cyrilzakka/clinical-trials huggingface dataset:
Mindfulness-Based Substance Use Prevention (MINDS-UP)

The goal of this clinical trial is to test the feasibility, behavioral/neural mechanisms, and preliminary efficacy of "MINDfulness-based Substance Use Prevention Program," or "MINDS-UP", a novel substance use prevention meditation intervention for children and adolescents between the ages of 10 and 14. The main questions it aims to answer are:

1. Is MINDS-UP feasible and what is its preliminary efficacy?
2. Are MRI protocol and procedures feasible?

An additional exploratory question is:

Are there neural and psychopathological mechanisms through which MINDS-UP might work?

Researchers will compare Sport - Prevention Plus Wellness (PPW) (an evidence based substance use prevention program) to Sport - Prevention Plus Wellness + MINDS-UP to examine the preliminary efficacy of MINDS-UP.

Participants will

* take assessment #1
* have 2 MRIs and take MINDS-UP, just take MINDS-UP or have a delayed start
* take assessment #2
* take PPW, a single remote and research assistant-delivered 45-minute session
* take assessment #3
* take assessment #4


Eligibility Criteria:
Inclusion Criteria:

* Youth is ages 10-14 years on the day of screening \[i.e., does not turn 15 before or on the day of screening\]
* Access to a smart phone, tablet, or computer with Wi-Fi
* English-speaking

Exclusion Criteria:

* Has been diagnosed with or received treatment for one of the following mental health problems: depression, bipolar disorder, schizophrenia, autism spectrum disorder, intellectual disability, or substance use disorder.
* Youth is actively involved in another Boricua Youth Study (BYS)
* Youth's sibling is or has previously been enrolled in MINDS-UP.
Symptom Spectrum and Risk Factors for Fever in Pediatric and Adult Patients With Omicron Infection

The omicron variant of coronavirus disease 2019 (COVID-19) has caused a global epidemic in 2022. The aim was to investigate the symptom spectrum and risk factors for fever in pediatric and adult patients with omicron infection. From April 8, 2022 to May 17, 2022, this prospective observational study included patients who attended the child-parent sections of the Fangcang shelter hospitals with laboratory-confirmed COVID-19. Patient data were collected from questionnaires. The risk factors for prolonged fever and high fever were identified by univariate and multivariate analyses.

Study design and participants A prospective multicenter study was designed. It was conducted in accordance with the Declaration of Helsinki (as revised in 2013). Informed consent was obtained for all participants. From April 8, 2022 to May 17, 2022, Patients who attended the child-parent sections of the Fangcang shelter hospitals in Shanghai, China, with laboratory-confirmed COVID-19 were included. Those who had poor compliance (defined as inability to comply with the protocol) were excluded. Data from the included cases were collected. Adult patients and caregivers of children patients received two kinds of questionnaires after admission. Type I questionnaire (supplemental material) for basic characteristic were finished as soon as they were admitted. Type II questionnaire (supplemental material) for symptom and medication use tracking were filled out every day until discharge. This study was approved by the ethics committee of Shanghai Children's Medical Center.

Definition of outcomes The outcomes were the likelihood of developing prolonged fever and the likelihood of developing high fever. Fever was defined as temperature ≥ 38.0℃. Prolonged fever was defined as fever for more than 2 days. High fever was defined as temperature ≥ 39.1℃.

Statistical analysis SPSS version 25.0 (IBM SPSS Statistics, Armonk, NY, USA) was used to analyze the data. Data are presented as median values and interquartile ranges (IQRs) for continuous variables and frequencies and percentages for categorical variables. The investigators used Mann-Whitney U test to compare continuous variables between two groups. The investigators used χ2 test or Fisher exact test to compare categorical variables. Univariable analysis was used to investigate the association of each clinical variable with the outcomes. To determine the risk factors for each outcome, multivariable analysis was performed by logistic regression with a stepwise variable model. Variables of P value \< 0.05 were candidates for multivariable analysis. Statistical significance was determined as a 2-sided P value of \< 0.05.

