cyrilzakka/clinical-trials huggingface dataset:
The Effect of Ultrasound-guided Erector Spinae Plane Block on Postoperative Analgesia in Radiofrequency Ablation Therapy

This is a double blind, randomized controlled trial to evaluate the efficacy of ESPB(Erector Spinae Plane Block) on postoperative analgesia in RFA( Radiofrequency Ablation therapy). We will include 80 patients, and randomly assign to ESPB(Chirocaine) group and control group(normal saline).We deduce Erector spinae plane block can be use as a postoperative analgesic way for patients who receive radiofrequency ablation of hepatocellular carcinoma.

Computed tomography guided radiofrequency ablation of hepatocellular carcinoma(HCC) has became a popular way to treat HCC. Although the wound is small and the patients can discharge on the next day, they have to suffer from moderate to severe pain. Nowadays Erector spinae plane block has been applied to many surgery as a postoperative analgesic strategy. We deduce Erector spinae plane block can be use as a postoperative analgesic way for patients who receive radiofrequency ablation of hepatocellular carcinoma. Besides, we will add contrast medium to evaluate the spread area of local anesthetics.

Eligibility Criteria:
Patients undergoing computed tomography guided radiofrequency ablation of hepatic tumor under scheduled general anesthesia, and fulfilled one of following inclusion criteria:

1. diameter of hepatic tumor is larger than 2 cm
2. distance of tumor site is near the hepatic surface \< 2cm

Exclusion criteria:

1. A history of allergic reaction to local anesthetics or iohexol
2. Renal insufficiency, creatinine clearance \< 30mL/min
3. Coagulopathy or other bleeding disorder that cannot perform nerve block
4. Under pregnancy or lactation
5. Opioid tolerant patient
Efficacy and Safety of Clesrovimab (MK-1654) in Infants (MK-1654-004)

The primary objectives of this phase 2b/3 double-blind, randomized, placebo-controlled study are to evaluate the efficacy and safety of clesrovimab in healthy pre-term and full-term infants. It is hypothesized that clesrovimab will reduce the incidence of respiratory syncytial virus (RSV)-associated medically attended lower respiratory infection (MALRI) from Days 1 through 150 postdose compared to placebo.


Eligibility Criteria:
Key Inclusion Criteria:

* Is a healthy male or female who is an early or moderate pre-term infant (≥29 to 34 weeks and 6 days gestational age) or a late pre-term or full-term infant (≥35 weeks gestational age)
* For the phase 2b cohort only: Has a chronological age \>2 weeks of age up to 1 year and is entering their first respiratory syncytial virus (RSV) season at the time of obtaining documented informed consent.
* For the phase 3 cohort only: Has a chronological age from birth up to 1 year and is entering their first RSV season at the time of obtaining documented informed consent.
* For participants in South Korea only: Weighs ≥2 kg

Key Exclusion Criteria:

* Is recommended to receive palivizumab per local guidelines or professional society recommendations.
* Has known hypersensitivity to any component of clesrovimab
* Has a bleeding disorder contraindicating IM administration
* Has had a recent illness with rectal temperature ≥100.5°F (≥38.1°C) or axillary temperature ≥100.0°F (≥37.8°C) within 72 hours predose
* Has received any vaccine or monoclonal antibody for the prevention of RSV
* Is currently participating in or has participated in an interventional clinical study with an investigational compound or device at any time before first dose administration or while participating in this study
Pharmacokinetics of Advantage Anti-Caries Varnish

The study aim is to characterize the kinetics of iodine and fluoride following topical application of a combined PVP-I and NaF anti-dental caries varnish in healthy adults.

The study was to characterize serum iodine and fluoride levels over 24 hours after application of a topical dental varnish in healthy adults 23 to 57 years old.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adults 18 y and older, at least 20 teeth, not taking prescription or OTC medications.

Exclusion Criteria:

* Pregnant, weighed less than 110 pounds, had oral mucositis, ulcerative lesions, sensitivity to shellfish or iodine or fluoride varnish, or had known hypothyroidism, hyperthyroidism, dermatitis herpetiformis, hypocomplementemic vasculitis, nodular thread with heart disease, multi nodular goiter, Graves disease, or autoimmune thyroiditis
Comparison of Hydro-dissection Versus Ultrasonic Aspirator in Division of Liver Parenchyma in Laparoscopic Resection

Background: until now, there is no agreement about the safest and feasible method for liver parenchyma transection during laparoscopic liver resection.

