cyrilzakka/clinical-trials huggingface dataset:
Study Accelerometer Signals to Measure Daily Activities (SASMDA)

The purpose of this study is to determine if it is possible to identify activities in the daily accelerometer measures of a person with urinary disorders.


Eligibility Criteria:
Inclusion Criteria:

* man
* patients fitted with artificial urinary sphincter
* patients affiliated to social security or similar regime

Exclusion Criteria:

* patient do not speak french
* patient unable to express his consent
* patient hospitalize without consent
* patient under legal protection
* patient deprived of liberty
CALERIE (Tufts) - Comprehensive Assessment of Long-term Effects of Reducing Intake of Energy

This study is one of three CALERIE trials that test the hypothesis that a reduced calorie, nutritionally sound diet increases the length of life and prevents some age-related chronic diseases such as cancer, diabetes, and cardiovascular disease. The three sites that are participating in the CALERIE trial represent a diversity of subject populations and interventional strategies.

Researchers at the Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University are enrolling overweight men and women aged 20-42 in a 1-year study to develop an effective calorie restricted regimen that minimizes hunger and prevents weight regain. The study also examines the effects of weight loss on body composition, metabolism and aging. Two different diets containing usual foods and a healthy balance of nutrients will be tested at 2 levels of caloric restriction, 10% and 30% (in other words, 90% or 70% of what one would normally eat). Weight loss is expected for most volunteers participating in this study, but cannot be guaranteed.

Eligibility Criteria:
Inclusion Criteria

* Healthy men and women
* Body mass index (BMI) = 25-30
* Slightly overweight, \< 275 lbs
* Women 25-45, pre-menopause
* Men 25-50
* Not traveling often or planning to move

Exclusions:

* Cardiovascular disease or blood pressure greater than 160/90
* Diabetes
* Major psychiatric disorders
* Eating disorders
* Post obese; previous BMI \> 32
* Weight change of more than ten pounds in the past 90 days
* Over 275 pounds
* Smoking
* Regular exercise, more than twice per week
* Current prescription drug use, except oral contraceptives
* Alcoholism or substance abuse
* Pregnant or lactating (breast feeding), planning to become pregnant, or not regularly using contraception
* Abnormal electrocardiogram (EKG)
* Local resident for less than one year
* Occupations requiring full alertness and motor skills, with no allowance for a chance of postural dizziness (airline pilots, etc.)
* Injuries by any metallic object that is still present in the body
* Braces, non-removable dentures, or non-removable bridgework
Abbreviated Breast MRI for Second Breast Cancer Detection in Women With BRCA Mutation Testing

Study Purpose:

A multicenter prospective study to evaluate the outcome of second breast cancer surveillance with abbreviated breast MR (AB-MR) or ultrasound (US) in addition to annual mammography in women with BRCA1/2 mutation testing

Study Scheme:

* AB-MR, US, and digital mammography will be performed on the same day and interpreted independently at baseline and then after 1 year.
* After completion of study, patients are followed-up for at least 1 year.

For women with a BRCA1/2 mutation who are treated for breast cancer, screening of remaining breast tissue with annual mammography and breast MRI is recommended. For women who met BRCA testing criteria but show an uninformative negative result or a variant of unknown significance (VUS) result, there is no established recommendation for second breast cancer surveillance.

Abbreviated breast MRI (AB-MR) is a fast and low-cost examination that show equivalent diagnostic accuracy to that of the standardized dynamic protocol breast MRI. Breast ultrasound (US) can detect additional cancers that are occult on mammography and is indicated in high-risk patients who cannot tolerate MRI.

The purpose of this multicenter prospective study is to evaluate the outcome of second breast cancer surveillance with AB-MR or US in addition to annual mammography in women with BRCA1/2 mutation testing.

