cyrilzakka/clinical-trials huggingface dataset:
REBECCA-3 Study, Research on Breast Cancer Induced Chronic Conditions Supported by Causal Analysis of Multi-source Data

The overall aim of the REBECCA project is to exploit the potential of "real-world data" to support clinical research and improve existing clinical workflow. The primary aim of the REBECCA-3 study is to use multi-source "real-world data" to monitor the quality of life (QoL) of prostate cancer patients who are affected by cancer-related fatigue during and after treatment. This is to investigate whether the REBECCA monitoring is accepted by male patients and can be used within various forms of cancer.

Study design: 40 prostate cancer patients that undergo radiology and/or chemotherapy treatment will be included at the time of diagnosis. After end of primary treatment, the patients will receive a smartwatch, and have to download a REBECCA patient app on their mobile and a PC plug-in on their PC so that we can monitor their QoL for 4 months. In addition to collecting digital QoL parameters through the REBECCA-system, patient-reported QoL measures will also be collected through standardized PROMs and self-evaluation forms. Further, biological samples (blood, urine, and faeces) are collected at three time points of the study (i.e., at the time of: diagnosis, completed treatment, and 4 months post treatment), to investigate immunologic biomarkers, DNA methylation patterns and microbiota for assessment of new biological and prognostic information related to the development of cancer-related fatigue in prostate cancer patients.


Eligibility Criteria:
Inclusion Criteria:

* Prostate cancer patients with histologically detectable M0 prostate cancer requiring primary surgery or primary radiation therapy followed by hormone therapy at least and no more than 3 months of initiation prior to study start
* Male prostate cancer patients under 80 years of age.
* Patients who have an increased life expectancy beyond the first 3 months after starting treatment.
* Patients who have the ability to understand the protocol and can participate in the follow-up plan.
* Patients who have the absence of psychological, familial, sociological, or geographic condition potentially hindering compliance with the study protocol and follow-up schedule.
* Patients who have a smart phone.

Exclusion Criteria:

* Patients who do not consent to the study protocol.
* Patients with a previous cancer diagnosis (except skin cancer treated only by surgery).
* Patients who have previously been treated with any form of chemotherapy/radiotherapy.
* Foreign-language patients without sufficient Norwegian understanding
* Patients who do not have a smartphone
Validation of the New HAG-B19 Scale for Measuring Lean and Fat Body Masse

Body composition measurement is an important tool for assessing the physical condition of sick or healthy people, as well as for monitoring changes in body composition and physical performance during diet and/or training. Many people self-monitor their body composition using portable and inexpensive assessment tools, but most of them have not been tested for accuracy and precision.

This study aims to assess the accuracy and precision of a new portable impedancemeter scale to measure body composition in comparison with proven techniques, such as 4-electrode electrical bioimpedance analysis and dual X-ray absorptiometry.

This is an observational, prospective, cross-sectional study to evaluate the accuracy and precision of the new HAG-B19 in healthy Western adults. A stratified sampling method is used to recruit a heterogeneous sample of 160 subjects, covering a wide range of ages and body compositions according to gender specific BMI distributions in the population. Volunteers who signed the informed consent form are included in the study. A financial compensation of 50.- CHF is given to each participant (100.- to the 16 participants subjected to the DEXA measurements).

The body composition of each subject (FM, LBM and FM%) is assessed with sequential measurements using 3 HAG-B19 and 3 Nutriguard-M® devices (Data Input, Germany). FM% values measured by HAG-B19 are compared to values by Nutriguard-M® to assess the accuracy and precision of HAG-B19 (main objective). Intra- and inter-device variability are obtained by comparing the 3 repeated measurements and the 3 HAG-B19 devices (secondary objective). In a subgroup of 16 individuals, the FM% values measured by HAG-B19 are compared to DEXA measurements (secondary objective). Pearson correlations and Bland-Altman graphs are performed to assess the agreement of the measurements between the devices and paired t-tests are used to determine if there is a bias between the devices. The significance of the statistical analysis is fixed at p \<0.05.

