cyrilzakka/clinical-trials huggingface dataset:
Compare the Efficacy of Different Laryngeal Mask Size Selection Methods in General Anesthesia in Children

The laryngeal mask is widely used in general anesthesia in children. Selection of an appropriately sized laryngeal mask airway (LMA) is critical to ensure safe and effective use of the device. In children, the appropriate size of the LMA to be used is usually determined by the patient's weight. Up to now, this is the gold standard method, but the weight-related technique is not always possible. The patient's weight is sometimes unknown or medical staff do not remember the relationship between weight and size. Moreover, there are no constant correlations between laryngeal airways and body indices such as height and weight, so that the standard method could cause an inappropriate size of laryngeal mask airway to be chosen. Researchers from Spain introduced a new technique to determine the size of the LMA in children by choosing the LMA that best matched the combined widths of the patient's index, middle and ring fingers, but needs to be formally evaluated in clinical application. In order to compare the application effects of two methods (weight-related and three-fingers), we designed a research plan.

The allocation sequence is generated by computer random number generation, and the allocation is placed in sequentially numbered opaque sealed envelopes by a non-investigator. Enrolment and data collection are performed by trained research staff who are not involved in the care of the patients. The treating clinicians are not blinded to the assignment group, but all other staff involved in both the collection and collation of data are blinded to group allocation. The primary measurement is the oropharyngeal leak pressure (OLP) at the recommended intracuff pressure. The secondary measurements included insertion time, fibreoptic view grade, insufficient ventilation, and the occurrence of complications such as postoperative sore throat. The sample size was calculated to be 390 by a statistical software based on previous research results. The continuous variables were expressed as means ± standard deviation (SD) whereas categorical variables were expressed as frequency and percentage for data description. P \<0.05 was considered statistically significant.

Eligibility Criteria:
Inclusion Criteria:

* children aged from 3 to 14yr, underwent elective ophthalmic surgery, had an American Society of Anesthesiologists physical status rating of I or II

Exclusion Criteria:

* Patients with lung disease, known airway problems, upper respiratory tract symptoms or any condition that may increase the risk of gastro-oesophageal regurgitation, or any anatomical abnormalities, especially those related to the head, neck or limbs.
Opportunistic Screening for Asymptomatic Left Ventricular Dysfunction in Coronavirus Disease 2019 (COVID19) Survivors

Coronavirus Disease 2019 (COVID-19) emerged in December 2019, and in mere few months has resulted in a pandemic of viral pneumonia. Substantial proportion of patients with COVID-19 have biochemical evidence of myocardial injuries during the acute phase. Possible mechanisms including acute coronary events, cytokine storm, and COVID-19 related myocarditis, have been postulated for the cardiac involvement in COVID-19. It is uncertain whether COVID-19 survivors are at risk cardiac dysfunction including cardiac arrhythmia and heart failure.

The prospective screening study aims to evaluate the possible latent effects from COVID-19 in COVID-19 survivors. COVID-19 survivors 4-6 weeks after hospital discharge will be recruited from the Infectious Disease clinic, Queen Mary Hospital with standard 12-lead electrocardiogram, serum troponin, NT-proBNP, and standard transthoracic echocardiogram.

The outcome measures include (1) new onset cardiac arrhythmia, (2) N Terminal (NT)-proBNP elevation above the diagnostic range of heart failure, and (3) newly detected left ventricular dysfunction.

Coronavirus Disease 2019 (COVID-19) emerged in December 2019, and in mere few months has resulted in a pandemic of viral pneumonia. As of April 2020, over 2 million populations were infected and more than 150,000 deaths globally. In the initial report from Wuhan, China, up to 27.8% COVID19 patients had an elevated troponin level indicating myocardial damage during the index hospitalization for COVID. This is nearly 10-folded higher than that of other common viral illnesses such as influenza (2.9%). Possible mechanisms including acute coronary events, cytokine storm, and COVID-19 related myocarditis, have been postulated for the cardiac involvement in COVID-19. Nonetheless, it is unknown whether COVID-19 survivors are at risk cardiac dysfunction including cardiac arrhythmia and heart failure.