AB-MR, US, and digital mammography will be performed on the same day at baseline and then after 1 year and images will be interpreted independently according to the Breast Imaging Reporting and Data System (BI-RADS) by experienced radiologists. The BI-RADS category 3 or higher is defined as test-positive. The reference standard will be a biopsy or at least 1 year of follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Women aged between 25 years and 75 years with a personal history of breast cancer
* BRCA mutation test done (meeting any of the following criteria): 1) early-age-onset breast cancer (40 years or younger), 2) bilateral breast cancers (synchronous) 3) personal history of ovarian cancer and/or other multiple primary cancers 4) family history of breast and/or ovarian cancer in first- or second-degree relatives
* No symptom or sign of secondary breast cancer (no palpable mass, bloody nipple discharge, abnormal skin change, nipple retraction)
* Written informed consent is given

Exclusion criteria:

* Initial breast cancer stage IV
* Bilateral mastectomy done
* Diagnosis of second breast cancer or regional/distant metastasis
* Systemic chemotherapy for any cancer
* Pregnant or lactating
* Contraindication to breast MRI with contrast enhancement
Identification and Standardization of a Method That Would Allow the Study of the Metabolic Profile of Blastocoele Lays the Foundation to Assess Blastocyst Metabolomic Profile and Its Relation With Embryo Morphology and Embryo Implantation

While the number of assisted reproduction cycles increases worldwide, the introduction of actual technological improvements in the ability to quickly and non-invasively identify the best embryos for transfer still represents a critical goal for reproductive medicine. Indeed, embryo assessment is currently performed through the analysis of morphology and cleavage rate. Recent studies have sought to identify a correlation between qualitative-quantitative profiles of small molecules of metabolic interest and the outcome of embryo transfer. Some of these molecules seem to be best suited for this purpose, including glucose, lactate, pyruvate or amino acid levels. Approaches relying on both optical and non-optical spectroscopy have been proposed to non-invasively monitor the embryo culture media. However, the non-invasive approach only offers an indirect strategy to monitor embryos and a turn-around solution to bypass the limits of detection of these analytical techniques. In this paper the investigators pave the way for direct assessment of embryos through the mass spectrometry-based analysis of blastocoele fluid, which is withdrawn from the blastocoele cavity prior to cryostorage of blastocysts. The investigators show how it is possible to detect most of the already documented metabolites of interest right at the very heart of the blastocyst, without disrupting the workflow of a classic laboratory pipeline.


Eligibility Criteria:
Inclusion Criteria:

* Ovarian hyperstimulation disease
* Blastocyst formation
Modulating Stress-Reactivity by Real-Time Multimodal Functional Neuroimaging Based Neurofeedback

The overall goal of the outlined study is to establish a Real-Time (RT) functional Magnetic Resonance Imaging (fMRI) Neurofeedback (NF) (RT-fMRI-NF) protocol aiming at modulating neural, endocrine, and subjective reactivity to psychosocial stress.

The overall goal of the outlined study is to establish an RT-fMRI-NF protocol aiming at modulating neural, endocrine, and subjective reactivity to psychosocial stress. More specifically, the investigators pursue the following goals: a) to evaluate whether neural and subjective stress-reactivity can be modified by training volitional control over targeted brain activity by means of RT-fMRI-NF; b) to evaluate whether neuromodulation by means of RT-fMRI-NF can be used as a new way to modulate hormone-release into the periphery; and c) to evaluate whether the efficacy of neuromodulation by RT-fMRI-NF can also be reflected on EEG data as well as the autonomic nervous system (ANS) measured by heart rate variability (HRV).

Eligibility Criteria:
Inclusion Criteria:

* Sufficient spoken and written knowledge of English
* Right-handedness
* Ability to participate in study procedures

Exclusion Criteria:

* Present or past psychological or psychiatric therapy
* Major or unstable general medical conditions
* Presence of cardiovascular disease
* Current intake of any medication interfering hormonal assessments
* History of major cerebral injury
* Medical MRI contraindication
Virtual Physical Rehabilitation for Patients Living with Long COVID

The purpose of this study is to investigate whether a timely, virtual home-based physical rehabilitation program for patients living with long COVID can improve functional mobility compared to usual care.


Eligibility Criteria:
Inclusion Criteria:

(i) adult patients (18+ years old) who have had a confirmed or probable COVID-19 infection and who have self-reported persisting symptoms of either reduced mobility, muscle weakness, dyspnea, or fatigue;

(ii) participants must be technologically capable of connecting (either independently or through household members) with an online videoconferencing platform through an e-mail invitation; and

(iii) be able to collaborate with the research assistant to complete the virtual assessment sessions or have a family member available to help.