Eligibility Criteria:
Inclusion Criteria:

Healthy Caucasians/Hispanics adults who signed the informed consent form (healthy defined as no chronic disease, no hospitalisation for the last 6 months, no physical disability)

Exclusion Criteria:

* BMI \<18.5 or ≥ 30 kg/m2
* No informed consent form signed
* Inability to understand the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant.
* Medication impacting fluid and electrolyte balance (diuretics or calcium channel blocker)
* Moderate to intense level physical activity 2-3 h before measurement
* Pregnancy
Effectiveness and Tolerability of Lidocaine 5% Spray in Treatment of Lifelong Premature Ejaculation Patients.

This study aimed to appraise effectiveness and tolerability of lidocaine 5% spray in treatment of patients with premature ejaculation (PE). The current study has been designed as a randomized single-blind placebo-controlled clinical trial. It was done on 150 lifelong PE patients with normal erection. They were randomized evenly categorized into two treatment groups. Group 1 (n₌75); was given on demand lidocaine 5% spray for 8 weeks. Group 2 (n₌75); was given placebo in form on demand alcohol spray for 8 weeks.

This study aimed to appraise effectiveness and tolerability of lidocaine 5% spray in treatment of patients with premature ejaculation (PE). The current study has been designed as a randomized single-blind placebo-controlled clinical trial. It was done on 150 lifelong PE patients with normal erection. They were randomized evenly categorized into two treatment groups. Group 1 (n₌75); was given on demand lidocaine 5% spray for 8 weeks. Group 2 (n₌75); was given placebo in form on demand alcohol spray for 8 weeks. All medications were applied on the glans penis for 10-20 minutes and then cleaned before planed sexual intercourse. Patients were evaluated with Arabic Index of Premature Ejaculation (AIPE) scores, intravaginal ejaculatory latency times (IELTs), and frequency of sexual intercourse before and after treatments.

Eligibility Criteria:
Inclusion Criteria:

Clinical diagnosis of lifelong premature ejaculation

Exclusion Criteria:

1. renal or liver diseases,
2. diabetes mellitus,
3. thyroid diseases,
4. chronic prostatitis,
5. neurological diseases
6. allergic reactions to local anesthetics or alcohols.
7. erectil dysfunction
Protein Kinase A in Prostate Cancer Tissue.

Prostate cancer is the most common malignancy in men. documented risk factors of prostate cancer are age, ethnicity, various genomic mutations and family history of prostate cancer. The cellular mechanisms of malignant transformation are numerous and not completely understood. A possible mechanism is induction of an inflammation resulting in cellular atypia and pre-malignant changes in the affected tissue by inducing a pro-inflammatory response or changes in extra cellular matrix. Protein Kinase A (PKA) is a key stone enzyme in various intra-cellular processes. Various infections' inflammations and malignancies were proved to impact PKA activity. The research hypothesis is that prostate cancer tissue will show a unique profile of PKA activity, regulation and intracellular distribution.

The study will be conducted among men referred to prostate biopsy due to clinical suspicion of malignancy. 100 consecutive patients will undergo prostate biopsies. Biopsies will be taken from both lobes of the prostate (standard protocol) and additional biopsies will be taken according to MRI findings (Fusion biopsies) if relevant. One additional biopsy will be taken from each lobe of the prostate and immediately freezed in -80 Celsius degrees. Routine biopsies will be fixed in formaldehyde and embedded in paraffin and will undergo routine pathological analysis and staining.

Following pathological analysis, paraffin slides will be undergo immunohistochemically staining for PKA, comparing cancerous tissue to normal surrounding tissue. the fresh frozen tissue will undergo western blot analysis for quantitative expression of PKA and its sub units.

Eligibility Criteria:
Inclusion Criteria:

* Men
* Clinical suspicion of prostate cancer
* Referred for biopsy
* Able to sign informed consent.

Exclusion Criteria:

* Previous prostate irradiation
* Chronic prostatitis
* Previous prostate surgery
* Recent urinary tract infection (3 months prior to biopsy).
* Indwelling urinary catheter
Study on Effects of a Dairy Product Based on Polyphenols and Enriched With Vitamins B6, B9 and B12 on Some Cardiovascular Factor of Risk

We put forward that polyphenols and vitamins have a cardiovascular prevention effect for subject with cardiovascular risk.


