cyrilzakka/clinical-trials huggingface dataset:
An Active Approach to Treat Amblyopia: Perceptual Learning and Video Games

Amblyopia, a developmental abnormality that impairs spatial vision, is a major cause of vision loss, resulting in reduced visual acuity and reduced sensitivity to contrast. This study uses psychophysical measures to study neural plasticity in both adults and children with amblyopia.

Amblyopia, a developmental abnormality that impairs spatial vision, is a major cause of vision loss, resulting in reduced visual acuity and reduced sensitivity to contrast. Our previous findings (see CITATIONS) show that the adult amblyopic brain is still plastic and malleable, suggesting that active approach is potential useful in treating amblyopia. The goal of this project is to assess the limits and mechanisms of neural plasticity in both normal and amblyopic spatial vision. This study uses psychophysical measures to study neural plasticity in both adults and children with amblyopia. Research participants will be asked to practice a visual discrimination task (perceptual learning) or to play video games with the amblyopic eye for a period of time. A range of visual functions will be monitored during the course of treatment.

Eligibility Criteria:
Inclusion Criteria:

* adults and children (\>5 years old) with normal vision or amblyopia
* amblyopia: interocular VA difference of at least 0.1 logMAR

Exclusion Criteria:

* any ocular pathological conditions, nystagmus
Dietary Guidelines, Portion Sizes, and Time Frame

During the last update of the French FBDG, a survey with a representative sample of dieticians investigated 1) how to communicate portion sizes and 2) the most relevant time frame when delivering dietary guidelines. The objective was to determine how to express portion sizes and time frame for Food Based Dietary Guidelines (FBDG) using the feedback of dietitians. Data were obtained from an internet-based survey of 441 French dieticians (collected from November 24, 2013 through January 2, 2014).

Background: Food Based Dietary Guidelines (FBDG) need to accessible and understandable to consumers. During the last update of the French FBDG, a survey with a representative sample of dieticians investigated 1) how to communicate portion sizes and 2) the most relevant time frame when delivering dietary guidelines.

Objective: To determine how to express portion sizes and time frame for Food Based Dietary Guidelines (FBDG) using the feedback of dietitians.

Design: Data were obtained from an internet-based survey of 441 French dieticians (collected from November 24, 2013 through January 2, 2014).

Eligibility Criteria:
Inclusion Criteria:

All members of the AFDN (French Association of Dietitians and Nutritionists) were invited to participate (n=2500 except the ones that had already participated in the pre-test n=10).

Members of the AFDN who have completed the online questionnaire were retained for analysis (n= 441).

Exclusion Criteria:

Incomplete questionnaires Participants of the pre-test (n=10)
Study Evaluating GSI-953 in Healthy Young and Alzheimer's Patients

To assess the pharmacodynamics (PD) of biomarkers amyloid beta peptide 40 and 42 (Ab40 and Ab42) in CSF, following single oral doses of GSI-953, an investigational drug, in healthy young subjects and patients with Alzheimer Disease (AD).


Eligibility Criteria:
Inclusion Criteria:

* For Healthy Young Subjects: Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs and 12 lead ECGs.
* For AD patients: Patients must be generally healthy with the exception of Alzheimer Disease. (same as above)
Study of the Effect on Clinical Outcomes Using Secure Text Messaging

In this study, the investigators will conduct a randomized, controlled trial to evaluate the impact of offering mobile secure text messaging on clinical outcomes.

Inpatient health care providers such as physicians and nurses spend up to one-third of their time communicating with other health care providers. Many of these communications have shifted mediums from handwritten notes and face-to-face conversations to phone calls and paging systems. More recently the rapid adoption of smartphones has led to the use of mobile-enabled technologies using smartphones such as text messaging and email. While these technologies may offer ease and fit better within the clinical workflow, they often send patient information through unsecure cellular or internet connections. Mobile secure text messaging may address these issues by encrypting data and allowing for asynchronous or synchronous communication between individual providers or groups of providers. In this study, the investigators will conduct a randomized, controlled trial to evaluate the impact of offering mobile secure text messaging on clinical outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Admission to one of the hospital floors or services in the study at the Hospital of the University of Pennsylvania

Exclusion Criteria:

* Discharges against medical advice
* Discharges to hospice
Interaction of Genetic and Environmental Factors for Body Fat Mass Control