Study design: prospective, randomized, single-center The purpose of the study: comparison of short-term results of two methods of parenchyma liver transection during laparoscopic liver resection


Eligibility Criteria:
Inclusion Criteria:

* Patients with benign lesions (hemangioma, focal nodular hyperplasia \[FNH\], hepatocellular adenoma, biliary cystadenoma, hydatid echinococcosis \[only with total pericystectomy\]) and malignant tumors (colorectal cancer metastases in the liver \[CRLM\], hepatocellular carcinoma \[HCC\], intrahepatic cholangiocellular carcinoma, gallbladder cancer T1b-3NxMo without invasion into bile ducts and adjacent organs), which involves laparoscopic segmental or major resection of the liver.
* Gender: both, male and female
* Minimum age 18 years
* Maximum age: 80 years
* ASA physical status I-IV
* BMI up to 40 kg/m2
* No simultaneous extrahepatic intra-abdominal procedures (bile duct resection, colon resection, partial duodenum resection)
* Total bilirubin up to 100mmol/l if jaundice presents in non-cirrhotic patients
* If cirrhosis is present, class A and B according to CTP score

Exclusion Criteria:

* • Difficulty index \> 12 points (see below)

  * Tumor invasion of IVC or portal trunk (necessity of vascular reconstruction)
  * Repeated liver resection before laparoscopic resection (the single resection before is not a contraindication)
  * Simultaneous extra-hepatic intra-abdominal procedures (bile duct resection, colon resection etc.)
  * Age under 18 years
  * Age above 80 years
  * ASA physical status \>IV
  * BMI \> 40 kg/m2
  * Total bilirubin \>100mmol/l if jaundice presents in non-cirrhotic patients
  * If cirrhosis is present, class C according to CTP score
  * Persons who are incapable of giving consent
  * Pregnant or breast-feeding women
  * Patients enlisted in other studies
The Synergistic Effects of Home-management and Intermittent Preventive Treatment of Malaria in Children

This cluster randomised trial is proposed to assess the clinical impact of adding a seasonal intermittent preventive treatment (IPTc) schedule for children aged 3 -59 months to a home management of malaria (HMM) programme using AQ+AS in Ghana. The study will be conducted in the Kwaso sub district of the Ejisu-Juaben district of Ghana in which 6 communities will be randomised to implement an IPTc schedule alongside the HMM programme or HMM programme alone.

The study will run in three phases; a preparatory phase to set up and obtain baseline morbidity data from a cross-sectional survey; an intervention phase and a post intervention phase of cross-sectional survey and data evaluation and dissemination. A cohort of 546 study children randomly selected will receive three full treatment courses of AS+AQ intermittently during the April - Nov 2007 transmission season. Community-based drug distributors (CDDs) will administer all courses of IPTc. The first dose of each course will be directly observed by the CDDs who will educate mothers or caregivers to administer subsequent doses appropriately at home. Follow up visits to homes will be done by CDDs and field supervisors to ascertain adherence and to monitor adverse drug events. The incidence of clinical malaria and other secondary outcomes will be compared with those of another cohort of 546 study children who will not receive IPTc but may be treated under the HMM strategy alone with AS+AQ when necessary during the observation period.


Eligibility Criteria:
Inclusion Criteria:

* A child in the study cohort will be eligible to receive a course of IPTc (active or placebo) if the child has NO fever (a temperature of 37•5o C or above) or history of fever in the last 24 hours. However, fever is only a temporary exclusion criterion. If a child has fever when he/she is due for an IPTc course, treatment will be given for the fever and the IPTc course given one month after the fever has subsided. This interval between treatment of fever episodes and administration of an IPTc course is proposed in order to minimise the risk of overdosing since the same drug is used for both HMM and IPTc.

