cyrilzakka/clinical-trials huggingface dataset:
CeVUS With Intravesical Administration of OPTISON TM (Trademark) in Children

In this clinical trial the investigators aim to evaluate the diagnostic feasibility and safety of ceVUS with the intravesical use of OPTISON for vesicoureteral reflux detection and urethral imaging in children.

Contrast enhanced Voiding Urosonography (ceVUS) is a radiation free, highly sensitive imaging modality for vesicoureteral reflux (VUR) and urethral imaging in children. It employs ultrasound technology in combination with ultrasound contrast agent, which is administered intravesically via a bladder catheter. Currently, second generation ultrasound contrast agents are commercially available, comprising of gas-filled microbubbles. CeVUS in children is being widely practiced, primarily in Europe, despite the fact that none of the commercially available ultrasound contrast agents are yet approved for clinical applications in pediatric population. In the United States, there is limited clinical experience with ceVUS in children. Among the currently commercially available ultrasound contrast agents, OPTISON has already been used in research and off-label in clinical settings involving adults and children. One in-vitro study has been conducted aiming to optimize the ultrasound technical parameters and the dose of OPTISON for intravesical administration in children. In this clinical trial the investigators aim to evaluate the diagnostic feasibility and safety of ceVUS with the intravesical use of OPTISON for vesicoureteral reflux detection and urethral imaging in children.

Eligibility Criteria:
Inclusion criteria:

1. Children 2-18 years (first age cohort).
2. Children 0-18 years (second age cohort).
3. Referred to the Children's Hospital of Philadelphia (CHOP) for the performance of the clinically indicated Voiding Cystourethrography (VCUG) examination.
4. Parental/guardian permission (informed consent) and if appropriate, child's assent for additional performance of contrast enhanced Voiding Urosonography (ceVUS) examination.

Exclusion criteria:

1. Hypersensitivity to perflutren, blood, blood products or albumin.
2. Children requiring sedation for VCUG or ceVUS examinations.
3. Parents/guardians or subjects who, in the opinion of the principal investigator, may be non-compliant with study schedules or procedures.
Assessment of New Blood Culture Methods on the Microbiological Documentation of Febrile Neutropenia

Febrile neutropenia are microbiologically documented in only 30% of the cases, and almost exclusively by blood cultures. The reasons for this low documentation are likely multiple: (1) some of these fevers are of non-infectious origin. (2) The bacterial inoculum present in the blood may be low and consequently undetectable by conventional blood cultures.

The primary objective of the study is to assess new blood culture procedures and technics, in order to improve the diagnostic yield of blood cultures during febrile neutropenic episodes.

Evaluation criteria are 1) proportion of microbiologically documented infections 2) time elapsed from bed side sampling to microbiological diagnostic, in case of positive sample.

The assessed procedures included a large volume of blood, an early incubation made possible by the availability of a culture device in the hematology department, an early warning in case of positive blood culture, bacterial DNA detection in blood, and an early identification of the positive strains and their resistance profile.

We hypothesize that the combination of these different procedures will improve the proportion of microbiologically blood culture from 30 to 45%. One hundred and 20 episodes of febrile neutropenia are necessary to achieve this goal.

Eligibility Criteria:
Inclusion Criteria:

* age \> 18 y
* first episode of febrile neutropenia during a given neutropenic phase
* PMN \< 500/mm3, chemotherapy-induced
* fever \> 38°C twice, or \< 38°3C once
* signed informed consent

Exclusion Criteria:

- patient already receiving empirical or therapeutic antibacterial after their first episode of febrile neutropenia
Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects -2

The primary objective was to evaluate the effect of 12 weeks of subcutaneous (SC) evolocumab every 2 weeks (Q2W) and monthly (QM), compared with ezetimibe, on percent change from baseline in low-density lipoprotein cholesterol (LDL-C) in hypercholesterolemic adults unable to tolerate an effective dose of a statin (HMG-CoA (5-hydroxy-3-methylglutaryl-coenzyme A) reductase inhibitors).


