cyrilzakka/clinical-trials huggingface dataset:
Lorazepam for the Treatment of Status Epilepticus in Children

The purpose of this study is to gather the data to: 1) determine the best dose, and 2) evaluate its effectiveness and safety in stopping seizures. Part 1 is a pharmacokinetic study (study of how much drug is found in the body after it is given through a vein and how fast the body gets rid of the drug).

Lorazepam is in a class of drugs called benzodiazepines that is used to treat seizures. Lorazepam has been widely used to treat children who have repeated or long seizures, a condition known as status epilepticus (SE). However, lorazepam is not currently approved by the FDA for use in children under 18 years of age. Therefore, the purpose of this study is to gather the data needed for FDA approval. Specifically, we will 1) determine the best dose, and 2) evaluate its effectiveness and safety in stopping seizures. Part 1 is a pharmacokinetic study. These are studies designed to identify and describe one or more of the following basic pharmacological concepts in humans: absorption (i.e. how much gets into the body); distribution (i.e. where it goes in the body); and metabolism and elimination (i.e. how the body gets rid of the medication and how long it takes). The study procedures involve taking blood samples from children, taking their vital signs, and conducting physical examinations. Informed consent will be obtained from all participants as required by federal guidelines. Patients will be divided into two groups. The first group will be patients who present to one of the 10 participating Emergency Rooms (ERs) in status epilepticus (repeated or continuous seizures). We will either ask for consent in the ER, or if we know they have a seizure disorder and have frequent visits to the ER, consent them beforehand for future visits to the ER. The second group will include patients who have a known seizure disorder and agree to be electively admitted to the hospital for a dose of lorazepam when they are not having seizures. We will draw blood samples from patients for up to 48 hours and then follow up via telephone for 30 days from the day the medication was given to assess for side effects.

Eligibility Criteria:
Inclusion Criteria:

* Generalized tonic clonic seizures within 1 hour OR 2 or more generalized tonic clonic seizures in rapid succession with no recovery of consciousness between seizures OR a single ongoing generalized tonic clonic seizure which has lasted at least 5 minutes

Exclusion Criteria:

* Inability to obtain informed consent or assent
* Sustained hypotension
* Significant arrhythmia
* Known hypersensitivity to or contraindication to use of benzodiazepines
* Use of lorazepam within 4 days of study drug dosing
* American Association of Anesthesiology (ASA) Class \> 1
What Are the Ingredients for the Best Form of the Best Possible Self (BPS) Intervention?

This study aims to determine the relevant 'ingredients' to make the best possible self (BPS) intervention most efficacious and test whether the BPS's efficacy can be enhanced by including mindfulness aspects.

The best possible self (BPS) intervention is a brief positive psychology intervention to increase a person's positive affect and optimism. The BPS has been used in different forms (writing vs. imagining/visualizing vs. writing + imagining/visualizing the best possible self). However, it remains unclear which 'ingredients' are necessary to let the BPS unfold its effects. This online study aims to determine the relevant 'ingredients' to make the best possible self (BPS) intervention most efficacious. Since mindfulness interventions have recently indicated promising effects on positive and negative affect, another goal of this study is to test whether the BPS's efficacy can be enhanced by including aspects of mindfulness.

Eligibility Criteria:
Inclusion Criteria:

* fluent in the German language
* access to a computer/tablet/smartphone with audio output/headphones

Exclusion Criteria:

* not willing to take part in an online-intervention (duration: 60 minutes)
* no access to a computer/tablet/smartphone with audio output/headphones
Evaluating Radiomorphometric Indices and Fractal Dimension of the Pediatric Oncology Patients on Panoramic Images

This study evaluated pediatric oncology patients in terms of quality of bone and determine any relation between bone quality and radiotherapy/chemotherapy. The alternative hypothesis is that the bone quality of the oncology patients who received radiotherapy/chemotherapy is lower than the control group.

Cancer is the abnormal and uncontrolled proliferation of certain tissues in the body for a reason that cannot be determined yet. Childhood cancers occur between 0-17 years of age, and follow-up and treatment of these patients are performed in pediatric oncology services. Diagnosis in childhood cancers can be made by clinical examination as well as blood tests and examination of tissue samples. There are also some imaging methods used for diagnosis; ultrasonography, computed tomography, magnetic resonance imaging, positron emission tomography / computed tomography (PET / CT).