The prospective screening study aims to evaluate the possible latent effects from COVID-19 in COVID-19 survivors. COVID-19 survivors 4-6 weeks after hospital discharge will be recruited from the Infectious Disease clinic, Queen Mary Hospital. Standard 12-lead electrocardiogram, serum troponin, NT-proBNP, and standard transthoracic echocardiogram will be performed for COVID-19 survivors.

The outcome measures include (1) new onset cardiac arrhythmia, (2) NT-proBNP elevation above the diagnostic range of heart failure, and (3) newly detected left ventricular dysfunction.

Eligibility Criteria:
Inclusion Criteria:

* Survivors of PCR-confirmed COVID-19
* 2-6 weeks after hospital discharge with 2 consecutive negative polymerase chain reaction (PCR) for severe acute respiratory syndrome (SARS) coronavirus (CoV)-2.

Exclusion Criteria:

* Pre-existing heart failure
* Pre-existing left ventricular systolic dysfunction (left ventricular ejection fraction \< 50%)
* Pre-existing atrial fibrillation
* Failure to provide informed consent
Efficacy and Safety Following Use of a Novel Nicotine Replacement Therapy

A comparison of a novel nicotine replacement therapy and placebo treatment in smokers motivated to quit smoking.

Efficacy and safety study following use of a novel nicotine replacement therapy.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older male and female cigarette smokers motivated and willing to stop smoking
* Female participants of child-bearing potential should use a medically acceptable means of birth control.
* Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study and consents to participate.

Exclusion Criteria:

* Unstable angina pectoris or myocardial infarction during the previous 3 months.
* Pregnancy, lactation or intended pregnancy (non-pregnancy will be verified by urine pregnancy test for female participants of child-bearing potential).
* Participation in other clinical trials within the previous three months and during study participation.
Orelabrutinib Combined With Pemetrexed For Relapsed/Refractory Central Nervous System Lymphoma

This is a prospective single arm, phase II clinical trial to observe the efficacy and safety of orelabrutinib combined with pemetrexed in the treatment for patients with relapsed/refractory central nervous system lymphoma.


Eligibility Criteria:
Inclusion Criteria:

1. Age between 18 to 75 years old (including 18 and 75)
2. Diagnosed as diffuse large B-cell lymphoma; Recurrence or progression of central nervous system disease confirmed by imaging ± tissue biopsy pathology or cerebrospinal fluid flow cytometry; Secondary central nervous system lymphoma can also be admitted when the systemic disease is well controlled
3. Having at least one measurable lesions
4. World health organization-Eastern Cooperative Oncology Group Performance Status (ECOG) 0-2 ( ECOG 3 due to tumors can be included after being fully assessed by the investigator)
5. Life expectancy no less than 1 month
6. enough main organ function
7. Pregnancy test within 7 days must be negative for women of childbearing period, and appropriate measures should be taken for contraception for women in childbearing period during the study and six months after this study
8. Agreeing to sign the written informed consents

Exclusion Criteria:

1. Poor peripheral disease control of secondary central nervous system lymphoma
2. Patients used pemetrexed or orelabrutinib in the past
3. Active malignant tumor need be treated at the same time
4. Other malignant tumor history
5. Serious surgery and trauma less than two weeks
6. Patients with active tuberculosis
7. Systemic therapy for serious acute/chronic infection
8. Congestive heart failure, uncontrolled coronary heart disease, arrhythmia and heart infarction less than 6 months
9. HIV-positive, AIDS patients and untreated active hepatitis
10. Patients with a history of deep vein thrombosis or pulmonary embolism less than 12 months
11. Patients with a history of mental illness or drug abuse
12. Poor compliance during the trial and/or follow-up phase
13. Allergies or people who are known to be allergic to any active ingredients, excipients, mouse-derived products or heterologous protein contained in this trial
14. Researchers determine unsuited to participate in this trial
Growing Together: Women in Opioid Treatment and Their Infants