Eligibility Criteria:
Inclusion Criteria:

* Male or female ≥ 18 to ≤ 80 years of age
* Not on a statin or on a low dose statin with stable dose for at least 4 weeks
* History of intolerance to at least 2 statins
* Subject not at LDL-C goal
* Lipid lowering therapy has been stable prior to enrolment for at least 4 weeks.
* Fasting triglycerides ≤ 400 mg/dL

Exclusion Criteria:

* New York Heart Association (NYHA) III or IV heart failure
* Uncontrolled cardiac arrhythmia
* Uncontrolled hypertension
* Type 1 diabetes, poorly controlled type 2 diabetes
* Uncontrolled hypothyroidism or hyperthyroidism
Preventing Heart Disease in Underserved Patients

The study will evaluate the impact of an internet based telemedicine system on cardiovascular risk profile of underserved patient populations. It is our hypothesis that a treatment plan and frequent communication via an internet based Telemedicine system will improve the cardiovascular risk profile of underserved patient populations at increased risk for cardiovascular disease. Our primary endpoint is a reduction over one year in the 10-year CVD risk score (ATP III risk model).

The Insight Telehealth system (ITSMyHealthfile) is a disease-managment interactive health care delivery system. Patients access the system through a special Web site using a password. The system prompts the patient to enter their weight, blood pressure and heart rate and there is a text box available for unstructed comments.

Patients will be randomized to either the telemedicine group or usual care group (controls). Individuals in the telemedicine group will be asked to transmit their health status weekly. Both groups will be followed for one year with quarterly visits.

Patients of either sex, of any ethnic background or race, between 22 and 85years of age, who have a 10% or greater 10-year risk of CVD based on the Framingham risk score, and risk factors that if properly treated would reduced the risk by 5% or greater will be eligible for the study.

Additional criteria

* literate
* telephone access
* ablility to utilize the Internet and telemedicine system (after training) Primary Outcome Reduction in Framingham risk index

Eligibility Criteria:
Inclusion Criteria:

* Framingham risk score equal to or greater than 10%
* literacy
* 22 -85 years of age
* access to phone

  * ability to use Internet and system following training

Exclusion Criteria:

* Class 3 and 4 heart failure
* ESRD
* stroke with residual disability or dementia
* unable to read or write
Data Analysis for Drug Repurposing for Effective Alzheimer's Medicines (DREAM)- Semaglutide v DPP4 Inhibitors

This study aims to evaluate the comparative risk of dementia/Alzheimer's disease onset between patients treated with medications that target specific metabolic pathways and patients treated with alternative medications for the same indication.

This is a non-randomized, non-interventional study that is part of the DREAM Study of Brigham and Women's Hospital. DREAM is led by Dr. Madhav Thambisetty, MD, PhD, Chief of the Clinical and Translational Neuroscience Section, Laboratory of Behavioral Neuroscience, National Institute on Aging (NIA) intramural research program. This study aims to evaluate the comparative risk of dementia/Alzheimer's disease onset between patients treated with medications that target specific metabolic pathways and patients treated with alternative medications for the same indication using healthcare claims data.

Eligibility Criteria:
Please see https://drive.google.com/drive/folders/1VRjPaaelXFyBbA5gV6pwB_ijSIMyIJ4N?usp=share_link or Appendix A(https://drive.google.com/drive/folders/1OgKQlxsJi9UWRDd3Kbaux_8adngoSnZY?usp=sharing) for full code and algorithm definitions.

Medicare timeframe: 2008 to 2019 (end of data availability).

Inclusion Criteria:

* 1. Aged \>/= 65 years on the index date
* 2. Enrollment in Medicare Part A, B, and D with no HMO coverage for 365 days prior to and including cohort entry date
* 3. Diagnosis code for type 2 diabetes measured 365 days prior to drug initiation

Exclusion Criteria:

* 1. Prior history of dementia measured anytime prior to cohort entry date
* 2. Prior history of nursing home admission in the 365 days prior to the cohort entry date
* 3. Prior use of any GLP receptor agonists (semaglutide, exenatide, liraglutide, albiglutide, dulaglutide, lixisenatide) or DPP4 inhibitors
* 4. Prior use of Semaglutide or DPP4 inhibitors concomitantly on index date
Paxil CR Bioequivalence Study Brazil - Fed Administration

The study is prospective, open, randomized, crossover in steady state and the volunteers received multiple doses of the test drug and the reference drug (two periods of drug administration after standardized meals).