Eligibility Criteria:
Inclusion Criteria:

* hospitalized in the child-parent sections of the Fangcang shelter hospitals in Shanghai, China
* diagnosis of laboratory-confirmed COVID-19

Exclusion Criteria:

● have poor compliance (defined as inability to comply with the protocol)
How Improvement in Control of Diabetes Influences the Production of a Hormone Produced in the Gut Which Improves the Release and Action of Insulin.

The study is aimed at Type 2 Diabetics who are taking Metformin, but whose Diabetes remains poorly controlled. There are two additional medications already in use, Glimepiride and Sitagliptin will be compared to assess levels of improvement in Diabetes control.


Eligibility Criteria:
Inclusion Criteria:

* Diabetes Mellitus
* Currently on Metformin but poor glycaemic control,

Exclusion Criteria:

* Under 18 years of age
Prostate Cancer Burden and Heterogeneity Evaluation Towards Liquid Biopsy: a Correlation Study to 18FDCFPyL PET and Patients Outcome

This is a prospective, monocentric, proof of concept study aims to identify in prostate cancer patients, a potential relationship between CTC-PSMA positivity and 18F-PET-PSMA results as well as patient outcome.

Patients with 18F-PET-PSMA indication will perform imaging extension work-up as part of current practice. If they agree to participate in the study, a blood sample will be performed prior to the 18F-PET-PSMA standard imaging (T1).

In order to evaluate the potential relationship between CTC-PSMA and 18F-PET-PSMA imaging, the study will be presented to all patients seen in consultation for an extension workup for prostate cancer. This will allow to analyze the results in patients with different level of tumor burden afterward to define the following three groups based on imaging results:

Group 1 : no tumor volume Negative 18F-PET-PSMA (patients without uptake lesion)

Group 2 : low or medium tumor volume Positive 18F-PET-PSMA (patients with an uptake in prostate bed or with an oligo-metastatic extension (number of lesions \< 6))

Group 3 : high tumor volume Positive 18F-PET-PSMA (patients with a polymetastastatic extension (number of lesions ≥ 6)).

In each of these groups, the rate of patients with positive PSMA CTC will be analyzed (i.e. patient having at least one CTC-PSMA positive).

For patients with an indication of treatment by 177LuPSMA-617 (PLUVICTO®) according to standard practices, additional blood samples will also be collected at the following time points: 2nd cycle (T2) and 4th cycle of treatment (T3), just before injection. For these patients, data will be collected up to 6 months after the last treatment injection (clinical and biological data; results of tumor assessments based on 18F-PET-PSMA imaging).


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years
2. Histologically confirmed adenocarcinoma of the prostate
3. Indication for 18F-PET-PSMA imaging
4. Signed written informed consent
5. Patient able to participate and willing to give informed consent prior performance of any study-related procedures and to comply with the study protocol
6. Patient affiliated to a Social Health Insurance in France.

Exclusion Criteria:

1. Patients with a contraindication to 18F-PET-PSMA
2. Patient with an established neuro endocrine prostate cancer
3. Concurrent malignancy known to express a significant amount of PSMA (renal cancer, salivary gland tumors)
4. Any psychological, familial, geographic or social situation, according to the judgment of investigator, potentially preventing the provision of informed consent or compliance to study procedure
5. Patient who has forfeited his freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice).
Food-specific IgG4-guided Elimination Diets Improve Allergy Symptoms in Children

Allergic diseases in children are major public health concerns due to their widespread and rising prevalence. The most classic pathway to trigger allergy is type I allergy mediated by immunoglobulin E(IgE), but the role of immunoglobulin G4(IgG4) in allergic diseases is still worth exploring.we have collected the data of allergic patients aged 0-14 years for retrospective cross-sectional analysis to evaluate the positive rates of total IgE, HDM IgE, FS-IgE and FS-IgG4. Meanwhile, investigators screened out patients who were treated with FS-IgG4-guided elimination diets with/without probiotics for more than 3 months to clarify the role of FS-IgG4 in childhood allergic diseases by assessing the improvement of clinical symptoms before and after treatment.

