cyrilzakka/clinical-trials huggingface dataset:
Maximizing the Reach of Universal Child Sexual Abuse Prevention: An Equivalence Trial

The goal of this clinical trial is to test the equivalence of two delivery modalities of a universal child sexual abuse prevention program, Safe Touches: usual vs. modified. The aims are to:

1. Determine the equivalence of effectiveness between usual and modified Safe Touches
2. Assess the maintenance of gains between usual and modified Safe Touches
3. Examine factors that may impact the future dissemination and implementation

Child sexual abuse (CSA) is a public health problem affecting 1 in 5 girls and 1 in 12 boys before age 18. National estimates indicate children ages 7 to 13 are at highest risk for CSA and CSA is associated with lifelong negative sequelae. School-based prevention programs offer cost-effective universal programming teaching students an array of personal safety skills. Several programs have demonstrated effectiveness in increasing children's knowledge of self-protection, and some have been linked with facilitating disclosures, including Safe Touches. Effectiveness notwithstanding, the programmatic reach of universal school-based programs is limited by the inherent reliance on school infrastructure and a dearth of available alternative delivery modalities. The current study is designed to address this gap by leveraging an existing partnership between university-based researchers (NYU), the Safe Touches model developer (NYSPCC), and community-based organizations with active implementations of Safe Touches. The study will use a rigorous cluster randomized design to determine the equivalence of effectiveness between two delivery modalities of Safe Touches: as usual vs. modified. The usual workshop will be delivered by two facilitators with live puppet skits, as designed (N=90). Whereas, the modified workshop will be delivered by one facilitator utilizing pre recorded skit videos (N=90). The research team will determine the equivalence of concept learning acquisition (Aim 1) and retention (Aim 2) among students in classrooms that receive the as usual or modified workshop. To conclude equivalence, it is important to examine factors that may impact future dissemination and implementation, specifically program adoption among school personnel and implementation fidelity (Aim 3). Study findings will inform the ongoing development of effective CSA prevention programs and policy decisions regarding the sustainable integration of such programs within schools. Given the scope and burden of CSA, especially among elementary aged students, it is a public health priority to efficiently disseminate effective school-based prevention programs on a wide scale.

Eligibility Criteria:
Inclusion Criteria:

* Enrolled in a second grade classroom participating in the research
* Native English speaker
* Parental permission to participate in the research

Exclusion Criteria:

* Not enrolled in a second grade classroom participating in the research
* Non-native English speaker
* No parental permission to participate in the research
The Efficacy of SPSIPB on Postoperative Pain and Analgesic Consumption in Patients Undergoing VATS

The aim of this study is to investigate the postoperative analgesic efficacy of SPSIPB and its effect on opioid consumption in patients undergoing video-assisted thoracoscopic surgery (VATS).

There were two randomized groups: Group S (SPSIPB) (n=12), Group C (no block) (n=12). All patients had standard general anesthesia. Group S had serratus posterior superior intercostal plane block (SPSIPB) with 0.25% bupivacaine (total volume of 30 ml) at the end of the surgery. Group Control had only tramadol for postoperative pain. Numerical rating scale (NRS) was used to assess postoperative pain on 1st, 6th, 12th and 24th hour after the surgery. Total tramadol consumption was calculated using patient-controlled analgesia (PCA) device.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients older than 18 years of age who underwent video-assisted thoracoscopic surgery (VATS) under general anesthesia and were American Society of Anesthesiologists (ASA) I-II-III according to the ASA risk classification.