This study evaluates the effectiveness of the home-based therapeutic parenting intervention BRIGHT with pregnant women and postpartum mothers with opioid use disorders (OUDs) and their infants. It examines whether participation in the BRIGHT intervention improves parent-child relationships, parenting capacities, the mother's overall mental health, participation in OUD treatment, infant social-emotional development and decreases the likelihood of child maltreatment. Approximately half of the participants will receive the BRIGHT intervention, monthly handouts, and the standard of care at the maternal-fetal medical clinic and the other half will receive STAR, or Enhanced Treatment as Usual (TAU+), which includes monthly handouts and the standard of care from the medical clinic.

Growing Together is a two-armed pragmatic randomized controlled trial of a trauma and evidence-informed therapeutic parenting intervention, BRIGHT. This trial lasts approximately 9 months.

BRIGHT has been offered to young children ages birth through 6 years and their parents affected by substance use disorders (SUDs) to mitigate the effects of trauma, promote resilience, and enhance the quality of parent-child relationships and parenting skills. BRIGHT has been successfully piloted and evaluated within residential treatment and outpatient opioid treatment programs for pregnant women/mothers with SUDs and OUDs with young children .

For this study, BRIGHT has been adapted for home-based delivery for pregnant women receiving treatment for OUDs and is offered from the 3rd trimester of pregnancy until the infant is about 6 months old. Participants in both arms will be recruited from a high-risk maternal-fetal medicine clinic and followed for approximately 15 months. The two arms of the trial are 1) the BRIGHT (Building Resilience through Intervention, Growing Healthier Together) intervention, and 2) STAR. Both arms of the study will receive the typical standard of care of at a high-risk maternal-fetal medical clinic and 7 monthly psycho-educational handouts on child development specifically for mothers in recovery.

The investigators are testing the effectiveness of the adapted version of BRIGHT by utilizing measures to examine if participation in BRIGHT decreases the likelihood of child maltreatment, improves parent-child relationships, parenting capacities, the mother's overall mental health, participation in OUD treatment, and infant social-emotional development.

Eligibility Criteria:
Inclusion Criteria:

* A patient at BUMC RESPECT clinic with history of opioid use or history of polysubstance use
* 18 years orolder
* Being treated with methadone, naltrexone, or suboxone
* In 3rd trimester of pregnancy
* Deemed by MDs able to give informed consent
* Planning to parent infant after birth
* Willing to participate in RCT

Exclusion Criteria:

* Planning to relinquish custody of neonate
* Residing, or expected to reside post-birth 20+ miles from Boston
* Deemed by MDs unable to give informed consent
Prophylactic Closed Incision Negative Pressure Wound Therapy on Abdominal Wounds - Clinical and Economic Perspectives

This study evaluates whether specialist negative pressure dressings reduce the risk of wound infections after operations when compared to conservative dressings, and if one negative pressure dressings works better than another. The study will look at patients who have had an open operation on their bowel and the wound closed at the end of the operation.

Surgical site infections (SSI) can affect up 41% of patients post-operatively. They are associated with significant healthcare and patient costs, and increased patient morbidity and mortality.

Specialist post operative dressings with negative pressure wound therapy are available, and the WHO do recommended for use in high risk wounds, taking resources into account. However no further recommendations are available.

This study will explore the rate of post-operative wound infections in adult patients undergoing open abdominal surgery on the bowel, and compare the rate of wound infections in these patients in relation to three different dressing types used after their operation. The study aims to determine if any of the dressings used within the study are associated with lower post-operative wound infection rates, and compare the overall costs of using each dressing type, including both direct healthcare costs and societal costs. Finally, it will evaluate participant's quality of life outcomes after open abdominal surgery, specifically relating to their wound.

