cyrilzakka/clinical-trials huggingface dataset:
Gastric Content Ultrasound Monitoring Prior to Extubation in Critically Ill Children

Nearly half of critically ill children are intubated and enterally fed according to recent guidelines. However, no evidence-based recommendation are available regarding fasting times prior to extubation.

When an extubation is planned, children do not always present with normal neurological status yet, and are at risk of vomiting and aspiration. Extubation may also fail and require re-intubation with similar risks. Thus, pre-operative fasting guidelines are often transposed to the paediatric critical care setting, aiming for an empty stomach at extubation, with perceived decreased risks of aspiration. However, the gastric and gut motility pathophysiology is significantly different in critically ill children (frequent gastroparesis, liquid continuous feeding, etc.) compared to planned surgery children. The extrapolation of practice validated in the latter population may be inadequate. The stomach may be empty more or less rapidly than expected, leading to unnecessary prolonged fasting times or inappropriately short fasting times respectively.

Gastric ultrasounding monitoring may help assessing gastric content prior to extubation.

Investigators hypothesise gastric content clearance may be different in critically ill children prior to extubation, compared to pre-operative paediatric guidelines for elective surgery.


Eligibility Criteria:
Inclusion Criteria:

* 0 to 17 year old children admitted to pediatric intensive care unit
* intubated (oral or nasal tracheal tube)
* gastric enteral feeding affording at least 25% of the nutritional target (estimated with Schofield equations)
* No opposition from one of the 2 parents (or legal representatives)

Exclusion Criteria:

* anatomical anomaly of the stomach location (e.g. post surgery)
* Difficult access to perform gastric ultra-sounding (drains, plasters, dressings etc.)
* mobilization to right lateral decubitus at risk
Trial of Early Initiation of CGM-Guided Insulin Therapy in Stage 2 T1D

This protocol is an intervention study to determine the best education and monitoring strategy for children ages 2-20 years with pre-symptomatic type 1 diabetes (T1D) because there currently exists no clinical guidelines for management of these children in early-stage T1D. This study hypothesizes that the trajectory of T1D can be changed, substantially reducing HbA1c and risk of DKA at diagnosis, through (1) careful monitoring of children progressing from stage 2 to stage 3 T1D using continuous glucose monitor (CGM) technology, (2) staged education targeted to assist families in recognizing evolving dysglycemia, and (3) addressing glycemic abnormalities with early initiation of insulin.

Specific Aims:

Perform randomized controlled trial of intensive follow-up of stage 2 T1D participants utilizing continuous glucose monitoring (CGM) technology and early education of families to guide early insulin therapy with the goals of:

maintaining HbA1c less than 7.0%. avoiding adverse outcomes: ER visits, hospitalizations, DKA and severe hypoglycemia improving diabetes knowledge through optimal planned education as opposed to 'a crash course' at unexpected diagnosis event.

evaluating patient/caregiver satisfaction with diabetes care received evaluating impact of activity on glycemic profile Collect longitudinal biomarkers of beta-cell stress and dysfunction in stage 2 T1D.

Use longitudinal CGM data combined with "gold-standard" OGTT and HbA1c measures to provide evidence for CGM-based diagnostic criteria for stage 2 and stage 3 T1D.

Perform cost-analysis of intensive follow up protocol.

Eligibility Criteria:
1. Individuals identified in stage 2 T1D through ongoing screening studies at the Barbara Davis Center (ASK, DAISY, TrialNet, and TEDDY) who have given permission to be contacted about study opportunities.
2. Presence of islet autoimmunity with high risk of progression:

   i. positive for multiple islet autoantibodies at 2 or more visits -OR- ii. positive for a single high-affinity islet autoantibody at 2 or more visits
3. Evidence of dysglycemia (Stage 2 T1D) using any one of the following criteria:

I. Americal Diabetes Association (ADA) criteria:

1. fasting plasma glucose 100-125 mg/dL
2. OR 2-hour OGTT plasma glucose of 140-199 mg/dL
3. OR A1c 5.7-6.4%
4. OR ≥10% increase in A1c from previous visit

