cyrilzakka/clinical-trials huggingface dataset:
PENG Block in Comparison With FICB for Hip Reconstruction in Children

The goal of this clinical trial is to test the hypothesis that performing a Pericapsular nerve group (PENG) block allows for more effective analgesia in the perioperative period during reconstructive surgery on the hip in children with cerebral palsy and spina bifida compared with Fascia illiaca compartment block (FICB).

The main question it aims to answer is: Is the PENG block an effective and safe method of pain relief for hip surgery in children? Participants will be randomized into two equal groups. The group who underwent US - guided PENG block, and the group who underwent US - guided FICB . In both groups we used 0.5% ropivacaine. The same postoperative analgesia regimen was applied by intravenous acetaminophen , oral ibuprofen . In case of ineffectiveness of the prescribed drugs, promedol was used intramuscularly. The postoperative consumption of promedol, time to first rescue analgesia, numerical pain score (NRS) (for children from 7 years old), FLACC score, measurements of A.N.I. monitor MDMS and the side effects will be recorded

Eligibility Criteria:
Inclusion Criteria:

* reconstructive surgery on the hip joint
* children with cerebral palsy
* children with spina bifida
* age 3 - 18 years.

Exclusion Criteria:

* contraindications to the use of local anesthetics
* contraindications to performing an invasive procedure
* ASA \> 3
Evaluate the Pharmacokinetics, Safety, and Tolerability of Nirsevimab in Healthy Chinese Adults

The purpose of this study is to evaluate the Pharmacokinetics, Safety, Tolerability of Nirsevimab in Healthy Chinese Adults.

This is a Phase 1, randomized, double-blind, placebo-controlled study to evaluate the PK, safety and tolerability, and ADA of nirsevimab when administered as a single fixed IM dosage to healthy Chinese adult subjects. Enrolment is planned at a single study center in China. Approximately 24 subjects will be randomly assigned in a 3:1 ratio to receive nirsevimab (n = 18) or placebo (n = 6). All subjects will be followed for approximately 150 days after dosing to assess safety, PK, and ADA response.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 to 45 years
2. Weight ≥ 45 kg and ≤ 110 kg and Body Mass Index of 19 to 26 kg/m2
3. Healthy Chinese subjects (both male and female)
4. Normotensive
5. Normal electrocardiogram (ECG) within 28 days prior to Day 1

Exclusion Criteria:

1. Acute illness at study entry (pre-dose on Day 1)
2. Fever ≥99.5°F (37.5°C) on day of dosing
3. Any drug therapy within 14 days prior to Day 1 (except contraceptives).
4. Receipt of immunoglobulin or blood products within 6 months prior to study entry.
5. Receipt of any investigational drug therapy within 120 days prior to investigational product dosing or planned to receive any investigational drug therapy within 150 days after investigational product dosing.
6. Previous receipt of any marketed or investigational mAb.
7. Previous vaccination against RSV.
8. History of immunodeficiency or receipt of immunosuppressive medications during the prior year.
9. History of asthma.
10. History of autoimmune disorder.
11. Evidence of any systemic disease on physical examination.
12. Evidence of infection with hepatitis A, B, or C virus, syphilis, or human immunodeficiency virus.
13. Any clinically significant abnormal laboratory assessments at screening.
14. Pregnant or nursing mother.
15. Alcohol or drug abuse
Assessment of the Occlusal Characteristics

The objective of this study is to assess the occlusal characteristics of primary dentition among Egyptian preschool children.

This cross-sectional study was based on examination of the primary dentition of healthy preschool Egyptian children ,The objective of this study is to assess the occlusal characteristics of primary dentition among Egyptian preschool children.

Eligibility Criteria:
Inclusion Criteria:

* Egyptian children.
* Children are medically free.
* Children with a complete set of primary dentition without any permanent teeth. -Teeth free of extensive caries which affect the mesio- distal and occluso- gingival dimension.