Although the effect of interaction between genetic and environmental factors on body fat mass (BFM) has been proposed, how lifestyle changes affect body weight with regard to the genetic composition needs to be verified. The investigators designed an observational study, consisting of healthy adults with single nucleotide polymorphism (SNP) genotyping and longitudinal monitoring of lifestyle including food consumption and physical activities. The investigators recruited the participants who desired to control their body fat mass. Participants freely choose one of the options among carbohydrate intake reduction, fat intake reduction or exercise amount increment to control their body fat mass. Their lifelog on exercise and diet were collected, using a wearable device, for three months. Further, the investigators assessed anthropometric and serologic markers to measure the effect of participant's lifestyle modification. The investigators evaluate the influence of genetic compositions on body fat reduction induced by lifestyle change. Four different genome-wide polygenic scores (GPS) of volunteers are calculated to test the genetic effects of each modification. In this lifestyle observational study, the investigators expect to validate the interaction of genetic and environmental factors in determining BFM, and implicate the healthcare utility of lifestyle modifications using personalized and genomic perspective.


Eligibility Criteria:
Inclusion Criteria:

* Age from 19 to 65

Exclusion Criteria:

* Among those reveal to participate one who is under diabetes condition were excluded on the study.
* Pregnant women
* Participants taking weight control pills
Clinical Trial of Two Study Drinks in Detoxification of Environmental Toxicants and Carcinogens

The goal of this research is to determine if consuming one of two study drinks will help enhance the detoxification of multiple environmental toxicants and cancer causing agents, particularly in subjects who are null for glutathione-S-transferase M1 (GSTM1), glutathione-S-transferase T1 (GSTT1), or both. If our research supports this idea, this drink could be an inexpensive dietary component, which could promote good health.


Eligibility Criteria:
Inclusion Criteria:

* Adult Male or female. Participants can be smokers or non-smokers
* In good physical health
* In stable and good mental health
* Not using any medications that may affect the Nrf2 pathway
* Women who are not pregnant or nursing or planning to become pregnant
* Participants have provided written informed consent to participate in the study

Exclusion Criteria:

* Significant immune system disorders, respiratory diseases, kidney or liver diseases or any other medical disorders that may affect biomarker data as determined by the licensed medical professional
* Vital signs outside of the allotted range
* Not willing to abstain from eating cruciferous vegetables during the course of the study
Brain Iron Toxicity and Neurodegeneration - A 7T MRI Study

A longitudinal observational neuroimaging study of individuals with Early Onset Alzheimer's disease during the prodromal phase, and matched control group - Ultrahigh Field MRI study at 7T

This study aims to determine whether high resolution MRI at 7T and Quantitative Susceptibility Mapping (QSM) can demonstrate a specific pattern of iron overload in strategically important areas of brain as a sensitive marker of pathological Alzheimer's disease i.e. patients with subjective or mild cognitive impairment associated with Amyloid or tau pathological state in the cerebrospinal fluid.

Eligibility Criteria:
Inclusion Criteria:

* Ability to provide informed consent
* Patients with pathological diagnosis of Alzheimer's disease according to the National Institute on Aging and Alzheimer's Association, NIA-AA, criteria (Alzheimer's group) or cognitively normal individuals within 1.5 standard deviation of normal in all tests (control group)

Exclusion Criteria:

* Lack of mental capacity to consent to study involvement
* Not speaking English before age 5 years
* Learning disability
* Schizophrenia
* Substance misuse
* Implanted devices not certified as compatible with ultra-high field MRI (e.g. cardiac pacemaker)
* Pregnancy
Respiratory Syncytial Virus (RSV) Follow-Up Study (MK-0476-374)

This is a prospective, multicenter, observational study in participants who completed the 24-week, placebo-controlled MK-0476 Protocol 272 (NCT00076973) study of montelukast in the treatment of respiratory symptoms subsequent to RSV-induced bronchiolitis. The purpose of this study is to better understand the clinical and demographic correlates of asthma and atopic disorders in children (through the age of 6 years) with a history of severe RSV-induced bronchiolitis.