Treatment methods in childhood cancers are as follows; surgery, chemotherapy, radiotherapy and stem cell transplantation. Once diagnosed, oncologists and surgeons may choose one of these treatment options by mutual consultation or decide on a treatment method. Fractal analysis is a numerical as fractal dimension. Trabeculae are thin columns with numerous large spaces that give a honeycomb or spongy appearance of cancellous bone, which is also called trabecular bone or spongy bone. Previously, fractal analysis has been reported as a useful method to detect various diseases that affect the trabecular bone structure. Particularly in the field of dentistry, studies have shown that fractal analysis by the box-counting method can successfully evaluate trabecular changes in the mandible of patients with osteoporosis and periodontal diseases and in lactating women.

Eligibility Criteria:
Inclusion Criteria:

* to have been treated for any oncological diseases in childhood
* oncological treatment completed at least one year ago

Exclusion Criteria:

* ongoing oncological treatment
* patients who unwilling to participate to study
Evaluation of Bacterial Flora Among Operation Theatre Staff at a Tertiary Care Hospital

Health care associated infection (HCAI) is a serious health hazard as it leads to increased morbidity and mortality of patients, length of hospital stay and costs associated with increased hospital stay.

A total of 361 subjects divided into four groups were included in this study. The first group comprised of 179 doctors, the second had 31 nurses, third group had 110 OT Technicians and the fourth group included 41 subjects which included housekeeping staff and cleaners. Swabs were collected from OT staff at the time of entry and at exit from the OT. Places of swabs taken were: A) Web space, B) OT dress and C) Anterior nares.

Introduction:

Health care associated infection (HCAI) is a serious health hazard as it leads to increased morbidity and mortality of patients, length of hospital stay and costs associated with increased hospital stay. Infections from OT is well known and is well established which are often referred to as "hot zones" for emergence \& spread of microbial resistance. Contamination in an operation theatre is an important cause of HCAIs and is the third leading cause of HCAIs.

This was a prospective observational study conducted in the operation theatre of a tertiary hospital once a month randomly from April 2014 - April 2016. All Operation theatre (OT) staff were included in the study. All the patients in OT and samples from the OT air \& equipment were excluded from the study. A total of 361 subjects divided into four groups were included in this study. The first group comprised of 179 doctors, the second had 31 nurses, third group had 110 OT Technicians and the fourth group included 41 subjects which included housekeeping staff and cleaners. Swabs were collected from OT staff at the time of entry and at exit from the OT. Places of swabs taken were: A) Web space, B) OT dress and C) Anterior nares.

Eligibility Criteria:
Inclusion Criteria: All Operation Theatre staff -

Exclusion Criteria: Patients in Operation Theatre, Operating room air \& equipment

-
Brain Plasticity Underlying Acquisition of New Organizational Skills in Children-R61 Phase

Organizational, time management and planning (OTMP) skills deficits are seriously impairing features of developmental disorders, such as Attention Deficit Hyperactive Disorder (ADHD) and autism, which compromise school performance and family relations. The manualized Organizational Skills Training program (OST) was designed to target children's specific OTMP deficits. However, the brain mechanisms of treatment-induced changes remain unknown. The current study combines a training intervention with non-invasive MRI imaging in a pre-/post-design to address this question.


Eligibility Criteria:
Inclusion Criteria:

* Age at entry: age ≥ 8.0 and ≤ 11.9 years corresponding to grades 3-5
* Written assent by child and consent by parent or legal guardian
* IQ: Estimated full scale IQ ≥ 85 and language comprehension scores ≥ 80 is required as in past studies to assure that children are able to comply with specific skills training and to minimize neurobiological heterogeneity
* Organizational skills deficits defined as elevated (≥ 1SD) pre-treatment COSS Parent Total T-score and at least one COSS Parent Interference item rated as either a 3 or 4 (indicating an above-average level of impairment)
* Handedness: given the greater prevalence of non-right-handedness in neurodevelopmental disorders, we will track handedness but not exclude left-handed individuals
* Medication: To minimize variability due to medication effects, we will preferentially recruit currently unmedicated individuals (no psychoactive medications in the previous 3 months). For stimulants, we will require that dosage be stable for \>1 month before study entry and parents will be asked to consult their physician regarding discontinuation for 48 hours before evaluation, mock scanning and scanning sessions.
* Must provide adequate MRI data at baseline