Eligibility Criteria:
Inclusion Criteria:

* BMI less than 33 kg/m²
* Waist measurement higher than 90 cm for woman and 100 cm for man
* Normal or controled blood pressure (less than 16/9)
* non-smoker
* Female with contraception

Exclusion Criteria:

* Food allergy
* Cardiovascular pathology
* Medical treatment for cholesterol
* Higher consumption for dairy product and red fruit
Prevention of Clostridium Difficile Infections Using Lactobacillus Plantarum 299v Strain

The aim of this study was to analyze whether the use of the LP299v strain reduces the risk of Clostridium difficile infection (CDI) among patients receiving antibiotics and hospitalized in the nephrology and transplantation ward.

Patients from risk group (receiving immunosuppressive drugs and treated with antibiotics) were enrolled into study.

Participants will be divided into two groups. First group will receive one capsule of Lactobacillus plantarum 299v (LP299v) orally per a day. Second group will receive placebo.

Clostridium difficile is currently the most frequently identified pathogen causing antibiotic-associated diarrhoea and the main cause of nosocomial diarrhoea. In regard to observed worldwide increase rate of infection and mortality from CDI the prevention of Clostridium difficile infections seems to be crucial, especially in patients at CDI high risk. So far, it has not been unambiguously proven that probiotics are effective in the prevention of Clostridium difficile infection among patients undergoing antibiotic therapy.

The Lactobacillus plantarum 299v (LP299v) is a Gram-positive lactic acid bacteria that naturally occurs on the surface of human intestinal mucosa. Specific properties to the gut mucosa colonization are due to mannose-dependent adhesion of LP299v to the epithelium of human intestines.This ability of LP299v leads to reduction of bacterial translocation from the intestinal lumen into the blood vessels, can prevent adhesion of many pathogens to intestinal epithelium and modulate the inflammatory response of the epithelium. The strain 299v of Lactobacillus plantarum has been found to decrease the severity of gastrointestinal adverse effects during antibiotic therapy. Limited data are available regarding the efficacy of LP299v for preventing Clostridium difficile infections.

Eligibility Criteria:
Inclusion Criteria:

* over 18 years old
* organ transplantation or receiving immunosuppressive drugs for any other reasons
* antibiotics therapy

Exclusion Criteria:

* no consent to participate in the study
Correlation Between External Jugular Venous and Superior Vena Cava Central Venous Blood Oxygen Saturation in Patient Under General Anesthesia

After installation of central venous catheter in patients under general anesthesia, paired sample of superior vena cava central venous blood and right external jugular venous blood will be collected and send to central laboratory for venous blood gas analysis. Correlation between superior vena cava central venous blood and right external jugular venous blood oxygen saturation will be determined as primary outcome.

All patients age between 18-65 year old who undergoing surgery under general anesthesia and superior vena cava central venous catheter installation anticipated are eligible. The tips of superior vena cava central venous catheter was confirmed by Chest x-ray. Next 1 hour after skin incision, 1 ml of venous blood sample is taken from superior vena cava central venous catheter of right external jugular vein then send to central laboratory for venous blood gas analysis. The demographic data will be recorded. Correlation between superior vena cava central venous blood and right external jugular venous blood oxygen saturation will be determined the primary outcome and partial pressure of carbon dioxide will be determined as a secondary outcome.

Eligibility Criteria:
Inclusion Criteria:

* Written consent obtained from patient or next of kin a day before operation date
* Patient age between 18-65 years old undergoing syrgery under general anesthesia
* Superior vena cava central venous catheter anticipated for CVP mesurement, innotropic or vasopressor administration,pulmonary artery catheter insertion route
* Anticipated right external jugular venous sampling time less than 5 minutes
* The site of blood sample collection easily access during operation

Exclusion Criteria:

* No jugular central venous catheter installation or other route selected
* Duration of paired sample collection more than 10 minutes
* Can not collected blood sample from right external jugular vein within 3 attemps
* The site of blood sample collection difficulty access during operation
* Pateint or next of kin refuse to participate
Effectiveness of the Croq'Santé Nutrition Education Program in Improving Food Literacy in Schoolchildren

