could aid shared decision making (SDM) and be effective at increasing CRCS rates. However, exactly how such DA improves SDM is not clear. This 4-year R01 study funded by the National Cancer Institute seeks to provide detailed understanding of how an interactive DA affects patient-physician communication and SDM, and ultimately CRCS adherence.

This two-armed randomized controlled trial (300 patients/arm) will compare Colorectal Web (CW), the interactive DA, to a non-interactive control website in ten practices in Metro Detroit. Patients will be adults aged 50 years and over, not current on CRCS. In the clinic before the patient-physician encounter, participants will complete a Patient Baseline Survey. They will be randomized to CW or the control website. Data will be collected after the patient reviews the respective website (Post-Intervention Survey), during the patient-physician encounter (digital audio recording), and after it (Post-Encounter Survey). Chart audit will be performed six months after the encounter to determine whether the patient underwent CRCS.

Eligibility Criteria:
Inclusion Criteria:

* 50-75 years of age
* not current with colorectal cancer screening
* scheduled for HME, Health Maintenance Exam, or chronic care visit with participating physician
* able to read English
* current contact information

Exclusion Criteria:

* history of colon cancer or adenomatous polyps
* history of dementia or psychosis
* contraindication to CRCS
The Number of Mesogastria Containing Metastatic Lymph Nodes Predicts Gastric Cancer Prognosis

To investigate the impact of the number of mesogastria containing metastatic lymph nodes on the prognosis of gastric cancer.

Previous studies have established the existence of the mesogastrium, dividing it into six sections. The mesogastrium is identified during surgery and utilized in surgical practice. The aim of the present study was to further investigate its role in gastric cancer prognosis.Between January 2014 and January 2018, patients from the Tongji Hospital were included in this post-hoc analysis, including data from a randomized clinical study (DCGC01; http://www.clinicaltrials.gov, NCT01978444). Mesogastria containing metastatic lymph nodes (LNs) were referred to as metastatic mesogastria. Pathology reports were examined to assess metastases in the mesogastrium. Survival was assessed using Kaplan-Meier curves and multivariable Cox models.

Eligibility Criteria:
Inclusion Criteria:

1. older than 18, younger than 85
2. primary gastric adenocarcinoma confirmed by preoperative pathology
3. routine blood tests, liver and kidney functions and who health status score are within the range of tolerable surgery
4. it is expected to perform radical gastrectomy through d2+cme

Exclusion Criteria:

1. pregnant or lactating women
2. severe mental disorder or language communication disorder
3. preoperative imaging examination or intraoperative exploration found that the patient had the following conditions: tumor involving surrounding organs requiring combined organ resection, distant organ metastasis or R0 resection could not be achieved
4. those who are not suitable for laparoscopic surgery (such as extensive adhesion caused by anterior abdominal surgery and pneumoperitoneum for various reasons).
5. concurrent malignancies at other sites
6. emergency surgery patients
Cryoanalgesia Study

This study will investigate the feasibility of cryoanalgesia in patients undergoing cardiac surgery via a median sternotomy. Cryoanalgesia is a technique that uses extremely cold temperatures to temporarily ablate nerves and block pain signals. Cryoanalgesia has been used for decades for pain control after thoracic surgery and has been associated with decreased opioid consumption, decreased pain scores, and shorter hospital stays. The results of this study may lead to a useful alternative for pain control in cardiac surgery patients.


Eligibility Criteria:
Inclusion Criteria:

* Scheduled for elective CABG (coronary artery bypass graft) or single valve surgery via median sternotomy
* Reasonable expectation to be extubated within 24 hours postop

Exclusion Criteria:

* Prior history of surgery to the thorax (sternotomy, thoracotomy, thoracoscopy)
* Hemisternotomy approach
* History of cold urticaria, cryoglobulinemia, Raynaud's disease, or diabetic neuropathy
* Preoperative use of opioids
* History of chronic pain or associated syndromes
* Concurrent Cox maze procedure
* Need for post-bypass mechanical circulatory support (ECMO, IABP) or open chest
* Women who are pregnant or breastfeeding
* Patients who are unable to consent for themselves
Study of Erythropoietin in Newborns and Children

Erythropoietin (EPO) is a glycoprotein hormone with a molecular weight of 30.4 kDa, responsible for regulating erythropoiesis in adults, newborns and fetuses. During pregnancy, the concentration of maternal serum EPO increases linearly to allow for effective erythropoiesis over time. In the fetus, in the first 30 weeks of gestation, the liver is the main synthetic organ. Thereafter, there is a progressive transfer of the synthesis of EPO to the kidneys. In the long term, under normal conditions of oxygenation, the fetal synthesis of EPO is mainly ensured by the kidney.