Exclusion Criteria:

* Children with developmental anomalies.
* Children with any oral habits.
* Children with cognition problems.
* Children with a history of an obvious alternative cause for malocclusion (e.g. trauma, syndromes).
* Participant's caregivers refuse to give consent.
Cohort Study to Assess Impact of Chemotherapy Plus Bevacizumab on Health Related Quality of Life in First Line Metastatic Colorectal Cancer

The primary aim of this french multicenter national study is to assess and compare time to quality of life score deterioration (targeted dimensions : global health, fatigue and emotional functionning of EORTC QLQC30 according to the first line chemotherapy associated with bevacizumab in metastatic colorectal patients.


Eligibility Criteria:
Inclusion Criteria:

* age\> 18years
* metastatic colorectal cancer (non resectable)
* 1st chemotherapy including bevacizuman

Exclusion Criteria:

* treatment contre-indication
Autism Intervention Research Network for Behavioral Health (AIR-B II): Deployment Into Elementary Schools

The primary goal of this study is to identify efficacious and cost effective intervention strategies that can improve academic and psychological outcomes for children with ASD, and can be feasibly be implemented at fidelity by school personnel in under served elementary schools. Two simultaneous interventions will occur.

In intervention 1, students with ASD in inclusion classrooms will be randomized to the Playground Intervention or a waitlist control group. In the Playground Intervention, UCLA/ROC/UPENN staff will work with school personals (teachers, paraprofessionals) to increase peer engagement on the yard.

In intervention 2, students in special day classes will be randomized to the 'Schedule Tools Activities Transitions' Intervention (STAT) or wait-list control. In the STAT Intervention, UCLA/ROC/UPENN staff will work with teachers to implement behavioral strategies in the classrooms.

In both interventions, the conditions are: 1) Immediate treatment, where the training will begin immediately after baseline measures are completed. 2) Wait-list treatment, where the training will begin the follow school year.


Eligibility Criteria:
Inclusion Criteria:

1. Child: Child has to meet the following criteria: 1) Child's primary classroom teacher has consented to participate, 2) Child meets ADOS research criteria for autism spectrum disorder, 3) Child is between 5-11 years old, 4) Child's parents consented to have child participate, and 5) Child is placed in inclusion classroom or self-contained special education classroom for a minimum of 50% of the school day.
2. Adult: School teachers and paraprofessionals working with children with ASD.

Exclusion Criteria:

1. Child: Participants will be excluded from the study if child has co-morbid disorders such as cerebral palsy, Fragile X, Down syndrome. Child has profound vision or hearing lose.
2. Adult: Participants will be excluded from the study if the adult is not a teacher, administrator, teaching assistant, yard attendant, related services provider, or a paraprofessional.
KN046 in Patients With Recurrent or Metastatic Esophageal Squamous Cell Carcinoma

This is an open-label, phase II study of KN046 combined with chemotherapy and palliative radiotherapy in patients with recurrent or metastatic esophageal squamous cell carcinoma to evaluate the safety, efficacy and tolerance.


Eligibility Criteria:
Inclusion Criteria:

* Signed inform consent form(ICF)
* Age ≥ 18 years and ≤ 75 years, male or female
* Histologically or cytologically documented recurrent or metastatic esophageal squamous cell carcinoma, with indications of radiotherapy and without prior systemic treatment
* At least one measurable lesion according to Response Evaluation Criteria In Solid Tumors（RECISIT） v 1.1
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Adequate organ function
* Female patients and males with partners of childbearing potential should be using highly effective contraceptive measures (failure rate of less than 1% per year). Contraception should be continued for a period of 24 weeks after dosing has been completed.
* Ability to comply with treatment, procedures and pharmacokinetics (PK) sample collection and the required study follow-up procedures

Exclusion Criteria:

* Known brain metastasis or another Central Nervous System (CNS) metastasis that is either symptomatic or untreated.
* Patients who are participating or have participated in a study of an investigational drug within 4 weeks prior to the first dose of trial treatment.
* Patients who have received immune checkpoint proteins/antibody/medicine for treatment.
* Patients who have interstitial lung disease, or a history of pneumonitis that required oral or intravenous glucocorticoids to assist with management.
* Subjects with active autoimmune diseases or history of autoimmune diseases should be excluded
* Active Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV) infection.
* Known HIV infection or known history of acquired immune deficient syndrome (AIDS)
* Any unresolved the Common Terminology Criteria for Adverse Events (CTCAE) Grade ≥ 2 toxicities from prior anti-cancer therapy except for vitiligo, alopecia
* Patients who have serious hypersensitive reaction to monoclonal antibodies and have history of uncontrolled allergic asthma
Safety Study for an All-in-One Body and Personal Lubricant

This is a one-week study designed to test the safety of an all-in-one body and personal lubricant product during in-home use.