Exclusion Criteria:

* Patients who did not give consent,
* patients with coagulopathy,
* patients with signs of infection at the block application site,
* patients using anticoagulants,
* patients with local anesthetic drug allergies,
* patients undergoing open surgery,
* patients with unstable hemodynamics,
* patients who could not cooperate during postoperative pain assessment
A Study to Investigate the Regional Brain Kinetics of Brain Drug Transporters Using P-glycoprotein and Breast Cancer Resistance Protein Substrates and by Using the Positron Emission Tomography Ligand 11C-JNJ-63779586 in the Human Brain

The purpose of this study is to investigate the total body biodistribution and radiation dosimetry of 11C-JNJ-63779586 by Positron Emission Tomography (PET) in healthy young adult males (Part A); to estimate and compare the uptake, distribution, and clearance of 11C-JNJ-63779586 in the brain by PET between mild Alzheimer Disease (AD) participants (males/females) and age- and gender-matched control participants (Part B), corrected for regional cerebral blood flow differences; and to model the tissue specific kinetics of 11C-JNJ-63779586 in human brain with the appropriate input function (IF) (Part B).


Eligibility Criteria:
Inclusion Criteria:

Part A

* Healthy men between 18 and 55 years of age, inclusive
* Body mass index (BMI) between 18 and 30 kilogram per meter square (kg/m\^2) ², inclusive, and a body weight of not less than 50 kilogram (kg) Part B
* Men or women with mild Alzheimer's Disease (AD), age- and gender-matched control participants, between 55 and 85 years of age, inclusive
* BMI between 18 and 35 kg/m\^2, inclusive, and a body weight of not less than 50 kg
* Mild AD participants will be amyloid positive and have a mini-mental state examination (MMSE) greater than or equal to (\>=) 20. The matched control participants will be amyloid negative and have a MMSE \>= 26, respectively

Exclusion Criteria:

* History of or current clinically significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematologic disease, coagulation disorders (including any abnormal bleeding or blood dyscrasias), lipid abnormalities, significant pulmonary disease, including bronchospastic respiratory disease, diabetes mellitus, hepatic or renal insufficiency (estimated glomerular filtration rate \[eGFR\] within the screening period of less than 60 milliLitre per minute per 1.73 meter square \[mL/min/1.73 m\^2\], thyroid disease, neurologic or psychiatric disease, infection, or any other illness that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results
* Clinically significant abnormal values for hematology, clinical chemistry, or urinalysis at screening or at admission to the study center as deemed appropriate by the investigator
* Participant has a clinically relevant abnormal physical- or neurological examination, vital signs or 12-lead electrocardiogram (ECG)
* Participant has a history of epilepsy or fits or unexplained black-outs other than vasovagal collapse within 10 years before screening
* Participant has past or planned exposure to ionizing radiation that in combination with the planned administration with the study Positron Emission Tomography (PET) ligand and Computerized Tomography (CT) scan would result in a cumulative exposure that exceeds local recommended exposure limits
Observational Multicenter Non-interventional Study on COPD Patients Treatment Strategies at the Time of Hospital Discharge and Within 12 Months of Follow-up on an Outpatient Primary Care Basement

The study is an observational multicenter descriptive study. It is planned to enroll approximately 1250 subjects with severe and very severe COPD hospitalized for the reason of COPD exacerbation into departments of pulmonology or therapy. The study will be conducted in approximately 20-25 institutions of treatment and prevention in Russian Federation and will include about 50 to 60 subject at each clinical site.

The study is an observational multicenter descriptive study. It is planned to enroll approximately 1000 subjects with severe and very severe COPD hospitalized for the reason of COPD exacerbation into departments of pulmonology or therapy. The study will be conducted in approximately 20-25 institutions of treatment and prevention in Russian Federation and will include about 50 to 60 subject at each clinical site.

This is an observational study, so there is no treatment protocol or subjects' management recommendations required. The study subjects receive medical treatment according to the routine practice for their disease in Russian Federation. A subject's participation in this clinical study should not affect character and amount of care provided according to the routine clinical practice.

The study includes 5 clinical visits: Study Enrolment Visit, Month 3 Visit, Month 6 visit, Month 9 Visit, Month 12 visit / End of Study Visit.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent . Men and women at least 40 years old, with smoking history more than 10 pack-years.
* Hospitalization for the reason of COPD exacerbation (exacerbation defined as acute condition, different from typical fluctuations of general condition and requiring change of therapy).
* Diagnosis of severe or very severe COPD based on final spirometry (performed in a standardized manner using salbutamol 400 mg), or history of diagnosis of severe or very severe COPD based on spirometry performed during 6 months before the hospitalization.