Because of the impossibility of making EPO tissue reserves and the inability of EPO to pass the placental barrier, the concentration of circulating EPO in the fetus reflects the balance between production and elimination. During the last trimester of pregnancy, in the absence of patent hypoxia, fetal concentrations of circulating EPO are between 10 and 50 mIU /ml, while in amniotic fluid the EPO is found at lower concentrations, between 2 and 20 mIU /ml.

In adults, EPO synthesis is primarily renal, and incidentally hepatic, even if in certain pathological situations (end-stage kidney disease or polycystosis) the liver is able to take over and synthesize EPO with an electrophoretic profile similar to that of the EPO from the umbilical cord, but often in insufficient quantities.

The objective of this study is to describe the forms of EPO in newborns and to compare possible iso-forms with those of adults.


Eligibility Criteria:
Inclusion Criteria:

* infant or child under 1 year old hospitalized or consulting at CHU Dijon Bourgogne whose parents have not opposed participation in the study

Exclusion Criteria:

* child treated with recombinant erythropoietin
Brain Volumes of Very Low Birth Weight Infants Measured by Cranial Ultrasonography

Neonatal cranial ultrasound (US) remains the method of choice to detect brain injury in high risk preterm infants on neonatal intensive care units (NICU). It is a non-invasive, inexpensive bedside tool and examinations can be repeated as often as necessary without major disturbance of vulnerable infants. The anterior and posterior fontanelles from excellent acoustic windows to examine the deep midline and periventricular regions of the brain.Some data demonstrated that cerebral palsy can be accurately predicted with US. However, cranial US is not very suitable for investigating cortical regions or structures in the posterior fossa. There is limited data for very preterm infants.The investigators aimed to measure ventricular index, cranial height, biparietal diameter and calculate brain volume in a huge number of infants.


Eligibility Criteria:
Inclusion Criteria:

* both gender
* \<1500 gr \<32 week-
* 1-28 days neonates

Exclusion Criteria:

* Anomalies and no viability
Pilot Study About Safety and Efficacy of Atomized Intrapleural Lidocaine During Pleuroscopy

This study will evaluate the potential to decrease the use of IV anesthesia drugs in patients undergoing pleuroscopy administering lidocane standardly applied to the skin in combination with atomized lidocaine applied into the pleural cavity.

Most patient discomfort results from direct manipulation or contact with the parietal pleura during chest tube placement, talc instillation or pleural biopsy. This study intends to use combined IV, intradermal and intrapleural anesthesia during pleuroscopy procedures. Intrapleural atomized lidocaine will be applied directly to the parital pleura. This study will evaluate intravenous anesthesia reduction in subjects treated with intrapleural lidocaine, reduction in total procedure timeby minimizing interruptions due to poor pain control, reduce perioperative pain scores and improve patient comfort nad to determine safety of fixed dosage of 3 mg/kg intrapleural lidocaine given during pleuroscopy.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with pleural disease
* Patients undergoing pleuroscopy with talc with or w/o biopsy
* Patients aged 18 - 85
* Patients capable of signing informed consent

Exclusion Criteria:

* Severe congestive heart failure
* Hepatic failure, bilirubin \> 2mg/dl, ALT,AST 3XULN
* Prior use Lidocaine in 48 hrs
* Hx SA drug reaction to lidocaine or amide local anesthetics
* Second or third degree heart block (w/o pacemaker)
* Sever sinoatrial block (w/o pacemaker)
* Concurrent treatment with quinidine, flecainide, dsopyramide, procainamide (ClassI antirrhythmic agents)
* Prior use or amiodarone hydrochloride
* systolic BP \< 90mmHg
* bradycardia
* accelerated idioventricular rhythm
Race, Natriuretic Peptides and Physiological Perturbations

The purpose of the study is to understand the origins of differential response to beta-blockers in African-Americans and may provide insight regarding racial differences in cardiovascular risk.

The heart is an endocrine organ. The natriuretic peptides are hormones produced in the heart and are secreted in response to increased wall stress in atria and ventricles. The principal circulating NPs are Atrial Natriuretic Peptide (ANP) and B-type Natriuretic Peptide (BNP). The endocrine actions of NPs are natriuresis and dilatation of peripheral arteries.

The NPs concentrations are elevated in heart failure (HF) and hypertension (HTN) due to volume and pressure overload. Therefore, NPs are used as diagnostic and prognostic markers in heart failure. However, NPs role in healthy individuals is not known.

Previous studies have shown that reduced NP levels are associated with a greater risk of HTN. Moreover, African-Americans have lower resting NP levels than Caucasians. We hypothesize that relative NP deficiency in African American compared to Caucasian has the potential to contribute to increase risk of all-cause mortality, HTN, HF and its sequelae.