This is a single-center, medically supervised, single-arm study to evaluate the safety of an all over body and personal lubricant product in home-use conditions via clinical assessment. The study will consist of 2 visits. Subjects who meet the entrance criteria will receive investigational product (IP) and 2 subjective questionnaires for at-home completion. The subjects will be required to use the IP at least 2 times, as instructed over the 1-week home-use period. At the end of the study (visit 2) subjects will return to the study site, at which time the unused IP and questionnaires will be returned and a final clinical assessment will be performed.

Eligibility Criteria:
Inclusion Criteria:

* Normal, healthy adults in a stable, monogamous, ongoing heterosexual relationship with current partner within protocol-specified parameters
* Subjects comfortable discussing sensitive topics such as personal hygiene, menstruation and sexuality
* Able to read and understand English
* Voluntarily signs an Informed Consent document after the trial has been explained
* Willing to follow all study procedures, including birth control requirements

Exclusion Criteria:

* Any medical or mental health history or condition, or use of any product, drug or medication that per protocol (or in the opinion of the Investigator) might compromise the participant's safety or the analysis of results
* Participation as a research subject in a different trial within timelines dictated by protocol
* Participants with relationships or employment outside protocol-defined parameters
18F-F-AraG PET Imaging to Evaluate Immunological Response to CAR T Cell Therapy in Lymphoma

This is a pilot study in adult subjects with aggressive B-cell lymphoma who will receive commercial or research CAR T cell therapy as anticancer treatment.

Primary Objectives:

\* Explore the relationship of change in \[18F\]F-AraG PET signal following CAR T cell treatment with changes in T cell infiltration in tumor biopsies.

Exploratory Analyses:

* Explore the relationship of change in \[18F\]F-AraG PET signal in tumor lesions following CAR T cell treatment with clinical benefit rate (defined as Complete Response (CR) + Partial Response (PR) + stable disease (SD) ≥ 3 months) using RECISTv1.1 criteria
* Correlate the change in \[18F\]F-AraG PET signal in tumor lesions following CAR T cell therapy with maximum grade of Cytokine Release Syndrome (CRS) and neurotoxicity experienced.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years old
* Histologically confirmed aggressive B cell NHL including the following types defined by WHO 2008:

  * DLBCL not otherwise specified; T cell/histiocyte rich large B cell lymphoma; DLBCL associated with chronic inflammation; Epstein Barr virus (EBV)+ DLBCL of the elderly; OR
  * primary mediastinal (thymic) large B cell lymphoma
  * transformation of follicular lymphoma, marginal zone lymphoma or chronic lymphocytic leukemia to DLBCL will also be included
* Measurable disease by PET imaging (as defined by Cheson (2014)), that meets all the following criteria:

  * At least one measureable lesion away from head \& neck, liver, kidneys, GI tract and bladder
  * At least one biopsy-accessible lesion or lymph node.
* Express willingness to undergo low risk FNA or core biopsy of subcutaneous accessible lesion or lymph node.
* Scheduled to receive commercial or research CAR T cell therapy with axicabtagene ciloleucel (Yescarta ®) as part of anticancer therapy.
* Adequate renal and hepatic function, defined as:

  1. Creatinine clearance (as estimated by Cockcroft Gault) ≥ 60 mL/min or Cr \< 1.6 mg/dL
  2. Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤ 2.5x upper limit of normal (ULN)
  3. Total bilirubin ≤ 1.5 mg/dL, except in cases of Gilbert's syndrome
* Able to give informed consent. Subjects unable to give informed consent will not be eligible for this study

Exclusion Criteria:

* Women who are pregnant or breastfeeding.
* Subjects with significant GI disease involvement by PET imaging
* In the investigator's judgment, have any medical condition likely to interfere with assessment of safety or efficacy, be unable to tolerate additional radiation, or be unlikely to complete all protocol-required visits and procedures.
Development and Validation of The Post-RT LARS Prediction Model (PORTLARS)

Bowel dysfunction is common after a restorative rectal cancer resection. Neoadjuvant radiotherapy is an influential factor that impairs bowel function and quality of life. However, almost half patients who have received primary surgery with preoperative radiotherapy are able to restore a good or moderate bowel function in the long term. This multicenter observational study aims to identify the risk factors of severe bowel dysfunction after rectal cancer resection and neoadjuvant radiotherapy, in accordance with the LARS score, and to build a model that predicts long-term major LARS in the early stage of follow-up. Development and validation cohorts are enrolled from tertiary hospitals in China.


Eligibility Criteria:
Inclusion Criteria:

* Curative low anterior resection for nonmetastatic rectal cancer
* Preoperative radiotherapy

Exclusion Criteria:

* Death
* Metastasis or recurrence
* Postoperative radiotherapy
* Cognitive disorder
* Intestinal stoma
* Rectal cancer resection for \<12 months
* Stoma reversal for \<6 months
AIH Risk Stratification With Multiparametric MRI

The primary aim of this study is to investigate whether the baseline cT1 can predict those whose condition relapses following treatment withdrawal.

The secondary aim is to investigate correlation of cT1 with histology to explore utility as a monitoring tool.

A total of 97 patients with AIH will be recruited and divided into 2 arms. 20 of which will be treatment naive and the other 77 will have been on treatment for the past 18-24 months and will be coming in for therapy cessation review.

Patients with AIH who have been undergoing immunosuppressive treatment for 18-24 months will be invited for a series of multiparametric MRI (mpMRI) scans to assess the utility of LMS for monitoring characteristics of the disease.

This will be a prospective, cross-sectional, observational study recruiting 97 participants (20 of which will be treatment naïve at recruitment) from those patients scheduled for a liver biopsy for therapy cessation review. They will be consented and invited for a LiverMultiScan.

All patients whose treatment is ended based on histology results will be followed up over the subsequent 12 months, and those that experience a biochemical relapse or 'flare-up' will be invited for a second LiverMultiScan prior to their scheduled liver biopsy.

All participants will attend their planned outpatient hepatology appointment with their doctor, who will document the intended treatment plan for each participant in line with their usual care pathway. Their MRI scan will then be scheduled for the same day as their outpatient appointment or within a 7-day window after their appointment with the consultant.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing management for AIH being considered for treatment cessation
* Patients diagnosed with AIH, are treatment naïve, and will be undergoing biopsy as per clinical pathway
* Diagnostic biopsy prior to cessation of treatment (where possible)
* 18+ years of age.
* Ability to give informed consent

Exclusion Criteria:

* Any contraindication to MRI scanning
* Any clinically significant medical or psychiatric condition
Parent Led Implementation of a VR Social Skills Training Program for Children With ASD

The goal of this interventional trial is to establish training protocols to show feasibility of training parents and caregivers to administer the VR protocol. The primary objective is to evaluate the effects of treatment with Floreo Building Social Connections (BSC) on the AIM, a parent report survey that assesses core symptoms of ASD. The secondary objective is to explore the changes in social skills over time by using a multimethod outcomes battery. The Investigators will evaluate the effect of treatment with Floreo BSC on the Childhood Autism Rating Scales (CARS-2) in the study patient population. Additional secondary objectives include evaluation of the effects of treatment on adaptive skills as measured by the Vineland-3. Participants will be asked to complete questionnaires and utilize the VR program at clinic and at home.


Eligibility Criteria:
Inclusion Criteria:

* Patients or legally authorized representatives must provide written informed consent and be willing and able to comply with study procedures. Participants must provide informed assent as clinically appropriate.
* A diagnosis of autism spectrum disorder on the basis of the clinical judgement of a qualified clinician according to DSM-5 criteria, supported by either the Autism Diagnostic Observation Schedule or the Autism Diagnostic Interview-Revised.
* Participants must be able to tolerate VR therapy in the judgement of parent or caregiver and study staff.
* Female participants must either be unable to become pregnant (e.g., premenarchal, surgically sterile, etc.) or agree to use a highly effective method of contraception (e.g., intrauterine device, oral contraceptives, condom or diaphragm with spermicides, contraceptive sponge) from 28 days before the Baseline Visit to 45 days after the last treatment session. Females of childbearing potential must have a negative urine human chorionic gonadotropin pregnancy test at the Screening Visit.