Exclusion Criteria:

* Enrolled in a self-contained special education classroom or served by a 1:1 paraprofessional in their classroom
* A learning disability on Individualized Education Plan
* Absence of signed consent by parent or legal guardian
* Children who dissent regardless of parental permission
* Full scale IQ \< 85
* Participants for whom stimulant discontinuation for 48 hours prior to evaluation, mock scan and scanning sessions is deemed medically impermissible
* Children with a recent (past 6 months) or current history of neuroleptic treatment or current treatment with psychotropic medications other than stimulants
* Per history (and medical records if needed) medical illness requiring chronic current treatment
* History of intrathecal chemotherapy or focal cranial irradiation
* Premature birth (\< 32 weeks estimated gestational age or birth weight \< 1500g)
* History of leukomalacia or static encephalopathy, intracerebral hemorrhage beyond grade 2, other specific or focal neurological or metabolic disorder including epilepsy (except for resolved febrile seizures)
* History of traumatic brain injury
* Contraindication for MRI scanning (metal implants, pacemakers, metal foreign bodies or pregnancy)
Precision Cell Immunotherapy Combined With Chemotherapy in Advanced Gastric Cancer

Objectives:

To evaluate the safety and effectiveness of cell therapy using Precision Cell Immunotherapy to treat Advanced Gastric Cancer.

Eligibility:

Individuals greater than or equal to 18 years of age and less than or equal to 65 years of age who have been diagnosed with Advanced Gastric Cancer.

A total of 40 patients may be enrolled over a period of 1-2 years.

Eligibility Criteria:
Inclusion Criteria:

* Age 18\~65 years old, male or female;
* Life expectancy≥6 months;
* ECOG score: 0-3;
* Advanced Malignancies (gastric cancer) were diagnosed by pathological or clinical physicians;
* Enough venous channel, no other contraindications to the separation and collection of white blood cells;
* Laboratory examination: white blood cell≥3 x 10\*9/L, blood platelet count≥60 x 10\*/L, hemoglobin≥85g/L; lymphocyte count≥15%, total bilirubin≤100 mol/L; ALT and AST less than five times of the normal level; serum creatinine less than 1.5 times of the normal level;
* Signed informed consent;
* Women of child-bearing age must have evidence of negative pregnancy test and be willing to practice birth control after 2 weeks following the cells transfusion.

Exclusion Criteria:

* Expected Overall survival \< 6 months;
* Patients with uncontrolled hypertension (\>160/95mmHg), unstable coronary disease (uncontrolled arrhythmias, unstable angina, decompensated congestive heart failure (\> Class II, NYHA), or myocardial infarction within 6 months;
* Other serious diseases: nervous, mental disorders, immune regulatory diseases, metabolic diseases, infectious diseases, etc;
* Other drugs, or other biological treatment,chemotherapy or radiotherapy are performed within a month;
* Unable or unwilling to provide informed consent, or fail to comply with the test requirements.
Compliance and Tolerance to Oral AntiBiotherapy in Osteoarticular Infections (OTABIO)

Bone and joint infections (BJI) are most often bacterial infections that can occur after surgery or de novo. They are rarely fatal in the short term, but are associated with significant morbidity, impaired quality of life and significant costs. Treatment of BJI is based on antibiotic therapy, often combined with surgery. Antibiotic therapy, at high doses, lasts a minimum of 6 weeks. It can be responsible for severe adverse effects. These characteristics (prolonged duration, multiple daily doses, and adverse effects) are known to negatively affect treatment adherence in general.


Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years
* Diagnosis of osteoarticular infection
* Treatment with at least one oral antibiotic for a minimum expected duration ≥ 6 weeks with an expected end of treatment date
* Patient who was informed and did not object to participate in the study

Exclusion Criteria:

* Treatment for BJI with oral antibiotic without end of treatment date
* treatment for BJI with parenteral antibiotic only
* patient who doesn't have a telephone number or who doesn't want to give it
* Adults subject to a legal protection measure
* Pregnant or breastfeeding women
Building Blocks for Healthy Preschoolers

Pediatric obesity, a defining health problem of the century, leads to long-term health disparities. This application evaluates strategies to prevent health disparities early in life by developing environmental wellness-related interventions focused on child-care center staff and families.