Evidence from multiple clinical trials has positioned beta-blockers as a standard heart failure therapy. Beta-blocker therapy leads to increased NP levels and suppression of Renin-aldosterone-angiotensin system (RAAS) system. Suppression of renin levels by beta-blockers has been shown as a potential mechanism of benefit in HF. However, study shows that beta-blockers are less effective in African-Americans compared to Caucasians in HF treatment. So, the investigators have proposed a pilot study to look for race-based differences in the NP and RAAS response to metoprolol in healthy individuals.

Additionally, exercise has been reported to increase NP levels. ANP increases more than BNP with exercise. But there is no data of NP changes in African-American with exercise. So the investigators have proposed a sub-study of race-based difference in ANP and BNP response to exercise.

40 African-American and 40 Caucasians normotensive or pre-hypertensive (healthy) individuals will be enrolled.

Eligibility Criteria:
Inclusion Criteria:

* 18 to 40 years
* Blood pressure less than 140/90 mm Hg
* Able to perform exercise capacity test
* BMI 18-30 kg/m2
* Willing to adhere to study drug

Exclusion Criteria:

* History of cardiovascular disease or use of medications for CVD
* History of hypertension or use of BP lowering medications
* Blood pressure less than 100/60 mm Hg
* Heart rate less than 60 beats/min
* Depression
* Diabetes or use of anti-diabetic medications
* Renal disease (eGFR \< 60ml/min/1.73m2)
* Current or prior smokers
* Pregnant or use of Hormone Replacement Therapy (HRT) or oral contraceptives (OCP) or steroids
Qudexy XR for the Prevention of Migraine in Children 6 to 11 Years Old

A Phase 4 study to evaluate Qudexy XR for the prevention of migraine in children 6 to 11 years of age.


Eligibility Criteria:
Inclusion Criteria:

1. Subject is a female or male 6 to 11 years of age, inclusive, at Visit 1 (Screening)
2. Subject weighs at least 17.0 kg and less than 50.0 kg at Visit 1 (Screening) based on 95 percentile weight for the age range.11
3. Subject has at least a 6-month history of headaches consistent with a diagnosis of migraine with or without aura (International Classification of Headache Disorders, 3rd Edition \[ICHD 3\]).
4. Subject had ≥8 self-reported headache days in the 28 days prior to Screening.
5. Subject has a PedMIDAS score \>10, indicating at least mild disruption in daily activities, and \<140, indicating extreme disability that may require more comprehensive, multi component therapy.

Exclusion Criteria:

1. Subject has continuous migraines, defined as an unrelenting headache for a 28-day period.
2. Subject is currently receiving treatment or has used Botulinum toxin (Botox®) within 3 months prior to Visit 1 (Screening).
3. Subject is currently receiving migraine prevention medication and has initiated or changed the dose within 28 days of Screening or is unwilling to avoid making a change during the duration of the study.
4. Subject has previously failed an adequate trial of topiramate (at least 3 months duration at a clinically appropriate dose) for prophylaxis of migraine headache due to lack of efficacy or AEs.
5. Subject has previously failed an adequate trial of \>3 migraine preventative medications.
6. Subject has a known history of allergic reaction to topiramate or any excipient in Qudexy XR.
7. Subject has a diagnosis or history of disease that may interfere with safety or evaluation of the study drug.
8. Subject is currently using an investigational drug or device or has used such within 30 days prior to Visit 1.
9. Subject has begun menses and any of the following:

   1. Subject has tested positive for pregnancy; OR
   2. Subject is pregnant, planning pregnancy, or lactating; OR
   3. Subject is taking an oral hormonal contraceptive (either combined \[estrogen and progestogen containing\] or progestogen-only) and is unable or unwilling to switch to an alternative highly effective contraceptive method.
Expressive Writing for Cancer Survivors

The purpose of this study is to determine whether a 1-day expressive writing intervention for adult cancer survivors improves resilience scores as measured by the Connor-Davidson Resilience Scale (CD-RISC).

The purpose of this study is to determine whether a 1-day expressive writing intervention for adult cancer survivors improves resilience scores as measured by the Connor-Davidson Resilience Scale (CD-RISC).

Eligibility Criteria:
Inclusion Criteria:

* Have ever received a cancer diagnosis
* Have completed cancer treatment (e.g., surgery, radiation, or chemotherapy)
* Are able to speak, read, write, and understand English
* Are cognitively able to provide consent
* Are able to travel to Durham to participate in the 1-day writing intervention

Exclusion Criteria:

-Cancer diagnosis was skin cancer that did not require additional treatment after surgical removal
PMCF Study Protocol for PROFEMUR® Gladiator Plasma Femoral Stems and PROCOTYL® L Beaded Acetabular Components

MicroPort Orthopedics (MPO) is conducting this post market clinical follow-up (PMCF) study to evaluate the safety and efficacy of its total hip arthroplasty (THA) components marketed in the European Union (EU). These types of studies are required by regulatory authorities for all THA devices that do not have medium to long-term clinical evidence available at the time of gaining approval to market in the EU. This study has been designed in accordance with the medial device directives (MEDDEV) 2.12/2 rev 2.