Exclusion Criteria:

* Participation in any interventional study.
* Concomitant respiratory diseases, i.e. confirmed or suspected malignancy or any other serious condition, including lung tumor, lung fibrosis, interstitial lung disease, tuberculosis, sarcoidosis.
* Patient is unable or unwilling to complete questionnaires, unable to understand study procedures, or other reasons which, in the investigator's opinion, could affect study procedures performance.
Prophylactic Antiemetic Efficacy of Palonosetron Versus Ondansetron for Cesarean Sections Under Regional Anesthesia

This study aims to compare the quality of perioperative antiemesis of palonosetron and ondansetron in patients undergoing cesarean section

Perioperative nausea and vomiting (PONV) related to spinal block anesthesia are common events and unpleasant for pregnant women. Its incidence can reach 80% in high-risk patients, and remains high despite the emergence of new antiemetic drugs.

Episodes untreated can result in prolonged stay in post-anesthetic care unit (PACU) and rehospitalization which can result in significant increase in overall costs of health care.

The purpose of the prophylaxis of PONV is therefore decrease its incidence, the stress of the patient, improve the quality and safety of surgical procedure and reduce hospital costs.

Antagonists of the 5-hydroxytryptamine 3 subtype receptor have been widely used and effective against PONV due to its efficacy and a favorable side-effect profile. Palonosetron is a new and potent drug generation5 second-HT antagonist with improved profile that acts longer. Recent studies where it was compared to ondansetron and palonosetron in high-risk patients in head and neck surgery and laparoscopic surgery is disclosed palonosetron far superior to ondansetron especially 2-24 hours after surgery. But there are no studies on caesareans comparing the two drugs.

This prospective, randomized, double-blind, placebo controlled, was designed to evaluate the efficacy of palonosetron compared with ondansetron and placebo for the prevention of nausea and vomiting in patients undergoing cesarean delivery under spinal anesthesia.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists class I or II
* Scheduled for cesarean section on Maternal and Child Hospital of Brasilia, Federal District, Brazil

Exclusion Criteria:

* patients who had received antiemetics, diabetic, allergic to any study drug, corticosteroid use, psychoactive drugs, patients with vomiting in the course of gastrointestinal disease, eclampsia, heart disease, smokers, any evidence of fetal distress, psychiatric disease or who refused to participate.
Investigational Imaging Technique During Brain Surgery

This early phase I trial tests the safety and reliability of an investigational imaging technique called quantitative oblique back illumination microscopy (qOBM) during brain surgery for detecting brain tumors and brain tumor margins in patients with glioblastoma, astrocytoma, or oligodendroglioma. Surgical margins refer to the edge or border of the tissue removed in cancer surgery. qOBM may be able to assess and reveal brain tumor surgical margins in a more safe and reliable manner.

PRIMARY OBJECTIVE:

I. To perform a first-in-human study to assess the ability of a quantitative oblique back illumination microscopy (qOBM) handheld device to safely and reliably image brain tumor pathology intraoperatively in-situ and in-vivo.

SECONDARY OBJECTIVES:

I. To characterize the biophysical and structural features that enable detection of bulk tumor and tumor margins, including infiltrative disease, with qOBM.

II. To develop qOBM imaging probes with multimodal capabilities (analog black and white and color imaging, fluorescent imaging) and with the potential to clearly reveal brain tumor margins ex vivo and in vivo during neurosurgical procedures.

OUTLINE:

Patients undergo craniotomy with intraoperative ex vivo and in situ tumor assessment with qOBM. Patients then undergo postoperative exam with computed tomography (CT) or magnetic resonance imaging (MRI) any of days 1-5 after surgery.