II. Dysglycemia on OGTT (TrialNet Criteria):

a. glucose above 200 mg/dL on 30, 60 OR 90 minute values

III. Dysglycemia on CGM worn for at least 5 days:

1. ≥15% of values above 140 mg/dL
2. OR peaks ≥ 200 mg/dL on ≥2 days
3. OR average sensor glucose ≥120 mg/dL

IV. Dysglycemia on finger stick blood glucose:

1. Fasting BG above 110 mg/dL on 2 or more days
2. OR 2 hour post-meal BG above 150 mg/dL on ≥ 2 days
3. OR single random BG \> 200 mg/dL
Short-term Function and Pain After Treatment for Dupuytren's Disease

This study will evaluate short-term pain and function associated with percutaneous needle aponeurotomy (PNA) and injections of the enzyme collagenase clostridium histolyticum in patients with Dupuytren's disease. Scores on outcome measures will be compared between groups to determine whether treatments differ in terms of hand function and pain during the early post-treatment period.

Percutaneous needle aponeurotomy (PNA) and injections of the enzyme collagenase clostridium histolyticum are two non-invasive treatment options for patients with Dupuytren's disease. While PNA has been offered for decades, injectable collagenase is relatively new. The effectiveness of each treatment has been compared in the literature; however, recovery, in terms of pain and short-term function has not been formally evaluated. The objective of this study is to objectively compare short-term function and pain outcomes associated with each of these two procedures in patients presenting with untreated Dupuytren's disease.

Eligibility Criteria:
Inclusion Criteria:

* Adult
* Dupuytren's disease diagnosis
* Consented to either percutaneous needle aponeurotomy or Xiaflex injection (patient choice)
* Able to read/write/speak English
* Must have an email address

Exclusion Criteria:

* Previous treatment for Dupuytren's disease
* Type 2 Diabetes Mellitus
* Pre-existing hand condition, previous hand surgery or trauma
A Study to Assess LBL-007 in Combination With Toripalimab and Axitinib Tablets Subjects With Advanced Melanoma

A phase I clinical study evaluating LBL-007 in the treatment of subjects with advanced solid tumors

This trial is a multi-center, single-arm, open-label, dose-escalation and expansion phase I study of LBL-007 combined with Toripalimab and Axitinib in the treatment of unresectable or metastatic melanoma.

It is divided into Study Part A and Study Part B. The safety, tolerability, kinetic characteristics, immunogenicity and preliminary efficacy of the subjects were evaluated. Both study part A and study part B are studied in two phases: dose escalation and dose expansion

Eligibility Criteria:
Inclusion Criteria:

1. Willingness to provide written informed consent and follow the study treatment plan and visit plan;
2. Aged ≥ 18 years at time of signing informed consent, male or female;
3. Eastern Cooperative Oncology Group (ECOG) performance status score 0 or 1;
4. Have life expectancy of at least 12 weeks ;
5. Subject with at least one measurable tumor lesion,according to the evaluation standard of solid tumor efficacy (RECIST 1.1).

Exclusion criteria:

1. Subjects are allergic to LBL-007, PD-1 and similar compounds or any component in the prescription;
2. Subjects with active central nervous system metastases (regardless of whether they have received treatment), including symptomatic brain metastases, meningeal metastases, or spinal cord compression, but asymptomatic brain metastases (no progression and/or at least 4 weeks after radiotherapy) No neurological symptoms or signs after surgical resection, and dexamethasone or mannitol treatment is not required);
3. Have received major surgery within 4 weeks before the first administration;
4. Subjects can not tolerate intravenous administration and have difficulty in venous blood collection (if there is a history of fainting needles and bleeding);
5. Women during pregnancy or lactation;
Chronic Migraine Epidemiology and Outcomes Study

This is a population internet-based study to characterize migraine clinical course and impact on family.