Allergic diseases in children are major public health concerns due to their widespread and rising prevalence. And management of allergic diseases beyond medication, such as food management is also very important. The most classic pathway to trigger allergy is type I allergy mediated by immunoglobulin E(IgE), but the role of immunoglobulin G4(IgG4) in allergic diseases is still worth exploring.In present study, investigators have collected the data of allergic patients aged 0-14 years for retrospective cross-sectional analysis to evaluate the positive rates of total IgE, house dust mite (HDM) IgE, FS-IgE and FS-IgG4. Meanwhile, investigators screened out patients who were treated with FS-IgG4-guided diet elimination with/without probiotics for more than 3 months to clarify the role of FS-IgG4 in childhood allergic diseases by assessing the improvement of clinical symptoms before and after treatment. This retrospective study was conducted to clarify the clinical relevance of food-specific IgG4 in allergic diseases and the effect of dietary avoidance on clinical symptoms, thus making a breakthrough in the diagnosis and treatment of childhood allergies.

Eligibility Criteria:
Inclusion Criteria:

Clinical diagnosis of allergic rhinitis.

* Clinical diagnosis of asthma.
* Clinical diagnosis of conjunctivitis.
* Clinical diagnosis of urticaria.
* Clinical diagnosis of atopic dermatitis.
* Total IgE,FS-IgE, HDM-IgE and FS-IgG4 must be tested.

Exclusion Criteria:

· Autoimmune diseases.
Internet-delivered CBT for Irritable Bowel Syndrome

The aim of this study is to investigate the efficacy of a 10 week Internet-delivered CBT treatment for patients diagnosed with IBS. The patients' work with the treatment and is supported through online contact with a therapist.

Approximately 86 patients will be included in the study and randomized to either condition.

All included patients are assessed one week before the treatment starts. After 10 weeks (post treatment). Follow-up assessments are conducted at 3 and 12 months follow-up after treatment.

Patients in treatment condition are hypothesized to experience significant reduction IBS symptoms, societal costs and quality of life compared to patients on waiting list.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of IBS given by physician
* At screening fulfilling Rome III-criteria for IBS

Exclusion Criteria:

* Severe depression
* Suicidal ideation
* Presence of unexplained IBS alarm symptoms
Genomic Search for Childhood Obesity Genes-A Pilot Study

The purpose of this study is to screen a pediatric population (ages 2-8) for genes associated with childhood obesity.

The incidence of childhood obesity has been growing at an epidemic rate for the past several years, in part due to the lack of understanding of mechanisms at a molecular level. This study will screen a healthy general pediatric population age 2 to 8 for potential genes associated with childhood obesity using whole genomic gene arrays. Patients with BMI values equal to or greater than the 85th percentile will be compared to patients with a BMI below or equal to the 15th percentile. The INSIG2 gene will be specifically studied because of its identification in several populations of obese subjects. The differences in gene expression of the 2 groups will then be used to identify new genes for investigation in childhood obesity.

Eligibility Criteria:
Inclusion Criteria:

* Ages 2-8, predominately Caucasian to minimize population stratification

Exclusion Criteria:

* Chronic diseases (diabetes, cancer, etc) and known syndromes
An App to Aid in Transitioning Off Opioid Medication

The investigators propose to develop a smartphone app (called BetterOFF) that will help patients manage opioid withdrawal during opioid medication taper and detoxification. The BetterOFF smartphone intervention will be a resource patients can access anytime and anywhere. If the BetterOFF intervention were to be effective in helping patients discontinue opioid medication, it could be integrated into the standard of care of office-based clinical practices, as well as substance use programs, thereby having a substantial public health impact.

Many of the growing number of patients prescribed long-term opioid medication (for a variety of reasons including a history of illicit opioid use or management of chronic pain) will express an interest in discontinuing medication. However, many patients, physically dependent on opioids, fear the withdrawal symptoms that inevitably occur with opioid medication discontinuation and will experience a decrease in their self-efficacy for abstinence at the end of a taper. As a result, tapering is often slow and done hesitantly, and relapse rates after an opioid taper are high and associated with broad consequences, including significant negative physical, mental, and social problems. Even with optimal tapering protocols, patients need novel approaches to manage the discontinuation of opiate agonist treatment. Given this important gap in opioid treatment delivery, we propose to develop a theoretically-driven, smartphone-delivered intervention (Better Off app) to help patients effectively manage the experience of opioid medication discontinuation.