Eligibility Criteria:
Inclusion Criteria:

* Emergency, trauma or elective contaminated abdominal operations within general surgery and/or colorectal surgery
* Abdominal wounds closed at time of operation and expected to heal by primary intention
* Patients who have the capacity to consent
* To include complex abdominal wounds with existing infection where wounds have been closed and expected to heal by primary intention
* To including graft or flap sites as part of general surgical procedure
* Patients who are able to complete questionnaires post operatively, either alone or with assistance

Exclusion Criteria:

* Wounds where an appropriate seal cannot be obtained
* Wounds left open and expected to heal by secondary intention
* Patients known to have allergy or sensitivity to dressings being used
* Patients who lack the capacity to consent
Innate T Cells and TKI Discontinuation

After more than a decade of treating chronic myeloid leukemia (CML) with tyrosine kinase inhibitors (TKI), the discontinuation of treatment represents the expected new revolution. The investigators has recently discovered a new innate CD8+ T population in healthy subjects, the Eomes+ KIR+ CD8+ T population, with anti-tumor properties. Remarkably, these cells are numerically and functionally deficient in patients at diagnosis and then restored in patients in major molecular remission (MMR) on TKI. Our work performed in a retrospective pilot study interestingly shows a very significant increase in the proportion of CD8+ Eomes+ KIR+ T cells within total T cells in patients with prolonged success in stopping their ITK (≥ 2 years).Thus, the investigators postulate that CD8+ Eomes+ KIR+ T cells are a predictive signature of TKI arrest success in CML. The investigators will rely on a prospective translational study of this cell contingent during treatment cessation.

To perform this research, the investigators have started a prospective translational study to collect samples in CML patients with successful versus patients who have failed TKI therapy discontinuation. The investigators plan to study functional and phenotypic characteristics of innate T cells. The investigators also plan to evaluate in vitro whether immune check points inhibitors could help to restore the innate T lymphocytes population.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years old
* Diagnosis of CML-PC according to the criteria of the European Leukemia Net (Baccarani et al, 2013)
* Patients treated with TKI for at least 3 years (imatinib, nilotinib, dasatinib, bosutinib, ponatinib)
* Patients meeting the criteria of the French STIM study: deep molecular response of MR4.5 type (threshold of 0.0032%) or MR5 type (threshold of 0.001%) for at least 2 years,
* Free subject, without guardianship or curatorship or subordination
* Patients benefiting from a Social Security system or benefiting from it through a third party

Exclusion Criteria:

* Refusal to participate in the research
* Patients not benefiting from a Social Security scheme or not benefiting from it through a third party
* Persons benefiting from enhanced protection, namely minors, persons deprived of their liberty by a judicial or administrative decision, persons staying in a health or social institution, adults under legal protection, and finally patients in emergencies
* Patient having stopped treatment for another reason than: deep molecular response of MR4.5 (threshold of 0.0032%) or MR5 (threshold of 0.001%) for at least 2 years

Translated with www.DeepL.com/Translator (free version)
Critical Incidents Related to Anesthesia and Intensive Care: A Study in a Tertiary Hospital

Critical incidents in anesthesia is one of the most valuable methods to assess the safety of anesthesia practice among different types of patients. Most of the studies in this regards are retrospective with many drawbacks and pitfalls like absence of information in the records of the patients.

In the investigators' study, the investigators will follow the critical incidents among patients who underwent surgery under anesthesia whether regional or general over the next two years from 2016 to 2018, by examining the patients records from the hospital database and recording the events that occur to the patients.

Over the forthcoming two years, the investigators will study in details critical incidences that may occur to patients in the perioperative period like; acute hypoxic event, acute major hemorrhage, acute airway obstruction and others that may endanger the life or one of the patient organs and whether the patient survive the acute event or die.

These critical incidences will be collected and all information about it will be known in order to be studied and to know were was the defect and eventually to improve the safety of practice of anesthesia and surgery.