Background: Nutritional factors including diet, physical activity, weight status and alcohol consumption are among the most important preventable risk factors for cancer. Interventions are needed to help children make the right choices in a complex food environment. The JDB Foundation designs primary cancer prevention projects through health education targeted at young people. It has designed the "Croq'Santé" project, which aimed to reduce the risks associated with overweight and obesity by improving food literacy of children aged 8 to 11, corresponding to the 4th and 5th grades. Briefly, food literacy refers to having the knowledge, skills and attitudes to choose, prepare and enjoy healthy foods. Accompanied by their teacher, a class will create a balanced recipe (or re-adapt an existing one) through a series of stages (10 sessions in total), allowing children to explore the foods and stakeholders in the food chain, understand nutrition, cook and taste new flavors. Objectives: The primary objective of this study is to evaluate whether the intervention successfuly improves the food literacy of 8- to 11-year-olds. Secondary objectives include examining the influence of socioeconomic factors on the program's effectiveness and process evaluation. Methods: We intent to conduct a quasi-experimental before-and-after study including 60 classes (approximately 1500 children). The classes in the intervention group will receive the Croq'Santé program, while the classes in the control group will receive usual school nutrition education. The schools participating in the control group will have the possibility to receive the Croq'Santé program the following year if they wish. The primary outcome will focus on changes in food literacy, measured using a child-friendly questionnaire administered before and after the intervention. Other information will be collected at child level (e.g. gender, age, family composition) and school level (e.g. socioeconomic indicators). Expected results: Cancer remains the leading cause of death in France and the production of knowledge on the effectiveness of public health interventions is essential to guide prevention strategies. If the Croq'Santé programme actually shows its effectiveness, it could be scaled up and adapted to different contexts.


Eligibility Criteria:
Inclusion Criteria:

* children in 4th and 5th grades
* attending a school participating in the study
* child and parental consent

Exclusion Criteria:

- classes that took part in the questionnaire pre-test
Comparison of Neuromodulatory Treatment of Migraine Headache with Acupuncture and Transcranial Direct Current Stimulation

The goal of this clinical trial is to compare effects of the treatment with acupuncture and transcranial direct current stimulation (tDCS) in patients with migraine headache. The main questions it aims to answer are:

* is tDCS more effective than acupuncture/placebo?
* is there any difference in venous blood inflammatory parameters (CGRP (calcitonin gene related peptide), IL (interleukine) -6, IL-8. IL-10, SAA (serum amyloid A) and ESR (erythrocyte sedimentation rate) before/after treatment?
* could these inflammatory parameters function as biomarkers of disease and/or indicators of treatment's efficacy?

Participants will regularly fill out questionnaires (migraine diary) and their venous blood before/after treatment will be taken for analysis.

Researchers will compare the effects of sham and verus treatment of both methods before and after treatment.


Eligibility Criteria:
Inclusion Criteria:

* 4 migraine days per month
* no acupuncture in the past
* understanding of study design and ability to give informed consent

Exclusion Criteria:

* severe psychiatric disorders
* pacemaker
* status post brain surgery with open skull
* brain stimulators
* metal implants
* biologic drugs
* pregnancy
DWIBS-MRI: An Adjunct to the Traditional Diagnostic Breast Imaging Evaluation

1.1. Primary Objectives

* To determine if MRI DWIBS can accurately identify suspicious lesions previously categorized on mammography and sonography as potentially malignant.
* We will also validate whether DWIBS-MRI ADC values can be used to accurately differentiate benign from malignant lesions. Additionally, because it is not known whether tumor type or growth rate (Ki67 values) will affect our results, we will include these parameters in our analysis.
* Once we validate the use of DWIBS-MRI ADC values to determine malignancy, can we establish an ADC threshold value to decrease the number of false positive biopsies that are performed while still maintaining a zero false negative rate?
* This study will also assess the correlation between ADC values and the Ki-67 proliferative index of malignant lesions.