Eligibility Criteria:
Inclusion Criteria:

* History of migraine
* U.S. Member of Survey Panel
* Household member of study participant
* Ability to complete internet-based questionnaires

Exclusion Criteria:

* No access to internet
Prospective Cohort Observational Study of Placenta Accreta Spectrum Disorders

The incidence of placenta accreta spectrum disorders has shown an increasing trend worldwide due to the increase of cesarean section rate. Research on the outcomes of placenta accreta spectrum disorders primarily relies on retrospective analysis. The aim of this study was to establish a prospective, multicenter cohort in China in order to conduct further investigations on the clinical features, predictive capabilities, diagnostic methods, and pathogenesis of placenta accreta spectrum disorders.


Eligibility Criteria:
Inclusion Criteria:

1. Pregnant women aged 18-45;
2. at least one previous cesarean section ,regular antenatal examination and plan to give birth at research center
3. sign informed consent

Exclusion Criteria:

Irregular antenatal examination; Twins; Autoimmune diseases; Prepregnancy hypertension; Prepregnancy diabetes mellitus; Inheritance Sexual diseases; tumor; Abnormal liver and kidney function in early pregnancy
Retinal and Choroidal Microvascular Changes During Pregnancy Period Detected With Optical Coherence Tomography Angiography

During pregnancy many physiological changes and adaptations occur.Hormonal, hematological and hemodynamic changes are responsible for most of the ocular adaptations.We are planning to compare the choroid and retinal blood flow values and choroidal thickness of pregnant women and healthy non pregnant women with optical coherence tomography and optic coherence tomography angiography

During pregnancy many physiological changes and adaptations occur such as pulmonary, renal, endocrinological, haematological and visual system changes are happening. In previous studies, retinal and choroidal pregnancy-related changes in blood flow and choroidal thickness have been demonstrated. Optical coherence tomography angiography (OCTA) detects the contrast of motion in the blood flow, detecting the capillary of the retina and choroid.

It is a new functional method that visualizes the retinal networks and outer retina without using dyes.It is a non-invasive method that provides volumetric angiography information. In this study evaluation of the variability of choroidal and retinal blood flow changes and choroidal thickness, between trimesters of pregnancy and the non-pregnant control group is planned. Choroid and Retinal Blood Flow Values and Choroidal thickness in 41 pregnant women in the first trimester and it would be repeated at second and third trimesters. We compare measured values between trimesters and 45 healthy non-pregnant women.

Eligibility Criteria:
Inclusion Criteria:

* Healthy pregnant women Age \> 18 years

Exclusion Criteria:

* Systemical disease such as diabetes mellitus or hypertension
* Refractive error; spherical equivalence \> 4 diopters
* Ocular disease or surgery history
An Examination of Cognitive Fatigue Using Functional Neuroimaging

The purpose of this research study is to investigate the effectiveness of MS Disease modifying medications on cognitive fatigue in persons with relapsing remitting multiple sclerosis (RRMS). Cognitive fatigue is the kind of fatigue that occurs after intense mental concentration as after a session of problem solving.

The researchers aim is to investigate the effects of disease modifying treatments on cognitive fatigue and on specific brain areas that have been shown to underlie cognitive fatigue in individuals with Multiple Sclerosis (MS). The researchers will investigate the effects on the cognitive fatigue that develops during the performance of a demanding task, and also on how cognitive fatigue changes as a function of duration of treatment.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18-64.
* Relapsing remitting multiple sclerosis
* Been newly prescribed a new disease modifying medication for MS (either Zeposia or other high dose oral efficacy medication)
* or healthy volunteer who can speak English fluently.

Exclusion Criteria:

* History of head injury, stroke, seizures, or any other significant neurological event other than MS
* Flare up of MS symptoms within the past month.
* History of significant psychiatric illness (for example, bipolar disorder, schizophrenia, or psychosis) or a current diagnosis of Major Depressive Disorder.
* Pacemaker or other implanted electrical device, brain stimulator, aneurysm clip (metal clips on the wall of a large artery), metallic prostheses (including metal pins and rods, heart valves, and internal hearing aids \[cochlear implants\]), permanent eyeliner, implanted delivery pumps, or shrapnel fragments.
* left handed.
* Not able to have an MRI
Intervening Early: Key Adolescent Outcomes

This study follows children into adolescence who were first randomized to intervention condition in infancy.