Eligibility Criteria:
Inclusion Criteria:

* between 18-65 years of age;
* currently receiving opioid medication;
* interesting in discontinuing opioid medication
* has a smartphone

Exclusion Criteria:

* non-English speaking.
Phase 1 Study of Belimumab in Subjects With Systemic Lupus Erythematosus (SLE)

The purpose of thie study is to evaluate the safety, tolerability, immunogenicity, pharmacokinetics and pharmacodynamics of belimumab (LymphoStat-B™)in subjects with SLE.


Eligibility Criteria:
Key Inclusion Criteria:

* Clinical diagnosis of SLE by ACR criteria
* Stable SLE disease activity
* On stable SLE treatment regimen
* History of measurable autoantibodies

Key Exclusion Criteria:

* Pregnant or nursing
* Received a non-FDA approved investigational agent within last 28 days
* Received cyclosporin, intravenous immunoglobulin (IVIG) or plasmapheresis within last 6 months
* Active lupus nephritis requiring hemodialysis, intravenous cyclophosphamide (Cytoxan™), or high-dose prednisone (\> 100 mg/day) within last 6 months
* Active central nervous system (CNS) lupus requiring medical intervention within last 6 months
* History of renal transplant
* History of clinical evidence of an active significant acute or chronic diseases
* Have required management or hospitalization of any infection within last 4 weeks.
* History of hypogammaglobulinemia or IgA deficiency
* Have current drug or alcohol addiction
* History of or test positive at screening for HIV, Hepatitis B or Hepatitis C
Evaluation of Sodium Fluoride PET in the Identification of Bone Metastases in Patients Having Undergone a Choline PET for Occult Recurrence of Prostatic Adenocarcinoma

The purpose is to evaluate if sodium fluoride PET in patients having already undergone a choline PET negative for bone extension (non-metastatic status) modifies the status of patients concerning the existence or not of bone metastases.

Secondary purposes are:

* To evaluate if detection of bone metastasis by sodium fluoride PET, not detected by choline PET, leads to change of treatment
* To evaluate inter-technique concordance (choline vs sodium fluoride PET) of results (metastatic status and number of lesions)
* To evaluate the inter-judge concordance of interpretation of sodium fluoride PET
* To study the discordance of metastatic status of 2 techniques.


Eligibility Criteria:
Inclusion Criteria:

* Prostate adenocarcinoma regardless of Gleason score
* Patients having undergone radical treatment (prostatectomy or radiotherapy (external or brachytherapy) +/- conco-adjuvant hormonal therapy)
* Level of Prostate Specific Antigen (PSA) indicating recurrence: PSA \> 0.2 ng/ml in case of prostatectomy (in 2 consecutive tests in less than 1 month) or elevation of PSA of at least 2 ng/ml above nadir in case of radiotherapy or brachytherapy (in 2 consecutive tests in less than 1 month)
* Negative conventional assessment (thoracic-abdominal-pelvic scanner and bone scintigraphy) during 6 weeks before inclusion
* Patient having undergone a choline PET at CHRU Nancy
* Signed informed consent
* Affiliation to French social security
* Absence of contraindications to sodium fluoride PET

Exclusion Criteria:

* Refusal or impossibility of informed consent
* Patient incapable to consent
* Patient deprived of liberty
* Person under legal protection
* Person in life-and-death emergency
* Drug addiction, alcoholism, psychological problems affecting patient compliance
* Severe co-morbidities
* Modification of hormonal therapy (if applicable) during 3 months before inclusion
* Renal insufficiency (creatinine clearance \< 60 ml/min) detected during last assessment before inclusion
* Other progressive tumors (recovered cancers are not a non-inclusion criteria)
Complications of Diabetes With Puzzles

In this study, it was aimed to investigate the effect of diabetes complications training on endocrine system diseases and nursing care in the Internal Medicine Nursing course on the knowledge level of nursing students.