Exclusion Criteria:

* A child in the study cohort will not be eligible to receive a course of IPTc if:

  * The child has a clinical condition that may be classified as severe according to IMCI guidelines.
  * The child is known to suffer from chronic disease(s) e.g. sickle cell disease that might adversely affect the interpretation of study results.
  * The mother/caregiver withdraws consent.
Parent-QoL and Sleep Disordered Breathing

In this prospective case-control study the investigators will enrolled parents of 45 children younger than five years of age who were planned to undergo adenotonsillectomy due to an obstructive airway indication in an academic medical center. A group of parents to healthy children will comprise the control group.

Parents of children with any chronic illness may experience increased anxiety and reduced health-related quality of life (QoL).

In this study, the investigators will analyze QoL parameters among parents of obstructive sleep disordered breathing (OSDB) children before and after surgical treatment.

In this prospective case-control study the investigators will enrolled parents of 45 children younger than five years of age who are planned to undergo adenotonsillectomy due to an obstructive airway indication in an academic medical center. A group of parents to healthy children will comprisedthe control group.

The investigators will translate and validate the PAR-ENT-QoL questionnaire through forward-backward translation method.

Main outcome measure: The questionnaire was tested for reliability, consistency, reproducibility, responsiveness, and for its clinical use.

Eligibility Criteria:
Inclusion Criteria:

* Parents of children younger than five years old who suffered from OSDB and underwent tonsillectomy or tonsillotomy with or without adenoidectomy

Exclusion Criteria:

* We excluded parents of children who required immediate surgery or had any other chronic diseases (such as ADHD, asthma, allergic rhinitis or severe medical or mental impairments).
Memory Priming in General Anesthesia

Memory priming under general anesthesia is a phenomenon of incredible interest in the study of consciousness and unconscious cognitive processing, and for clinical practice.

However results from anesthesiological literature are divergent and methodologies vary.

To overcome these limits, the present study aims at better defining the phenomenon of memory priming under general anesthesia, manipulating as experimental variables both the anesthetic drug used and the stimuli primed.

Some patients may develop serious psychological sequelae after surgical intervention under general anesthesia due to implicit memory formation of intraoperative events.

A number of studies in the field of anesthesiology have tried to better define the phenomenon of implicit memory in general anesthesia, with conflicting results. While some studies demonstrated the existence of unconscious memory formation also under adequate general anesthesia (BIS ranging 40-60), others state that implicit memory formation is possible only during light sedation, and that, therefore, traumatic disorders due to unconscious intraoperative memories are imputable to inadequate anesthesiological intraoperative management. The methodologies used by these studies, however, are very heterogeneous, and often inaccurate from a cognitive point of view. Data from cognitive neuroscience, in fact, demonstrate that different linguistic material, e.g. abstract and concrete words, are processed and retrieved via different networks in the brain. Then, since different anesthetics are known to target different areas of the brain, it is assumable that implicit memory formation is influenced both by the specific drug used and by the type of stimuli primed.

Therefore in this experiment, the investigators aim at testing implicit memory for different word category, abstract vs. concrete words, in patients undergoing either propofol or sevoflurane general anesthesia. Also, a very strict methodology was used both for the construction of the stimuli and the stimulation and testing procedure, in order to maximize the priming effect and exclude the risk of false positive results. The investigators hypothesize that, considering the existing data on propofol and sevoflurane effects on the brain, and the known neural correlates for abstract and concrete word processing, the priming effect would be different for abstract and concrete words between patients under propofol or sevoflurane anesthesia.

Eligibility Criteria:
Inclusion Criteria:

* patient undergoing general anesthesia for back surgery
* American Society of Anesthesiology (ASA) physical status classification I or II
* Italian native speaker
* right handed (assessed with the Edinburgh Handedness Inventory)
* not to suffer from memory deficits, hearing impairment or any other medical/psychiatric condition that could affect the memory performance or hearing

Exclusion Criteria:

* to develop a postoperative cognitive dysfunction or delirium or any other medical complication that could prevent the memory testing or that could affect memory performance
Continuous Glucose Monitoring As Adjunct to Lifestyle Modification in Prediabetes