Eligibility Criteria:
Inclusion Criteria:

* Age \>= 18 years
* Craniotomy is indicated for tumor management
* Surgery planned for 14 or fewer days from enrollment
* Evidence of a personally signed informed consent indicating that the subject is aware of the neoplastic nature of the disease and has been informed of the procedures to be followed, the experimental nature of the device evaluation, alternatives, potential risks and discomforts, potential benefits, and other pertinent aspects of study participation.
* A newly discovered brain lesion requiring surgery who imaging is consistent with a new glioblastoma, astrocytoma, or oligodendroglioma or with a progressive histologically proven glioblastoma, astrocytoma, or oligodendroglioma whose management required surgery.

Exclusion Criteria:

An individual who meets any of the following criteria will be excluded from participation in this study:

* Patients who are undergoing needle biopsy only
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Lumbar Spinal Fibrosis and TNF Alpha Inhibition

TNF-alpha is the main cytokine implicated in the formation of lumbar spinal fibrosis. Inhibiting TNF-alpha could significantly decrease spinal fibrosis after lumbar discectomy.

OBJECT:

Failed back surgery syndrome is still a challenging therapeutic problem. Clinical studies have demonstrated a significant association between lumbar spinal fibrosis after lumbar discectomy and the recurrence of radicular pain in 25% of cases. Forceful epidural infiltrations, radiotherapy, therapy with D-penicillamine or surgical procedures have had unfavourable results in terms of pain and cost. Magnetic resonance imaging reveals lumbar spinal fibrosis by a hyposignal in the T1 sequence and a hypersignal in T2 sequence around the spinal tissue. Tumor necrosis factor a (TNF-a) is the main cytokine implicated in the formation of tissue fibrosis. In animal models of fibrosis, TNF-a inhibition has been shown to prevent and treat tissue fibrosis.

HYPOTHESIS:

Inhibiting TNF-a could significantly decrease sciatica pain because of lumbar spinal fibrosis after lumbar discectomy by decreasing spinal fibrosis.

METHODS:

We propose a 2-year pilot prospective, randomized, double-blind, controlled study of TNF-a inhibitor (infliximab) in patients with sciatica as a result of postoperative lumbar spinal fibrosis. The infliximab group will receive one intravenous injection of 3 mg/kg infliximab. The control group will receive one physiological serum injection. Patients will be evaluated at day 0, 10, 30, 90, and 180. The main evaluation criterion will be sciatica pain as measured on a visual analog scale, with the objective of a 50% decrease in pain at day 10. This objective leads to a size of 20 patients per group. The other evaluation criteria will be clinical, functional, social, and professional. Patients will be recruited from the rehabilitation unit at Cochin teaching hospital.

Eligibility Criteria:
Inclusion Criteria:

* age over 18 years old
* sciatica post discectomy
* Pain with VAS \> 40 mm and impossibility to have his usual activity
* Surgical discectomy (less than 2 years and more than 6 months)
* Painless of more than one month and less than one year after the discectomy
* MRI with gadolinium injection of less than 6 months and done more than 6 months after the discectomy
* Presence of spinal fibrosis on MRI (hyposignal in T1 enhanced by gadolinium and hypersignal in T2)
* failure of epidural injection treatment
* absence of tuberculosis
* contraception for woman
* informed consent

Exclusion Criteria:

* Chronic psychiatric pathologies not treated
* Presence of conflict between nerve root and herniated disc or disc fragments or spinal stenosis
* severe cognitives troubles
* severe cardiac failure (class III or IV)
* Tuberculosis (active or latent), severe infections
* Cancers
* Allergy reactions to the drug studied
* Difficulties to understand french
* Patients enrolled in another clinical trial in the past three months
* pregnancy, breastfeeding or no contraception
COVID-19 and Cancer Patients

Routinely collected data will be used to assess the morbidity and mortality of cancer patients following a positive COVID-19 infection.

The SARS-CoV-2, (COVID-19) virus of the coronavirus family is believed to have been transmitted from animal to human. On 12th March 2020, the World Health Organisation (WHO) declared this particular coronavirus outbreak a pandemic.