Childcare centers provide an excellent opportunity to build healthy dietary and physical activity lifestyle habits and avoid the rapid weight gain that leads to health disparities. Building on a statewide survey among childcare centers and a pilot evaluation of an environmental intervention, this 3-cell randomized trial evaluates the impact of a staff-led wellness intervention and a staff-led and family-focused intervention, against a control condition.

The intervention trial will be conducted in 48-55 childcare centers throughout Maryland, enrolling 864 children age 30-54 months from childcare centers serving low-income families. The aims are:

1. to examine the impact of the wellness intervention individually and combined with the family intervention versus control on BMI z-score, food preferences and knowledge, and physical activity among children
2. to examine the sustainability of the interventions
3. to examine whether changes in outcomes measures for children's BMI z-score, gross motor skills, food preferences and knowledge, and physical activity are mediated by changes in the childcare staff wellness-related attitudes and behaviors and/or parent wellness-related attitudes and behaviors (exploratory).

Findings from the trial will inform programs and policies in childcare centers to prevent obesity and reduce disparities, and will be disseminated locally, regionally, and nationally through conferences, information briefs, social media, and peer-reviewed journal articles. The overall objective is to promote statewide strategies that reduce pediatric obesity and the long-term health disparities.

Eligibility Criteria:
Inclusion Criteria:

* Preschooler 30-54 months
* Caregiver and childcare staff must be at least 18 years old
* Childcare center staff members willing to participate
* Licensed childcare centers serving low-income communities
* Children attending participating childcare centers (at least 3 days per week)

Exclusion Criteria:

* Caregivers and staff who do not speak or read English
* Childcare staff and preschoolers with health problems that would interfere with participation in physical activities
First-in-human Study of BAY2287411 Injection, a Thorium-227 Labeled Antibody-chelator Conjugate, in Patients With Tumors Known to Express Mesothelin

The purpose of this study is to evaluate, in patients with tumors known to express the protein mesothelin, the following properties of BAY2287411 injection:

* safety (to identify, assess, minimize, and appropriately manage the risks associated to the study drug)
* tolerability (the degree to which side effects can be tolerated by your body)
* maximum tolerated dose
* pharmacokinetics (the effect of your body on the study drug)
* anti-tumor activity
* recommended dose for further clinical development


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* Male or female subjects ≥ 18 years of age
* ECOG PS (Eastern Cooperative Oncology Group Performance Status) of 0 or 1
* Patients with advanced malignant epithelioid mesothelioma or advanced recurrent serous ovarian cancer, who have exhausted available therapeutic options; in addition, in the dose expansion part of the study, patients with metastatic pancreatic adenocarcinoma, who have exhausted available therapeutic options
* Availability of fresh or archival tumor tissue samples
* Adequate bone marrow, liver and renal function, as assessed by pre-defined laboratory requirements (within 28 days before start of study drug treatment)
* A negative serum pregnancy test in women of childbearing potential (WOCBP) performed within 7 days before the start of study drug administration. Women and men of reproductive potential must agree to use highly effective methods of contraception, when sexually active.

Exclusion Criteria:

* Impaired cardiac function, clinically significant cardiac disease or cardiac arrhythmias
* Pericarditis (any CTCAE grade) or pericardial effusion (CTCAE Grade ≥ 2)
* Left Ventricular Ejection Fraction (LVEF) \< 50% (as measured at screening by echocardiogram).
* History of anaphylactic reactions to monoclonal antibody therapy
* History of Myelodysplastic syndrome (MDS)/treatment-related acute myeloid leukemia (t-AML) or with features suggestive of MDS/AML
* Infections of CTCAE (Common Terminology Criteria for Adverse Events) version 5.0 Grade 2 not responding to therapy or active clinically serious infections of CTCAE Grade \>2; known human immunodeficiency virus (HIV) infection; active hepatitis B virus (HBV) or hepatitis C virus (HCV)infection requiring treatment. Patients with chronic HBV or HCV infection are eligible at the investigator's discretion provided that the disease is stable and sufficiently controlled under treatment
* Known brain, spinal or meningeal metastases
Recurrence Patterns and Cost-Effectiveness of Surgical Approaches in Early-Stage Hepatocellular Carcinoma