Exclusion Criteria:

(i) pre-existing or newly identified severe cognitive impairment;

(ii) inability to speak or comprehend English or French;

(iii) known or self-reported acute and/or uncontrolled cardiac, musculoskeletal, or neurological condition that might render rehabilitation participation unsafe.
Isotretinoin Versus Excimer Light an Adjuvant in Treating Onychomycosis

3 groups of patients with onychomycosis will be recruited. Group A will receive itraconazole alone. Group B will receive itraconazole + low dose isotretinoin and group C will be treated with itraconazole + excimer light sessions.

The sample size will be calculated by a statistician based upon the rate of onychomycosis cases attending at the outpatient clinical. 3 equal groups of patients will be included. inclusion criteria include: -definite diagnosis of dermatophyte onychomycosis using KOH examination and a fungal culture - a washout period of at least 1 month of any previous therapy -age\> 16 years Exclusion criteria include: -pregnancy and lactation -Any active infection or inflammation in or around the nails other than onychomycosis -patients with liver diseases, heart disease and diabetes

Steps of performance and techniques used:

1. Complete history taking.
2. Detailed local examination:

Local examination will be done for the nail to detect swelling, induration, erythema around the nail, local pain and presence of pus during the sessions.

Patients with proven onychomycosis clinically, dermoscopically and through culture will be included in the study.

The included patients will sign an informed written consent before the beginning of the study, and the study will be done under the approval of the ethical committee for postgraduate studies and research of faculty of Medicine, Zagazig University.

Onychomycosis severity index (OSI) will be used for grading of onychomycosis severity where 0=no onychomycosis,1-5= mild onychomycosis,6- 15=moderate onychomycosis, and 16-35=severe onychomycosis.

The patients will be divided into 3 equal groups:

GROUP 1: (itraconazole group); all patients will be prescribed Itraconazole in the dose of 200mg twice daily for 1 week per month, for 3 consecutive months after screening of complete blood count, liver, and renal function tests. patients were advised to record any side effects.

GROUP 2 : will be given low dose of isotretinoin as an adjuvant to itraconazole in the same previously mentioned protocol.

Treatment protocol consists of low dose isotretinoin 20mg, every other day for a 3- month course. After completion of the course, treating dose of isotretinoin will be maintained for 4-6 weeks to prevent recurrence, and to improve healing. During treatment, an infrequent application of the previous therapies will be permitted.

GROUP 3: will be treated with excimer light as an adjuvant to itraconazole in the same previously mentioned protocol. Nails will be treated with XeCl2 excimer light (Eximal Elite Device).

Eligibility Criteria:
Inclusion Criteria:

* patients with onychomycosis

Exclusion Criteria:

* pregnant and lactating females patients on statin therapy or photosensitizing drugs patients with liver disease, heart disease and diabetes milletus.
Volumetric Analysis of Hepatocellular Carcinoma After Transarterial Chemoembolization

The application of transarterial chemoembolisation (TACE) with drug-eluting beads in patients with hepatocellular carcinoma and its response to the treatment will be observed. The registry has the following objectives:

To assess the response to the treatment by standard methods and volumetric analysis as well as trying to determine any predictive response factors To determinate interobserver variability of the methods.

The patients with hepatocellular carcinoma in stage suitable for treatment by transarterial chemoembolization (TACE) with drug-eluting beads are included in the study. The investigators assess the response to the treatment by standard methods (RECIST, mRECIST) as well as by volumetric analysis. The size of tumor is evaluated on CT/MRI by two investigators prior to first TACE and then on all the check-ups (routinely every three months) until 31 December, 2019 or the patients' death.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of HCC by a radiologist according to the European Association for the Study of the Liver (EASL) criteria or confirmed histologically
* at least one TACE undergone at the University Hospital Brno
* initial/ closing CT (Brillance 64, Philips, Netherlands; contrast enhancement 125 mL Iomeron 400, Bracco, Germany) or MRI study (Achieva, Philips, Netherlands, SENSE XL Torso coil 16 1.5T; contrast enhancement 15 mL Primovist, Bayer, Germany)
* follow-up on or before December 31, 2019.