Eligibility Criteria:
Inclusion Criteria:

* A patient will be eligible for inclusion in this study if she meets all of the following criteria:

  1. \>30 years of age
  2. Genetic Female
  3. Suspected diagnosis of BIRADS 4 or BIRADS 5 masses and/or asymmetries greater than 1 centimeter based on standard 2D/3D mammogram and ultrasound imaging.

Exclusion Criteria:

* A patient is ineligible for inclusion in this study if she meets any of the following criteria:

  1. Prior biopsy of suspicious lesion
  2. Breast implants
  3. Prior history of breast cancer
  4. Patient has a pacemaker
  5. Contraindications to use of MRI imaging (metal implants, etc.)
  6. Woman pregnant or lactating
  7. Calcifications as only findings present for a suspicious lesion
Use of GeriKit to Better Phenotype Older Adults With Ischemic Heart Disease

This study seeks to expand the use of the NYU GeriKit mobile application ("app") in a diverse range of settings to better phenotype older patients, which will enhance both research and patient care.

This is a single-center proof of concept study of geriatric impairments and feasibility metrics through the use of the GeriKit software application in older adults with ischemic heart disease at the NYU Langone Medical Center. The GeriKit mobile application was developed to make geriatric assessment instruments easily accessible to clinicians who do not have subspecialty training in geriatrics. The GeriKit app has been used clinically but is untested in research settings.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 75
2. Currently hospitalized for acute mycardial infarction (AMI), percutaneous coronary intervention (PCI), or coronary artery bypass grafting (CABG); or hospitalized for AMI, PCI, or CABG within the prior 4 weeks
3. Capable of self-consent
4. Understand and are able to perform study procedures in English

Exclusion Criteria:

1. Non-ambulatory
2. Moderate or severe cognitive impairment (operationalized as known diagnosis of dementia)
3. Unable or unwilling to consent
4. Incarcerated
5. Unable to use complete assessments in English
6. Unable to complete geriatric assessment for other reasons
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AJ302-IM in Healthy Volunteers

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of AJ302-IM following intramuscular administration of single ascending doses in healthy volunteers.


Eligibility Criteria:
Key Inclusion Criteria:

* Male or female, non-smokers (no use of tobacco or nicotine products within 3 months prior to screening), ≥ 18 and ≤ 55years of age, with body mass index (BMI) ≥ 18.5 and ≤ 30.0 kg/m2 and body weight ≥ 50.0 kg for males and ≥ 45.0 kg for females.
* Normal renal function at screening.
* Healthy as defined by:

  * The absence of clinically significant illness and surgery within 4 weeks prior to study drug administration.
  * The absence of clinically significant history of neurological, endocrine, cardiovascular, respiratory, hematological, immunological, psychiatric, depression, attempted suicide, gastrointestinal, renal, hepatic, and metabolic disease.
* Able to understand the study procedures and provide signed informed consent to participate in the study

Key Exclusion Criteria:

* Any clinically significant abnormal finding at physical examination
* Any lifetime suicidal behavior or suicidal ideation of type 4 (active suicidal ideation with some intent to act, without specific plan) or type 5 (active suicidal ideation with specific plan and intent) in the 2 years before screening based on the C-SSRS
* Clinically significant abnormal laboratory test results or positive serology test results for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, or human immunodeficiency virus (HIV) antigen and antibody, at screening
* Positive pregnancy test or lactating female volunteers
* Positive urine drug screen, urine cotinine test, or alcohol breath test at screening and on Day -1
* History of significant allergic reactions to any drug
* Known allergy or hypersensitivity to histone deacetylase 6 (HDAC6) inhibitors or its derivatives and/or any study product excipients
* Clinically significant ECG abnormalities or vital signs abnormalities at screening
* History of drug abuse or recreational use of soft drugs or hard drugs
* History of alcohol abuse
* History of smoking or uses other nicotine-containing products
* Undergone major surgery ≤ 2 months before study drug administration
* History of clinically significant opportunistic infection or serious local infection or significant medical/surgical procedure or trauma, or any current infection.
* Use of medications for the timeframes specified in the protocol
* Received any investigational drug or any investigational device or any biological product within the timeframes specified in the protocol
* Tattoos, sunburn, scarring or anything that may interfere with evaluation of the injection site