Parents serve as co-regulators for their young children, helping them regulate behaviors, emotions, and physiology and supporting the development of healthy brain circuitry. Neglecting parents often fail to serve as co-regulators, which has implications for young children's self-regulatory capabilities and brain development. As children become older, these difficulties with self-regulation may become more pronounced. Adolescence represents a period of particular vulnerability for the emergence of mental health problems because of increasing demands for regulation of emotions and behaviors, coupled with on-going development of neural circuits that support emotional and behavioral regulation. The Attachment and Biobehavioral Catch-up (ABC) intervention was designed to help parents learn to interact in responsive and sensitive ways, with the expectation that children would show enhanced ability to regulate behavior, emotions, and physiology. The efficacy of the ABC intervention among parents involved with Child Protective Services (CPS) was assessed. Parents were randomized to ABC or to a control intervention. Children were followed at T1 (ages 1-4) and T2 (ages 8-10). At T1, more of the children in the ABC group developed secure and organized attachments than children in the DEF group, and children in ABC showed more normative production of cortisol, less expression of negative emotions, and poorer inhibitory control than children in DEF. ABC parents were more sensitive and showed more optimal neural activity than DEF parents. At T2, ABC children showed greater prefrontal cortex activation in response to threat than DEF children, suggesting better regulation to threat at the level of brain activation. Also at T2, children in the ABC group reported more secure relationships with parents, and showed more normative cortisol production and more optimal autonomic nervous system functioning than DEF children. In adolescence, the ABC intervention is expected to result in enhanced brain circuitry and more optimal functioning across domains as assessed at multiple levels of analysis relative to the control intervention. In the proposed study, behavioral and neurobiological development among 13-, 14- and 15-year-old adolescents whose parents were referred by CPS to a randomized controlled trial in infancy (n=120), and among low-risk adolescents followed since middle childhood (n=80) will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* Must have been included in middle childhood data collection

Exclusion Criteria:

* None
Endometrial Injury and IVF-ET Outcome

Implantation of the human embryo is the limiting factor in the success of invitro-fertilization and embryo transfer(IVF-ET).We wanted to find out whether creating a local injury to the endometrium in the non-transfer cycle would improve the IVF-ET outcome in the subsequent cycle.We believe that the injury created causes release of substances which help in implantation.

Study Design and Subjects: This is a randomized control study designed to evaluate the effect of local injury to the endometrium in non-transfer cycle in patients with previous failed IVF.

Patients will be randomly allotted to control and intervention group The patients in the intervention group Pipelle endometrial sampling 7-10th day and 24-26th day in the cycle prior to IVF transfer cycle.

Outcome Measures: Clinical pregnancy rate,implantation rate and ongoing pregnancy rate.

SAMPLE SIZE: 100 PATIENTS (50 in each group).

Eligibility Criteria:
Inclusion Criteria:

* Previous failed In-vitro fertilization embryo transfer cycle
* Patients who are good responders and have good quality embryos in the previous attempts
* Age of patients upto 37yrs

Exclusion Criteria:

* Those detected to have endometrial tuberculosis in the past, including those treated with Antituberculosis treatment
* Those with intramural fibroid distorting the endometrial cavity/sub-mucous myoma
* Those with sonographically detected hydrosalpinx
Impact of Biomarkers on Pharmacokinetics and Pharmacodynamics of Ticagrelor

It is general that there are many factors for individual differences of drugs in clinical application, of which genetic factors accounted for more than 20%. Ticagrelor is a new-type receptor antagonist of P2Y12 and it is not affected by the influence of CYP2C19 polymorphism. With lack of predicted biomarkers, especially the research data of Chinese, it has the important significance in studying individual differences of ticagrelor in the antiplatelet efficacy and safety, through the pharmacogenomics research.

The aim of this study is to determine the polymorphism of drug metabolizing enzymes, drug transporters and drug target genes in Chinese population. By detecting the gene polymorphism, we intend to study the pharmacokinetic/ pharmacodynamics/ pharmacogenomics (PK-PD-PG) correlation of ticagrelor and provide scientific basis for accurate medication guide for people to use ticagrelor.