Exclusion Criteria:

* History of photosensitive epilepsy or demonstrated photoparoxysmal response on prior electroencephalogram.
* Active diagnosis of migraine headache or migraine variant (abdominal migraine, cyclic vomiting syndrome) which is not adequately controlled by medication or other therapy.
* History of balance disorder including vertigo, motion sensitivity, or ataxia. Vestibular sensory deficits are not necessarily exclusionary.
* Primary sensory impairment (blindness, deafness).
* Motor disorder that would interfere with VR engagement.
Cough-Generated Aerosols of NTM in Cystic Fibrosis

Non-tuberculous mycobacteria (NTM) are opportunistic pathogens normally found in soil and water that are being cultured from Cystic Fibrosis (CF) airways at an increasing frequency. They have been demonstrated to cause clinically significant lung disease in some cases and the transmission of NTM, from person to person has been proposed. There are currently no standardized guidelines for isolation of those colonized or infected with NTM.

The investigators will measure particle droplet size from patients with CF who have positive sputum cultures for NTM with the hypothesis that they will be in a range that can spread infection.

Patients with a positive NTM sputum culture will be asked to participate in the study. If they agree to participate they will sign an informed consent and will be scheduled to come to the University of Florida Clinical Research Center for the testing.

The test will consist of the following: pulmonary function test, collecting a sputum culture if possible, coughing for 5 minutes into a tube connected to a canister, hypertonic saline and albuterol will be given after the 5 minutes of coughing and then they would repeat with another 5 minutes of coughing. There can be a break inbetween the coughing if needed.

Patients maybe asked to come back a second time if they develop a different type of NTM or start treatment for NTM.

Eligibility Criteria:
Inclusion Criteria:

* Age greater than or equal to age 8 years
* Confirmed Diagnosis of CF
* Sputum/Throat/Bronchoscopic culture positive for NTM within the last 12 months

Exclusion Criteria:

* Pregnancy
* Pneumothorax within the last 6 months
* Forced Expiratory Volume at one second \<30% predicted
* Hemoptysis greater than 1 tablespoon within the last 7 days
Sensitivity and Specificity of 3 Solutions of Allergen Extract for Diagnosis by Skin Prick Testing

A Phase III study to determine the sensitivity and specificity of three solutions of different allergen extracts for diagnosis by skin prick-test:

* 5 Grasses pollen,
* Birch pollen,
* Dermatophagoides pteronyssinus mite


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent to participate in the study
* Male or female subjects aged 5-60 years inclusive
* Female of childbearing potential must be on a reliable method of contraception and have a negative urine pregnancy test
* Presence of a clinical history of allergy: seasonal or perennial rhinitis, conjunctivitis and/or asthma during grass or birch pollen seasons (at least two pollen seasons) and/or due to mite exposure (at least two years)
* Subjects affiliated to a social security system

Exclusion Criteria:

* Pregnant or breastfeeding women
* Dermographism
* Absence of cutaneous reactivity
* Presence of cutaneous lesions on the forearms either preventing the performance of the test or potentially interfering with the interpretation of the test
* Subjects presenting unstable asthma or poor general health condition
* Subjects with past or current specific immunotherapy treatment for any of the 3 tested allergens (Grass, Birch pollens, D. pteronyssinus and/or D. farinae mites) in the previous 5 years
* Any oral antihistaminic treatment in the previous 3 days or 10 days in case of loratadine or desloratadine
* Subjects on anti-IgE treatment
* Subjects treated with beta-blockers and/or anti-depressives.
* Subjects currently participating in another clinical trial or still in exclusion period for a previous clinical trial
* Investigators, co-investigators, as well as their children or spouses and all the study collaborators
* Subjects under protection of the courts, legal guardianship or legal trusteeship