Title: Relative bioavailability study between the formulations: Paroxetine Hydrochloride 25 mg tablet with controlled release (Paxil CR) manufactured by GlaxoSmithKline Inc. - Mississauga - Canada (test formulation) and Paroxetine Hydrochloride 25 mg tablets with controlled release (Paxil CR) manufactured by SmithKline Beecham (Cork) Limited - Cidra - Puerto Rico (reference formulation), fed administration in healthy volunteers of both genders.

The study is prospective, open, randomized, crossover in steady state and the volunteers received multiple doses of the drug test and reference (two periods of drug administration). The population is composed of 60 healthy volunteers, adult of both gender, with age between 18 and 40 years, with a body mass index (BMI) between 18.5 and 27. Volunteers have weight above than 50 kg. 50% of the volunteers recruited are female and 50% male. There are no restrictions regarding the ethnic group.

The relative bioavailability of the formulations after oral administration in steady state will be evaluated based on statistical comparisons of relevant pharmacokinetic parameters obtained from data of drug concentration in blood. The concentration of Paroxetine hydrochloride (controlled release) will be measured by an appropriate analytical method and valid after the drug administration.The Pharmacokinetic samples will be collected at steady state in each period after standardized meals. The safety assessment will include evaluation and clinical monitoring, vital signs monitoring, ECG, and laboratory tests. Adverse events will be monitored throughout the study.

Eligibility Criteria:
EXCLUSION CRITERIA:

* hypersensitivity to the study drug or to compounds chemically related;
* history of serious adverse events;
* concurrent or recent use of other antidepressives, schizophrenia, anticonvulsant;
* History of liver, heart, gastrointestinal or renal illness;
* ECG findings not recommended according to the investigator judgement;
* The volunteer ingests more than 5 cups of coffee or tea a day.

INCLUSION CRITERIA:

* Man and woman (since they are not pregnant or breastfeeding);
* age between 18 and 40 years;
* non-smoker and not addict;
* mass index between 18,5 and 27;
* good health conditions or without significant illness, by judgement of a legally qualified professional;
* sign the informed consent.
Orelabrutinib Combined With Obinutuzumab and Lenalidomide (OGL Regimen) as First-line Treatment for Marginal Zone Lymphoma.

This is a multicenter prospective single arm phase II study, and the purpose of this study is to evaluate the safety and efficacy of orelabrutinib combined with obinutuzumab and lenalidomide in untreated marginal zone lymphoma. The primary objective was the best complete response rate (CRR).

Marginal zone lymphomas (MZL) are a type of lymphoma that originates from the marginal zone tissue of the lymphoid follicles (Mucosa-associated lymphoid tissue, MALT), and include three subtypes: MALT lymphoma, nodal MZL, and splenic MZL. The incidence of MZL is second only to diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma (FL), accounting for approximately 7.8% of all non-Hodgkin lymphomas (NHL). MZL is considered an indolent lymphoma, with patients generally having a better overall survival prognosis. Despite this, some patients still face the challenges of disease relapse or transformation into large cell lymphoma, leading to a poor prognosis.

We conduct this prospective, phase II, single-arm clinical study to initially explore the efficacy and safety of Orelabrutinib combined with obinutuzumab and lenalidomide in patients with previously untreated marginal zone lymphoma. The patients will be treated with 6 cycles of OGL regimen. Patients with CR/PR after 6 cycles of OGL treatment will be treated with 6 cycles of single-agent orelabrutinib regimen.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years, either sex.
* Histopathologically confirmed B-cell non-Hodgkin lymphoma MZL (splenic, nodal, or extra-nodal).
* At least 1 measurable lesion
* Eligible for treatment: meets the GELF criteria, or has clinical symptoms/organ dysfunction related to the disease
* Patients who are not suitable for local radiotherapy or whose condition progresses after local treatment, and those not suitable for local radiotherapy include the following situations:

  * Ann Arbor non-continuous Stage II or Stage III-IV non-gastric MALT and nodal MZL
  * SMZL (Splenic Marginal Zone Lymphoma)
  * Gastric MALT with Lugano Stage II2/IIE/IV
* ECOG performance status (PS) score of 0-2.
* Expected survival time is ≥3 months
* Sign the Informed consent

Exclusion Criteria:

* Currently has other malignant tumors;
* Lymphoma involving the central nervous system
* Allergic to any of the study drugs;
* Active infection or uncontrolled HBV infection (DNA\&gt;105/ml), HIV/AIDS, or other severe infectious diseases;
* Pregnant or lactating women and women of childbearing age who are unwilling to use contraception;
* Any other conditions deemed unsuitable for participation in this trial by the investigator.
Internet-based Universal Parent Training as a Booster to PATHS®: Parent Web

To test an online parent training program. Relative to a matched comparison, those in the Parent Web (PW) will show benefits on well-being, parenting, stress, youth mental health. Parents of PATHS children are the immediate intervention group.

Parent-Web (PW) is internet delivered and rooted in social learning and coercion theory, PW supports parenting practices and parent-child interactions encouraging prosocial behavior and emotion regulation, reduce coercive parenting, improve communication, problem solving, and warmth. PW has a universal and selective edition. Universal PW has 5 basic modules (1 module per week, 6-8 weeks) and bonus modules. Basic modules contain information, exercises, and videos of actors showing parenting practices. A family guide supports PW participants through PW modules. No published outcome evaluations of universal PW currently exist. However, benefits were found for selective PW. This study will test the effects of universal PW as a booster to PATHS (Promoting Alternative Thinking Strategies) a universal school-based intervention designed to enhance child social emotional competence. All PW trial participants are parents to at least one adolescent child (aged 11-13). Immediate PW participants are parents who have a child that participated in PATHS at age 4-5 years old.

Eligibility Criteria:
Inclusion Criteria:

Immediate intervention group are parents of children aged 11-13 who participated in PATHS at age 4-5 years old.

Parents in the wait list comparison group have children who are matched to the children of parents in the immediate intervention group.

Matching criteria are:

Wait-list group parents' child's present-day gender (matching criteria 1) is the same as the matched child who's parents are in the immediate intervention group, wait-list group parents' child's present-day age is similar to the matched child who's parents are in the immediate intervention group, namely child birthdays within 6 months of each other (matching criteria 2), and wait-list group parents' children live in the same postal code as the matched immediate intervention group child (matching criteria 3), and matched children have all lived in Sweden since 2014 (matching criteria 4). If these 4-matching criteria are too restrictive and do not provide enough matches to recruit from, then the matching criteria will be reduced to points 1, 2, and point 3. Children do not participate in the Parent Web intervention trial, but parents of children do participate.

Exclusion Criteria: See inclusion criteria
Improving Healthy Living Opportunities: Laurel HARVEST

The goal of this pre-post intervention study is to understand how community-engaged approaches to policy, systems, and environmental approaches can work to improve fruit and vegetable consumption and food security status among an Appalachian Kentucky community. The main approaches taken will be to employ a Community Advisory Board to define our target population of need, and appropriate intervention strategies. The investigators aim to understand if nutrition-based programming and food system approaches for lower-income, single-parent households, and multi-generational households can improve health. Participants will engage in annual data collection to assess dietary quality and food security status.


Eligibility Criteria:
Inclusion Criteria:

* Resident of Laurel of Pike County
* Over 18 years of age

Exclusion Criteria:

* Pregnancy
* Non-English speaking
* Plans to move out of the counties within the next three years
Health-related Quality of Life of Patients With Neurogenic Bladder

Bladder management has a major impact on the quality of life in patients with neurogenic bladder dysfunction. This a prospective investigation of the effects of the method for bladder evacuation on the health-related quality of life in patients with neurogenic bladder dysfunction. The changes in health-related quality of life over time (longitudinal investigation) and the differences between the different methods for bladder evacuation will be investigated. Patients will be given a standardized and validated questionnaire annually for 10 years.