Eligibility Criteria:
Inclusion Criteria:

* Has undergone primary THA for any of the following:
* Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, or painful hip dysplasia;
* Inflammatory degenerative joint disease such as rheumatoid arthritis; or
* Correction of functional deformity
* Subject is implanted with the specified combination of components
* Subject is willing and able to complete required study visits or assessments

Previously implanted bilateral subjects can have both THAs enrolled in the study provided:

* the specified combination of components were implanted in both
* all other aspects of the Inclusion/Exclusion Criteria are satisfied
* enrollment does not exceed the subject count specified in the Clinical Trial Agreement
* the subject agrees to a second Informed Consent document specific to the second THA.

Exclusion Criteria:

* Subjects implanted with a metal-on-metal articulation
* Subjects implanted with non-MPO or non-Wright Medical Technology components (femoral heads, acetabular shells, acetabular liners) at the time of their primary THA in the enrolled THA
* Subjects skeletally immature (less than 21 years of age) at time of primary THA surgery
* Subjects currently enrolled in another clinical study which could affect the endpoints of this protocol
* Subjects unwilling to sign the Informed Consent document
* Subjects with substance abuse issues
* Subjects who are incarcerated or having pending incarceration
An Observational Study of OZURDEX® in Diabetic Macular Edema (DME)

This is a study of OZURDEX® use in clinical practice in patients with diabetic macular edema (DME).


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of DME in at least one eye treated OZURDEX® per clinical practice

Exclusion Criteria:

* None
Study of IMOVAX POLIO® Subcutaneous as a Booster Vaccine in Pre-school Age Children in Japan

The aim of the study is to assess the immunogenicity of SP059 (IMOVAX POLIO®: Inactive Poliovirus Vaccine) vaccine against poliovirus and safety after fifth dose.

Primary Objective:

* To investigate the booster vaccine response rate against poliovirus types 1, 2 and 3 one month following the vaccination dose with SP059 as 2nd booster

Secondary Objectives:

* To investigate seroprotection rates (percentage of subjects presenting poliovirus neutralizing antibody titers above 1:8 (1/dil.) at pre- and post-booster time points, Geometric mean titers (GMT) at pre- and post-booster time points and geometric mean of individual titer ratio (GMTR).
* To investigate the safety after dosing of SP059 as 2nd booster.

Participants will receive one dose of SP059 (at Visit 1) as a booster vaccination at an age from 4 to 6 years. They will be assessed for immunogenicity at baseline (pre-vaccination) and at 4-6 weeks post- vaccination.

Safety data including serious adverse events (SAEs) after vaccination will be collected during the study period.

Eligibility Criteria:
Inclusion Criteria:

* Aged 4 to 6 years inclusive on the day of inclusion
* Subjects who received 4 times an IPV-containing vaccine (DTaP-IPV or IPV) during first (3 doses) and second year of life (one dose)
* Informed consent form signed by the parent(s) or other legal representative
* Able to attend all scheduled visits and to comply with all trial procedures.

Exclusion Criteria:

* Fever ≥ 37.5°C (axillary temperature) on the day of inclusion
* Any serious disease whether acute or chronic
* Past or current medical history of Guillain-Barre syndrome, acute thrombocytopenic purpura or encephalopathy
* History of poliomyelitis infection
* History of a life threatening reaction to a vaccine containing the same substances of the study vaccine
* History of anaphylaxis or allergy to any of the study vaccine components
* Congenital or current/previous acquired immunodeficiency, immunosuppressive therapy such as long-term systemic corticosteroids therapy
* Participation in another clinical trial within 6 months before the trial inclusion
* Planned participation in another clinical trial during the present trial period
* Received oral or injected antibiotic therapy within the 72 hours prior to any blood draw
* Received antipyretics/analgesics/Non-steroidal anti-inflammatory drugs (considered as a single category) within 4 hours prior to vaccination
* Blood or blood-derived products received in the past or current or planned administration during the trial (including immunoglobulins)
* Any vaccination with live vaccines within the past 27 days preceding the trial vaccination
* Any vaccination with inactivated vaccines within the past 6 days preceding the trial vaccination
* Clinical or known serological evidence of systemic illness including Hepatitis B, Hepatitis C and/or HIV infection
* Subject ineligible according to the Investigator's clinical judgment.