This study aims to investigate the recurrence patterns and cost-effectiveness of robotic-assisted, laparoscopic, and open liver resections in patients with early-stage (BCLC 0/A) hepatocellular carcinoma. By analyzing data from 3000 patients across 27 centers, the research evaluates recurrence-free survival, overall survival, and long-term economic impacts using metrics such as quality-adjusted life years (QALYs) and incremental cost-effectiveness ratios (ICERs). Findings will provide insights into optimal surgical approaches to improve patient outcomes and healthcare resource utilization.


Eligibility Criteria:
Inclusion Criteria:

* (1) HCC diagnosis confirmed by two independent radiologists using contrast-enhanced computed tomography (CT) and/or magnetic resonance imaging (MRI) combined with postoperative pathology; (2) BCLC stage 0 or A; and (3) curative liver resection

Exclusion Criteria:

* (1) concurrent malignancies in other organs; (2) diagnosis of combined hepatocellular-cholangiocarcinoma; (3) prior neoadjuvant or adjuvant treatment before liver resection; (4) recurrent HCC; (5) ruptured HCC; and (6) incomplete follow-up or missing data.
Evaluation of Fiasp® (Fast Acting Insulin Aspart) in 670G Hybrid Closed-Loop Therapy

This is a pilot outpatient study conducted at Stanford to obtain preliminary data on how Fiasp® works in a closed-loop system and to determine if any changes need to be made to the 670G pump to optimize the use of Fiasp®.

This will be a randomized cross-over blinded study and to see how the 670G pump responds to the introduction of Fiasp® insulin. Subjects enrolled in the study will have a 2 week period of optimization with weekly assessments of their Carelink download before entering the blinded phase of the study. They will use their usual home insulin during the optimization phase. They will then be started on their first blinded insulin (aspart or Fiasp®) which they will use for 2 weeks, before they cross-over to the other insulin.

Eligibility Criteria:
Inclusion Criteria:

1. Clinical diagnosis of type 1 diabetes and using 670G pump for at least 1 month, and willing to have the 670G pump downloaded into a Carelink Clinical research database.
2. The diagnosis of type 1 diabetes is based on the investigator's judgment; C-peptide level and antibody determinations are not needed.
3. Age ≥18 years
4. Using Novolog or Fiasp® insulin at time of enrollment
5. Willing to use Fiasp® insulin
6. Total daily insulin dose is at least 0.3 units/kg/day
7. Usual carbohydrate intake is at least 60 grams a day, and willing to have at least 25 grams of carbohydrates for breakfast
8. For females, not currently known to be pregnant
9. An understanding of and willingness to follow the protocol and sign the informed consent
10. Willing to have photographs taken of their infusion sites
11. Willing to download their 670G pump every 1-2 weeks to a research Carelink account
12. Willingness to answer a brief online questionnaire every 2 weeks
13. Must be able to understand spoken or written English
14. For subjects participating in Part 2 of this study they will need to be using Fiasp® as part of their usual care
15. Hemoglobin A1c between 6 and 10% at the time of enrollment

Exclusion Criteria:

1. Pregnant or lactating females
2. No hypoglycemic seizure or loss of consciousness in the past 6 months
3. Severe episode of DKA in the 6 months prior to study enrollment that was unrelated to an infusion set failure
4. No known cardiovascular events in the last 6 months
5. No active proliferative diabetic retinopathy
6. Known tape allergies
7. Current treatment for a seizure disorder
8. Cystic fibrosis
9. Active infection
10. A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol
11. Inpatient psychiatric treatment in the past 6 months
12. Presence of a known adrenal disorder
13. If on antihypertensive, thyroid, anti-depressant or lipid lowering medication, with lack of stability on the medication for the past 2 months prior to enrollment in the study
14. Abuse of alcohol
15. Dialysis or renal failure
16. Known eGFR \<60%

Note: Adequately treated thyroid disease and celiac disease do not exclude subjects from enrollment.