Puzzles, which are among the active learning tools, are frequently preferred today because they make learning fun, are economical, improve problem-solving skills and offer understandable learning. The student\&#39;s involvement in a fun game, his effort to find the correct information, and the feedback he receives afterwards have an important place in terms of learning. It develops students\&#39; decision-making power with a critical perspective. Puzzles increase students\&#39; motivation and self-confidence by turning complex concepts into a hobby. The use of the puzzle technique in learning concepts related to theoretical knowledge is among the studies carried out in recent years. The puzzle technique is used in many fields such as pharmacology in nursing education (Shawahna \&amp; Jaber, 2020), child health and diseases (Kaynak et al., 2023), pain management (Köse Tosunöz \&amp; Deniz Doğan, 2023), teaching in nursing (Kalkan et al., 2022). It has been shown to have a positive effect on learning information. In this study, it was aimed to investigate the effect of diabetes complications training on endocrine system diseases and nursing care in the Internal Medicine Nursing course on the knowledge level of nursing students.

Eligibility Criteria:
Inclusion Criteria:

* Volunteering to participate in research
* Having course continuity

Exclusion Criteria:

* Not volunteering to participate in the research
Assessment of Clinical Consistency of Three Production Lots of GSK Biologicals' HRV Vaccine

The purpose of this study is to evaluate the lot-to-lot consistency of three production lots of GSK Biologicals' HRV vaccine in terms of immunogenicity and safety in healthy infants aged 2 months at the time of first vaccination.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study.
* A male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination.
* Written informed consent obtained from the parent or guardian of the subject.
* Free of obvious health problems as established by medical history and clinical examination before entering into the study.

Exclusion Criteria:

* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
* Child is unlikely to remain in the study area for the duration of the study.
* Previous confirmed occurrence of rotavirus gastroenteritis.
* Gastroenteritis within 7 days preceding the study vaccine administration.
* Household contact with an immunosuppressed individual or pregnant woman.
* Use of antibiotics during the period starting from 7 days before dose 1 of vaccine(s).
* Planned administration of a vaccine (other than routine pediatric vaccines) not foreseen by the study protocol during the period starting from 14 days before each dose of study vaccine(s) and ending 14 days after.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
* Any clinically significant history of chronic gastrointestinal disease including any uncorrected congenital malformation of the gastrointestinal tract or other serious medical condition as determined by the investigator.
* History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
* Major congenital defects or serious chronic illness.
* Acute disease at time of enrollment.
* Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
Multimodal Analysis of Structural Voice Disorders Based on Speech and Stroboscopic Laryngoscope Video

This study intends to collect clinical data such as strobary laryngoscope images and vowel audio data of patients with structural voice disorders and healthy individuals, and to establish a multimodal voice disorder diagnosis system model by using deep learning algorithms. Multi-classification of diseases that cause voice disorders can be applied to patients with voice disorders but undiagnosed in clinical practice, thereby assisting clinicians in diagnosing diseases and reducing misdiagnosis and missed diagnosis. In addition, some patients with voice disorders can be managed remotely through the audio diagnosis model, and better follow-up and treatment suggestions can be given to them. Remote voice therapy can alleviate the current situation of the shortage of speech therapists in remote areas of our country, and increase the number of patients who need voice therapy. opportunity. Remote voice therapy is more cost-effective, more flexible in time, and more cost-effective.

1. Detection and Classification of Acoustic Lesions Based on Speech Deep Learning
2. Detection and Classification of Acoustic Lesions Based on Deep Learning of Images
3. Detection and Classification of Acoustic Lesions Based on Deep Learning Based on Multimodality

Eligibility Criteria:
Inclusion Criteria:

Laryngeal cancer, laryngeal precancerous lesions, benign laryngeal lesions with voice disorders, healthy people without throat diseases

Exclusion Criteria:

1. A history of laryngeal surgery
2. Patients with voice disorders caused by various causes except laryngeal cancer, laryngeal precancerous lesions, and benign laryngeal lesions
3. The audio quality is not clear, the stroboscopic laryngoscope does not clearly display the anatomical area related to the glottis, and it is underexposed and blocked;