Eligibility Criteria:
Inclusion Criteria:

* successfully completed MK-0476 Protocol 272
* had RSV-induced bronchiolitis at entry into Protocol 272

Exclusion Criteria:

* had developed or had been diagnosed with any illness or congenital disorder that could be immediately life threatening
Pericapsular Nerve Group Block for Elective Hip Arthroplasty

This study examine the effect of Pericapsular Nerve Group (PENG) Block on analgesia after elective hip arthroplasty. Half of participants will receive a PENG Block with local anesthetic, while the other half will receive a PENG Block with a placebo.

Optimized analgesia is crucial for early mobilization after hip arthroplasty. Regional anesthesia, like fascia iliaca block or femoral nerve block, have limited indication because of motor blockade whereas local infiltrations analgesia have shown conflicting analgesic efficacy results in hip arthroplasty.

Pericapsular nerve group (PENG) block is a new regional anesthesia technique targeting specifically sensory nerve branches of the hip articulation. It has been originally described in hip fracture patients.

The aim of this study is to evaluate the efficacy of PENG block on analgesia after elective hip arthroplasty.

Eligibility Criteria:
Inclusion Criteria:

* Elective total hip arthroplasty
* General anesthesia
* Enhanced Recovery Program

Exclusion Criteria:

* American Society of Anesthesiologists (ASA) Score \> 2
* Drug allergy
* Significant psychiatric disturbances
* Preoperative opioid use
* Contraindication to acetaminophen, celecoxib, methylprednisolone or tranexamic acid
* Body Mass Index \> 40 kg/m²
Relationship of Brain Natriuretic Peptide (BNP) Levels to Cardiac Diagnosis, Operation Performed, Post-operative Course and Outcome

The purpose of this study is to assess brain natriuretic peptide levels to evaluate the relationship of those levels with the diagnosis of congenital cardiac disease, operation performed, post-operative course, and outcome.

Three types of natriuretic peptides (NP) have been isolated: atrial natriuretic peptide (ANP), brain natriuretic peptide (BNP), and C-type natriuretic peptide (CNP). The NP family elicits a number of vascular, renal and endocrine effects that help to maintain blood pressure and extracellular fluid volume. These effects are mediated by the specific binding of NP to cell surface receptors that have been characterized, purified and cloned from cells of the vasculature, kidney, adrenal gland and brain. There are 3 subtypes of NP receptors: type A natriuretic peptide receptor (NPRA), type B natriuretic peptide receptor (NPRB), and type C natriuretic peptide receptor (NPRC). All 3 subtypes affect cellular second messenger activity. The literature currently does not define the levels of b-type natriuretic peptide (BNP) in children with congenital heart disease undergoing surgery.

The investigator wishes to perform a retrospective chart review to define BNP levels in the pediatric cardiac defect population and to evaluate the relationship of those levels with cardiac diagnosis, operation performed, post-operative course and outcome. The investigator will collect the following information from the medical record:

* Laboratory: BNP levels, serum pH, lactic acid, Co-ox, CBC, Chemistry
* Diagnosis
* Surgical Procedure
* Incidence of re-operation
* Length of ICU Stay
* Length of Hospital Stay
* Complications
* Length of Ventilation (how many days on the ventilator)
* Medications
* Cross Clamp Time
* Bypass Time
* Echocardiogram data
* Cardiac Catheterization Data
* Vital Signs
* Monitored Hemodynamic Measures
* Final outcome (discharged or death)

Eligibility Criteria:
Inclusion Criteria:

* Congenital heart defect

Exclusion Criteria:

* Patients without congenital heart defects
Cerclage for Short Cervix in Twins

Through cervical length measurement in uncomplicated twin gestations, women with cervical length ≤ 25 mm will be approached for randomization to cerclage placement or expectant management with activity restriction and treatment of preterm labor

Pregnant women with twin gestations are screened for short cervix with transvaginal cervical length measurements as part of routine care at St. Mary's Health Center (SMHC) and Saint Louis University's (SLUCare) Physician Group. (Transvaginal cervical length measurement every 2 weeks from 16weeks/0days-23weeks/6days weeks, per hospital practice) Women pregnant with twin gestations at SMHC who meet study criteria will undergo transvaginal length screening between 16 and 24 weeks gestation. Those women with transvaginal cervical length measurements at or below 25 mm will be approached for study participation.

If a patient agrees to participate in the trial, they will be randomized in 1:1 fashion to cerclage vs. expectant management.