Exclusion Criteria:

* when the inclusion criteria are not met.
Evaluation of a Clinical Transitional Program in Autism

Clinical trial without drug, randomized: Comparison of a specific and integrative clinical protocol for young adults with autism to usual treatment. It will include both low and high-functioning participants.


Eligibility Criteria:
Inclusion Criteria:

* ASD diagnosis
* Previous follow-up by child and adolescent psychiatry department at Corporació Sanitària Parc Taulí (CSPT)

Exclusion Criteria:

- Living in a disabled residential setting
A Phase 2 Study of SYM-1219 to Treat Bacterial Vaginosis

The purpose of this research study is to test the safety and effectiveness of the oral investigational new drug, SYM-1219, for the treatment of bacterial vaginosis.

:This was a Phase 2, multi-center, prospective, randomized, double-blind, placebo-controlled study to evaluate the effectivenessand safety of SYM-1219 in women with bacterial vaginosis. Patients determined to be eligible for the study were randomized to one of the following treatments: SYM-1219 1 gram orallyas a single dose;SYM-1219 2 grams orally as a single dose;or matching placebo. Patients determined to be eligible based on the clinical assessments at the Baseline visit (Day 1) were randomized in a 1:1:1 ratio and received a singledose of the assigned study treatment on Day 1 under fasted conditions (i.e., no food 2 hours prior to or 1 hour after dosing). The centralized randomization was stratified by the number of reported episodes of BV in the past 12 months (including the current episode): 3 or fewer episodes versus 4 or more episodes. Patients were asked to complete a daily telephone questionnaire on Days1to7 and at the Test of Cure (TOC)/End of Study (EOS)visit. Patients were also contacted by telephone once on Day 8 to 10 to inquire about possible adverse events (AEs). A TOC visit was conducted between Day 21 and 30; or at EOSif the final visit was notconducted between Day 21and30

Eligibility Criteria:
Inclusion Criteria:

* Are females at least 18 years of age in good general health who are not menopausal.
* Have a clinical diagnosis of bacterial vaginosis, defined as having all of the following criteria:
* Off-white (milky or gray), thin, homogeneous vaginal discharge
* Vaginal pH ≥ 4.7
* Presence of clue cells of ≥ 20% of the total epithelial cells on microscopic examination of the vaginal saline wet mount
* A positive 10% KOH Whiff test.
* Have a Gram stain slide Nugent score ≥ 4 at the Baseline visit (Day 1)

Exclusion Criteria:

* Are pregnant, lactating, or planning to become pregnant during the study.
* Are suspected clinically (or confirmed diagnostically) of having alternative causes of vaginal symptoms including candidiasis, Chlamydia trachomatis, Trichomonas vaginalis, Neisseria gonorrhoeae or Herpes simplex.
* Have received antifungal or antimicrobial therapy (systemic or intravaginal) within 14 days prior to the Baseline visit (Day 1).
Evaluation of the Effectiveness of Breathing Control Technique on Long COVID Symptoms at the Reunion University Hospital

Despite the controversy, on October 6, 2021, the World Health Organization (WHO) recognized Long Coronavirus disease (COVID) by officially defining it: " symptoms appeared 3 months after the onset of the primary infection by the Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2), persisting for at least 2 months and which cannot be explained by any other condition ". Long COVID can affects any type of patient and has polymorphic and fluctuating symptoms over time.

The Reunion Island is a French overseas department located in the Indian Ocean accounting more than 860,000 inhabitants. It has recorded since March 11, 2020, nearly 491,825 cases of COVID-19 and 961 deaths of hospitalized patients. Reunion's population is multi-ethnic and younger than the metropolitan France's one. It also has a higher prevalence of obesity and type 2 diabetes, two serious form factors of COVID-19. This specific context makes this island a particular study site for Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) and Long COVID.

In addition, some studies have confirmed the involvement of the autonomic nervous system (ANS) in the symptomatology of Long COVID and demonstrated that patients with a Long COVID present a dysfunction of their ANS which is objectified by a reduced Heart Rate Variability (HRV). The regulation of heart rate by the ANS is strongly favored by respiration. A regular slow and deep breathing training helps to adjust the baroreflex, which connect heart rate, breathing and blood pressure. The result of this training is an induced state called "cardiac coherence" (CC).