This is a 12-month prospective, open-label, non-masked, two arm randomized controlled trial comparing intermittently-viewed continuous glucose monitoring (iCGM) in addition to lifestyle modification programme (LMP) as compared with a LMP alone in individulas with impaired glucose tolerance (IGT). Following informed consent, participants will undergo screening where a fasting glucose, 75g OGTT, HbA1c, fasting lipid profile along with comprehensive medical and drug history to confirm eligibility. At week 0, participants will be randomised to CGM plus LMP versus LMP alone. Both groups will receive individualized structured LMP programme delivered by a dietitian and a fitness instructor. Outcomes will be evaluated by laboratory tests, physical measurement, physical activity and dietary compliance and questionnaires at Month 0, 4, 8, 12.


Eligibility Criteria:
Inclusion Criteria:

1. Impaired glucose tolerance as defined by will be defined as per the American Diabetes Association criteria based on 75g oral glucose tolerance test (OGTT) 2-hour glucose of between 7.8 and less than 11 mmol/L
2. Male or female age ≥ 18 years old and ≤ 65 years old.
3. BMI 18 to 40kg/m2
4. Willingness, ability and commitment to comply with LMP
5. Able to use a CGM as judged by investigator
6. In the opinion of the investigator, absence of any physical limitations, addictive diseases, or underlying medical conditions (including mental health) that may preclude the patient from being a suitable study candidate.
7. Written informed consent to participate in the study provided by the patient.

Exclusion Criteria:

1. Currently pregnant, lactating, as demonstrated by a positive pregnancy test at screening or planning pregnancy
2. Known diabetes
3. Current or previous use of glucose-lowering or weight loss drugs
4. Concurrent participation in other weight loss or lifestyle intervention programmes
5. Any active acute or chronic disease or condition that, in the opinion of the investigator, might interfere with the performance of this study.
6. Any active acute or chronic infectious disease that, in the opinion of the investigator, would pose an excessive risk to study staff.
7. Current use or recent exposure to any medication that in the opinion of the investigator could have an influence on the patient's ability to participate in this study or on the performance of the test device.
8. Extensive skin changes/diseases that preclude wearing the FGM on normal skin at the proposed application sites (e.g., extensive psoriasis, recent burns or severe sunburn, extensive eczema, extensive scarring, extensive tattoos, dermatitis herpetiformis).
9. Known uncontrolled thyrotoxicosis
10. Current use of steroids
11. Have a known allergy to medical-grade adhesives
12. Known current or recent alcohol or drug abuse
13. Currently participating in another investigational study protocol where the testing or results may interfere with study compliance, diagnostic results, or data collection.
14. An identified protected vulnerable patient (including but not limited to those in detention, or a prisoner).
Pharmacist Use of ECG to Inform Drug Therapy Decisions for Patients Receiving QT Prolonging Medications

Torsade de pointes (TdP) is a cardiac arrhythmia associated with QT interval prolongation which may lead to cardiac arrest. Prescription medications which cause QT interval prolongation are commonly used in daily practice. To lessen risk of TdP, pharmacists work to minimize combinations of QT interval prolonging drugs. If community pharmacists had real-time information about a patient's QT interval duration, this would have the direct ability to inform their decision making about which patients may be at highest risk of TdP and who may need heightened avoidance of QT prolonging drugs. This project will provide 3 community pharmacies with mobile ECG devices to easily determine QT intervals among patients who have a prescription profile alert for QT interval prolongation. Study outcomes will include: frequency of QT interval prolongation, changes in drug therapy related to QT interval determination, and patient and pharmacist satisfaction with having pharmacist assessment of QT interval.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female at least 18 years of age.
2. Subject is receiving a prescription medication for which there is a "QT/QTc interval prolongation" alert observed on the dispensing pharmacy prescription software.
3. English speaking

Exclusion Criteria:

1. Patients with implantable pacemakers or automatic implantable cardioverter defibrillators
2. Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.
3. Patient has known atrial or ventricular arrhythmia
The Prognostic Assessment of Extubation in Aged Patients With Multiple Organ Dysfunction Syndrome

The multiple organ dysfunction syndrome (MODS) has remained the major factor contributing to prolongation of intensive and mortality. It is reported that the mortality rates have varied between 20% and 100%, depending on number, severity, duration, type and combination, and definition of dysfunction. In our study, the investigators explore some comprehensive treatment technology to improved outcomes of MODS patients.