Eligibility Criteria:
Inclusion Criteria:

* patients who undergo anesthesia and surgery
* patients who are exposed to a critical incidence

Exclusion Criteria:

* patients who undergo anesthesia and surgery and do not expose to critical incidents.
Bioequivalence of Two Formulations of Biphasic Insulin Aspart 70 in Healthy Male Subjects

This trial is conducted in Africa. The aim of this trial is to investigate the bioequivalence of two formulations of biphasic insulin aspart 70 in healthy male subjects.


Eligibility Criteria:
Inclusion Criteria:

* Considered generally healthy upon completion of medical history and physical
* examination, as judged by the investigator
* Body Mass Index (BMI) between 19-29 kg/m\^2 (both inclusive)
* Minimum body weight of 65 kg
* Fasting blood glucose between 3.8-6.0 mmol/L
* Glycohemoglobin (HbA1c) below 6.4 %
* Non-smokers

Exclusion Criteria:

* Clinically significant abnormal hematology, biochemistry, urinalysis or ECG (electrocardiogram) screening tests, as judged by the investigator
* A history of any illness that, in the opinion of the Investigator and/or Sponsor, might confound the results of the study or pose additional risk in administering the investigational product to the subject
* History of or current addiction to alcohol or drugs of abuse as determined by the investigator (positive drug/alcohol abuse screen)
* Hepatitis B or C
* Subjects with a first-degree relative with diabetes mellitus
* Known or suspected allergy to trial product or related products
* Smoking during the past three months
High-resolution Magnetic Resonance Imaging (MRI) Scans to Look for Spread of Melanoma to Nearby Lymph Nodes

The study is designed to see if a high-resolution MRI scan of lymph node areas near where a melanoma has been removed from the skin can pick up the spread of melanoma to those lymph nodes with a high degree of accuracy.

When a melanoma of the skin is diagnosed, there is some chance it can spread to nearby lymph nodes, and from there to other parts of the body. Currently, patients with melanoma at low risk for spreading to lymph nodes do not get the lymph nodes assessed except by a physical exam. Those at high risk for spreading to lymph nodes get one or more lymph nodes removed surgically to check for melanoma spread. But physical exam alone will often miss small areas of melanoma in lymph nodes; removal of lymph nodes by surgery is painful and can cause complications. Neither assessment tool is optimal.

This study is designed to see if use of very high-resolution contrast-enhanced MRI scans of lymph node areas near the primary melanoma site in the skin can accurately detect small areas of melanoma spread to those lymph nodes. If this turns out to be the case, in the future, MRI scans could potentially be an alternative for assessing lymph nodes, compared to physical exams alone or surgical removal of the lymph nodes.

In this study, patients with low risk melanoma will receive very high-resolution MRI scans of nearby lymph nodes every 6 months for 5 years of follow-up. If the MRI looks abnormal, the lymph nodes will be biopsied, and results from the biopsy compared to the results from the MRI.

Patients with high risk melanoma will get a baseline MRI of the nearby lymph nodes, and then one or more lymph nodes will be removed (usually by sentinel lymph node biopsy) regardless of the MRI results. Again, results from the biopsy will be compared to the results from the MRI. MRI's will still be repeated every 6 months to assess whether lymph nodes not removed at surgery develop any changes.

We plan to enroll 200 patients on this study and by the end of the study will have a measure of the sensitivity and specificity of high-resolution MRI scans in the detection of melanoma involvement of regional lymph nodes.

Eligibility Criteria:
Inclusion Criteria:

* history of invasive cutaneous melanoma stages 1-3 within 2 years of treatment of the melanoma by primary excision
* eligible whether or not a sentinel lymph node biopsy or regional lymph node dissection has been performed
* adequate renal function (creatinine 2 or less)
* life expectancy 2 years of more

Exclusion Criteria:

* history of severe claustrophobia precluding MRI scans
* known hypersensitivity or other contraindication to gadolinium contrast
* known presence of metastatic melanoma at sites beyond regional lymph nodes (stage 4)