How COVID-19 affects people is still not widely understood. Some people who have tested positive for the virus have been asymptomatic while others, who were otherwise well and healthy before infection, have died. Currently, information obtained so far suggests that most COVID-19 illness, however older people and people with severe comorbidities such as heart and lung disease and diabetes, seem to be at higher risk of developing serious COVID-19 illness.

This research is a retrospective, non-interventional study whose aim is to describe the features of COVID-19 infection specifically in cancer patients; to investigate its severity in this particular population and evaluate the long-term outcomes by means of medical charts review of consecutive patients co-diagnosed with SARS-CoV-2 infection and malignancy.

Patients will be identified from electronic medical records and entered into a pre-designed database. All information used will have been previously collected as part of routine standard of care and will involve but is not limited to: blood test results, prior and current anti-cancer therapy, medical history and most importantly clinical outcomes, such as response to any treatment provided for COVID-19 and patients' survival in relation to baseline clinic-pathologic profile. All data will be collected by each patient's team and will be anonymised and stored in a password-protected NHS computer.

Eligibility Criteria:
Inclusion Criteria:

The investigators will evaluate and include consecutive patients observed in the outpatients and inpatients facility of the study centre meeting all the following CRITERIA:

1. Be ≥18 years of age.
2. Have a confirmed diagnosis of malignancy of any type.
3. Have a confirmed diagnosis of SARS-CoV-2 infection.

Exclusion Criteria:

Patients will not be entered in the study database when one or more of the following CRITERIA are present:

1. Unconfirmed diagnosis of SARS-CoV-2 infection
2. Insufficient clinical/follow up data.
A Study on the Prevalence of Clinically Useful Mutations in Solid Tumor Characterized by Next Generation Sequencing Methods on Liquid Biopsy Analysis (POPCORN)

The implementation of liquid biopsy in clinical practice has been favored by the rapid development of genome sequencing techniques designed to analyze mutations in ctDNA. Among these, the Next generation sequencing (NGS) is a technique that consists in sequencing several genomes in a short time span, collecting information about a wider range of genomic alterations, using small quantities of genetic material. It is used to identify potential circulating dynamic biomarkers of treatment sensitivity or resistance in a real word multi-pathology evaluation. In this way, defining the mutational status of clinical relevance genes in real world, as a predictive biomarker to identify those patients most likely to benefit from target therapy, offers the potential to optimize access to further therapies. The aim of this study is to evaluate the real-world prevalence of clinically useful mutations in patients who are receiving therapy for advanced and locally advanced solid tumor through liquid biopsy.


Eligibility Criteria:
Inclusion Criteria:

Patients eligible for inclusion in this study have to meet all of the following criteria:

* Patients, 18 years of age or older
* Competent and able to comprehend, sign and date an Ethics Committee (EC) approved Informed Consent Form (ICF) before performance of any study-specific procedures or tests
* Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures
* Histologically proven diagnosis solid tumor
* Diagnosis of advanced or locally advanced disease
* Patients candidated to receive standard therapy in the following line:
* first, second or third-line therapy for colon-rectal cancer in IV stage
* first or second-line therapy for gastric cancer in IV stage
* primary intent or first-line therapy for pancreatic cancer
* first-line therapy for bile duct cancer
* first or second-line therapy for hepatocarcinoma
* first, second, third, fourth or fifth-line therapy for breast cancer in IV stage
* chemotherapy for ovarian cancer in advanced stage (FIGO III-IV) and at the time of first relapse
* first or second-line therapy for endometrial cancer in advanced stage (FIGO III-IV)
* first or second-line therapy for advanced or locally advanced cervical cancer
* therapy for locally advanced or first line therapy for metastatic vulva cancer
* first, second or third-line therapy for melanoma (third-line therapy only in BRAF-mutated melanoma)

Exclusion Criteria:

* Diagnosis of any secondary malignancy within the last 3 years, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix.
* Patients unable or unwilling to undergo as per protocol assessments at the four planned timepoints