Eligibility Criteria:
Inclusion Criteria:

(I)Chinese Healthy Volunteers

* In accordance with the inclusion criteria for each bioequivalence trial of ticagrelor;
* Sign informed consent of the research;
* Complete to collect indexes of pharmacodynamics and pharmacogenomics in the cycle with control drug.

(II)Chinese Patients

* With diagnosis of acute coronary syndrome (ACS), included unstable angina, non ST segment elevation myocardial infarction and ST segment elevation myocardial infarction;
* More than 18 years of age, male or female;
* Never received ticagrelor in a month and intend to take ticagrelor or have received ticagrelor for more than one week continuously；
* sign informed consent.

Exclusion Criteria:

(I)Chinese Healthy Volunteers

* In accordance with the exclusion criteria for each bioequivalence trial of ticagrelor;

(II)Chinese Patients

* With history of immunodeficiency disease, including positive HIV index;
* Positive Hepatitis B surface antigen (HBsAg) and HCV index;
* Combined therapy of CYP3A potent inhibitors (e.g., ketoconazole, itraconazole, voriconazole, telithromycin, clarithromycin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, Atazanavir, etc.), CYP3A substrate of narrow therapy window (e.g., cyclosporine, quinidine, etc.) and potent inducers of CYP3A (e.g., rifampin, phenytoin, carbamazepine, etc.) in 14 days before treatment with ticagrelor;
* Severe liver dysfunction and abnormal renal function;
* Uncontrolled hypertension, or systolic blood pressure \> 180mmHg or diastolic pressure \> 110mmHg during screening;
* Include contraindications of ticagrelor, such as hypersensitivity, active bleeding, moderate or severe liver disease, previous history of intracranial hemorrhage, gastrointestinal hemorrhage in the past 6 months and major operation within 30 days.
Study of Decidual Stromal Cells to Treat COVID-19 Respiratory Failure

This is a research study to see how safe and effective decidual stromal cells are in treating patients with respiratory failure (breathing problem where not enough oxygen is passed from the lungs into the blood) caused by COVID-19.

COVID-19 viral infectious disease that has lead to high numbers of critically ill patients or death due to respiratory failure.

Decidual Stromal Cells (DSC) may be useful in the treatment of acute respiratory distress syndrome (ARDS) by reducing lung inflammation and then time that patients require help with breathing (mechanical ventilation).

Eligibility Criteria:
Inclusion Criteria:

* Able to provide informed consent for participation in the study, either by the participant themselves or by the legally acceptable representative (LAR)
* Virological diagnosis of SARS-CoV-2 infection (PCR)
* Acute respiratory distress syndrome (ARDS) not due to cardiac causes
* Receiving mechanical ventilation

Exclusion Criteria:

* Severe comorbidity with life expectancy \<3 months according to investigators assessment
* Currently receiving extracorporeal membrane oxygenation (ECMO)
* Patients with established positive bacterial blood cultures prior to enrollment or suspicion of superimposed bacterial pneumonia
* Patients with diagnosed significant pulmonary embolism or deep vein thrombosis in the previous 3 months
* Patients who have been intubated for more than 48 hours
* Known hypersensitivity to dimethyl sulfoxide (DMSO) or to porcine or bovine proteins
* Acute co-morbidity within 7 days before inclusion such as stroke
* History of severe chronic history of heart disease, recent myocardial infarction or unstable angina, lung disease (requiring home oxygen), pulmonary hypertension, or liver comorbidities
* Malignancy that requires treatment in the previous two years (excluding non-melanoma skin malignancies treated by excision, or cryotherapy)
* History of immunosuppression (immunomodulators or anti-rejection drugs in past year, or active disease, autoimmune disease on treatment, transplant recipients) or anaphylaxis
* Refusal of blood products
* Severe co-morbidity/co-morbidities which in the opinion of the investigators would compromise safety assessments
* Pregnant or breast-feeding
* Actively participating on another trial of an investigational agent for ARDS
* Unacceptable laboratory blood tests for alanine aminotransferase (ALT)/aspartate aminotransferase (AST), neutrophils, or platelets