The investigator therefore hypothesize that respiratory training to CC could "re-educate" the ANS and durably improve the symptomatology of patients with Long COVID.


Eligibility Criteria:
Inclusion Criteria:

* Patients over the age of 18,
* living in Reunion and
* having a diagnosis of Long COVID according to the World Health Organization (WHO) definition will be included in this study.
* These patients must attest to their primary infection with Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) and present a negative antigen test at the time of inclusion.

Exclusion Criteria:

Patients:

* with a chronic or disabling respiratory pathology preventing respiratory training (asthma, Chronic Obstructive Pulmonary Disease (COPD), active tuberculosis, pulmonary sequelae of COVID-19, etc.) practicing or having practiced a regular respiratory control technique (yoga, Cardiac coherence training, etc.) in the last 6 months
* taking a beta-blocker, betamimetic, anti-arrhythmic, morphine, antidepressant treatment (Escitalopram)
* having a pacemaker or severe heart disease
* Current and known pregnancy or breastfeeding woman
* with a cognitive deficit
* under guardianship/curators or under judicial protection
Internet-delivered CBT vs Internet-delivered Support and Counseling for Youth With Social Anxiety Disorder - An RCT

Social anxiety disorder among youth is highly prevalent and causes significant impairment in the lives of the affected. In spite of cognitive behavior therapy (CBT) being an effective treatment, research suggests that many young people with this disorder do not have access to good-quality CBT. Internet-delivered CBT could be an effective method to increase availability of evidence-based treatments for youth with social anxiety disorder. The primary objective of this study is to test the efficacy of internet-delivered CBT (ICBT) for youth (10 - 17 years) with social anxiety disorder. The investigators aim to conduct a randomized controlled trial with N = 101 participants. Participants will be randomized to either the active treatment arm (guided ICBT) or to a control condition (guided internet-delivered support and counseling). Follow-ups will be conducted at 3 and 12 months after post-assessment.


Eligibility Criteria:
Inclusion Criteria:

* A principal diagnosis of social anxiety disorder, as defined by DSM-5
* Age between 10 and 17 years
* Ability to read and write Swedish
* Daily access to the internet through a computer or similar device
* A parent or caregiver that is able to co-participate in the treatment
* Participants on psychotropic medication must have been on a stable dose for the last 6 weeks prior to baseline assessment

Exclusion Criteria:

* Diagnosed with autism spectrum disorder, psychosis, bipolar disorder or severe eating disorder
* Present risk of suicide
* Ongoing alcohol or substance abuse
* Occurrence of domestic violence
* Completed CBT for any anxiety disorder within the last 6 months (defined as at least 5 sessions of CBT including in vivo exposure sessions)
Recurrent ESBL-producing Enterobacteriaceae Bacteremia: Risk Factor, Molecular Character and Susceptibility Change

The purpose of this study is to investigate the risk factor, molecular character and susceptibility change for recurrent ESBL-producing Enterobacteriaceae bacteremia

1. To characterize the genotypes of the pathogens isolated from recurrent ESBL-EK bacteremia versus non-recurrent ESBL-EK bacteremia to differentiate relapse from reinfection

   * recurrent versus non-recurrent
   * relapse versus reinfection
2. To correlate the patient characteristics, clinical manifestations, severity of illness (the modified Pitt bacteremia score), diagnosis of deep-site infection, co-morbid conditions (including diabetes mellitus, hepatic and renal dysfunction), length of stay in ICU/hospitalization, the presence of invasive procedures, source of pathogen (community acquired or nosocomial infection), antimicrobial regimen (i.e carbapenems versus non-carbapenems(flomoxef or quinolones), microbiological characteristics (E coli and Kleb. pneumoniae) and outcome endpoints (clinical outcome and mortality) with ESBL recurrence and genotypes

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (age\>=18 years) with at least one episode of ESBL-EK bloodstream infection from August 2004 to July 2010

Exclusion Criteria:

* Patients who died within 48h after first episode of ESBL-EK bloodstream infection