Eligibility Criteria:
Inclusion Criteria:

* Individuals with neurogenic bladder dysfunction

Exclusion Criteria:

* Insufficient dexterity to fill in the questionnaire
* Insufficient proficiency in the German or French language
Randomized Clinical Trial on Preoperative Radiotherapy 25 Gy in Rectal Cancer

The purpose of this study is to establish the influence of time-interval between preoperative hyperfractionated radiotherapy (5x5 Gy) and surgery on long term overall survival (5 years), local and distant recurrence rate, downstaging rate, sphincter saving procedures, radical resection rate (R0) in patients with locally advanced rectal cancer operated on according to TME technique. In particular 3D endosonography and 3rd generation ultrasonic contrast agents are evaluated to assess response to radiotherapy.

The treatment group comprises patients with locally advanced rectal cancer who were operated on in the 1st Department of General Surgery, Jagiellonian University, Cracow. The data on survival has been systematically collected using national census registry. Patients are qualified to preoperative radiotherapy 5x5 Gy and then randomly assigned to subgroups with different time interval between radiotherapy and surgery: one subgroup consists of patients operated on 7-10 days after the end of irradiation, the second subgroup consists of patients operated on after 4-5 weeks. Both should be homogenous in sex, age, cancer stage and localization, distal and circumferential resection margins, number of resected lymph nodes. 3D endorectal ultrasound and endorectal ultrasound with SonoVue are performed to assess the tumor before and after preoperative radiotherapy.

Eligibility Criteria:
Inclusion Criteria:

* histologically confirmed rectal cancer
* tumor localised in middle or lower rectum
* age \> 18 years
* locally advanced cancer

Exclusion Criteria:

* previous pelvis radiotherapy
* lack of patient's consent
* lack of possibility to begin radiotherapy during 14 days after inclusion to the study
Perinatal Arterial Stroke Treated With Stromal Cells Intranasally

This study will assess safety and feasibility of bone marrow-derived allogeneic MSCs, administered by the nasal route, in neonates who suffered from PAIS.

Perinatal arterial ischemic stroke (PAIS) is an important perinatal cause of long-lasting neurodevelopmental problems. Recent studies report an incidence of PAIS of 1 per 2300 full-term infants born alive. Adverse consequences of PAIS include hemiplegia, cognitive dysfunction, epilepsy and speech problems. In 50-75% of infants, neonatal stroke leads to abnormal neuromotor and -developmental outcome or epilepsy. The estimated annual mortality rate of neonatal stroke is 3.49/100,000 annually. Current treatment options for PAIS mainly focus on controlling convulsions and associated infections. There is no treatment available that leads to reduction of neonatal brain damage in this severely affected group of infants. This leads to life-long consequences of PAIS and forms a large burden for patients and society. The overall aim of this project is to meet this need by developing a cell based treatment strategy. Animal models of neonatal brain injury provide evidence for the feasibility and efficacy of intranasal mesenchymal stromal cell (MSC) application in the treatment of PAIS. Additionally, results from human trials with MSCs in the treatment of adult stroke or other pathologic conditions provide evidence that MSC treatment is safe. This project aims at making the first step towards clinical application of MSCs to treat PAIS. Successful completion of this project will provide the first evidence of the safety and feasibility of MSCs to treat brain damage in newborn infants. This study will assess safety and feasibility of bone marrow-derived allogeneic MSCs, administered by the nasal route, in neonates who suffered from PAIS.

Eligibility Criteria:
Inclusion Criteria:

* (Near-)Term infants, ≥36+0 weeks of gestation, admitted to one of the Dutch Neonatal Intensive Care Units, diagnosed with PAIS, confirmed by MRI within 3 days after presentation with clinical symptoms.
* PAIS as characterized by a predominantly unilateral ischemic lesion within the territory of the middle cerebral artery, with involvement of the corticospinal tracts, cortex, white matter and basal ganglia.
* Written informed consent from custodial parent(s).

Exclusion Criteria:

* Any proven or suspected congenital anomaly, chromosomal disorder, metabolic disorder.
* Presence of an infection of the central nervous system.
* No realistic prospect of survival, (e.g. severe brain injury), at the discretion of the attending physician.