Eligibility Criteria:
Inclusion Criteria:

* age \> 60 years old;
* presence of altered organ function in an acutely ill patient such that homeostasis cannot be maintained without intervention;
* have trachea intubation after admitting to intensive care unit within 24 hours.

Exclusion Criteria:

* end stage multiple organ failure.
A Study in Lactating Mothers and Their Newborns to Analyse the Composition of Human Milk

The current longitudinal (max. 2-year) observational cohort study in 120 lactating mothers and their newborns will make it possible to explore human milk composition across different lactation stages, between different human milk groups, and in relation to maternal, perinatal, infant, and sample characteristics as well as to the microbiota of the infant.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant women in the third trimester of pregnancy (≥28 weeks) who have the intention to provide breastfeeding for at least 6 months post-partum.
* Age ≥ 18 years.
* Willingness to provide residual human milk.
* Living in proximity of NCRU (clinical site in NL).
* Dutch speaking and reading.
* Freezer -18°C available.
* Having mobile phone, tablet, or computer available.
* Signed informed consent from the subject (pregnant woman).
* Signed informed consent from the other parent and/or legally acceptable representative, of the unborn baby(s), aged ≥ 18 years.

Exclusion Criteria:

* Pregnant women known positive for human immunodeficiency virus (HIV), hepatitis B (HBV), or hepatitis C (HCV).
* Multiple pregnancy \> 2.
* Incapability of subjects to comply with study protocol as per the judgment of the site staff (e.g. fluency in local language, access to laptop/smartphone devices and internet connection required for data collection).
* Women (and their unborn baby(s)) with current or intended participation in any other clinical study involving investigational or marketed products.
* Employees and/or children/family members or relatives of employees of Nutricia Research or the participating site.

Continuation exclusion criteria (after birth)

* Stillbirth
* Newborn having any congenital abnormality, chromosomal disorder or severe disease that would prevent the infant from breastfeeding and/or growing normally based on the opinion of a health care professional and/or study physician.
* No donation of any milk sample within the first 8 weeks postpartum (timepoints week 1, week 1.5, and week 4).
Application of Ultrasonic Gray-scale Ratio in Differentiating Benign From Malignant Thyroid Nodules.

According to the grades of echogenicity to evulated thyroid nodules is a subjective process and is thus influenced by the observer's judgement. The investigators first proposed the ultrasound gray-scale ratio (UGSR) to explore its efficacy for differentiating papillary thyroid microcarcinomas from small nodular goiters.

Echogenicity is a common ultrasonic parameter to evaluate thyroid nodules. The echogenicity of the thyroid nodule was divided into 5 grades according to gray scale. Of the five categories, the diagnostic values of the hypoechoic and markedly hypoechoic categories have been widely accepted for thyroid malignant nodules. However, distinguishing between hypoechoic and markedly hypoechoic categories is a subjective process and is thus influenced by the observer's judgement. A more objective method should be proposed to differentiate papillary thyroid microcarcinoma(PTMC) from small nodular goiter(NG).

The investigators suspect the echo intensity of nodules could be reflected by values, as CT values reflecting the nodule density. The investigators first proposed the ultrasound gray-scale ratio (UGSR), namely, the ratio of lesion gray-scale value to surrounding normal thyroid tissue, and the previous study showed UGSR can better display the relationship of gray scale of PTMC or NG with surrounding normal thyroid tissue, and can make objective judgment of the nodules through quantitative results.

As the absolute ultrasound grayscale value is affected by the apparatus, scan gain, dynamic range, frequency, and operators. The investigators would collected different data acquired from different parameters to explore their potential relations.

Eligibility Criteria:
Inclusion Criteria:

* patients diagnosed as thyroid nodule.
* homo-echogenicity of normal thyroid tissue.
* able and willing to comply with all study requirements.

Exclusion Criteria:

* nodules are mainly cystic or calcified.
* pathology confirmed Hashimoto's thyroiditis.
* unable or unwilling to comply with all study requirements.