Participants found to have a vaginal infection by cultures performed at randomization will be treated with appropriate antibiotics per usual institutional practices

Cerclage arm:

- Macdonald cerclage placed in standard fashion: mersilene suture preferred for standardization

Expectant management arm:

- Patient is placed on activity restrictions: no heavy lifting, frequent reclining, and pelvic rest.

If a participant does not consent to participate in the trial, permission to collect their outcome information in an observational manner will be requested.

The neonatal medical record will be reviewed for outcome data on twins, weights, complications, neonatal intensive care unit (NICU) stay, to 28 day after discharge.

Eligibility Criteria:
Inclusion Criteria:

* at least 14 years of age, but less than 55 yrs of age
* must be able to read and write English
* must be able to give informed consent.
* Twin pregnancy

Exclusion Criteria:

* Women with a serious physical or mental illness or condition that would substantially interfere with participation in the study
* membrane prolapse beyond the external cervical os,
* major fetal anomaly in either twins will be excluded from randomization.
Pretreatment Aceclofenac Effect on Pain and Analgesic Intake After Endodontic Treatment

The aim of this prospective, randomized, double-blind, clinical trial is to evaluate the effect of a preoperative, single, oral dose of aceclofenac (100 mg) on postendodontic pain at 6, 24 and 48 hours, postoperative pain at injection area at 6, 24 and 48 hours and analgesic intake after single-visit root canal treatment.

* Patients will be clinically and radiographically examined and their eligibility will be assessed and preoperative pain will be measured using Heft-Parker VAS. Eligible patients will be treated in one visit.
* Patients will be randomly assigned to one of 2 groups: experimental group (taking a 100 mg of Aceclofenac) and the control group (taking a placebo tablet). Each tablet will be taken one hour before the initiation of single-visit endodontic therapy. Each participant will receive a standard inferior alveolar nerve block injection of 1.8 ml of 2% mepivacaine with 1:100,000 epinephrine. After endodontic treatment, patients will be given postoperative instructions and informed, in case of pain, to receive ibuprofen 200 mg as rescue medication.
* Postendodontic pain intensity and incidence at the different pain categories (No, mild, moderate, severe) will be assessed 6, 24, and 48 hours postoperatively using Heft-Parker visual analogue scale (HP-VAS). Postoperative pain at injection area will be assessed at 6,24 and 48 hours using HP-VAS. Analgesic intake throughout the 48 hours will be recorded.

Eligibility Criteria:
Inclusion Criteria:

* Patients in good health (American Society of Anesthesiologists Class I or Class II).
* Patients having symptomatic irreversible pulpitis in one of their mandibular molars
* Age is 18 years or older.
* Patients who can understand Heft- Parker Visual Analogue Scales.
* Patients able to sign informed consent.

Exclusion Criteria:

* Patients allergic to aceclofenac or Mepivacaine.
* Pregnant or nursing women.
* Patients having active pain in more than one molar in the same quadrant.
* Administration of analgesics within 12 h before the administration of the study drug.
A ToM Training for People With Multiple Sclerosis: an Efficacy Study.

Theory of Mind (ToM) is the ability to understand and attribute mental states to ourselves and others. People with Multiple Sclerosis (pwMS) could present an impairment of this ability, with negative consequences on their social relationships and Quality of Life (QoL). We aimed to design and implement a novel ToM rehabilitation training, testing its efficacy on the promotion of emotional and mental states understanding, on QoL and on the alexithymia traits.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of Relapsing-Remitting (RR), Secondary Progressive (SP) and Primary Progressive (PP) MS;
* age ≥ 18 and ≤ 75 years;
* years of education ≥ 5;
* no change of pharmacological treatment in the 6 months before the enrollment;
* no clinical relapses or use of steroid treatment during 3 months before the enrollment;
* provided informed consent for study participation.

Exclusion Criteria:

* history of nervous system disorders different from MS;
* unstable psychiatric illness, such as psychosis or major depression;
* severe disability with Expanded Disability Status Scale (EDSS) score \> 7.5;
* severe cognitive impairment that would not enable PwMS to answer to questionnaires correctly (i.e. dementia), according to the patient's medical records.
A Randomized, Double Blind, Parallel Group, Placebo Controlled, Multicenter Outpatient Trial Of PD 0200390 In Adults With Primary Insomnia

To demonstrate efficacy and characterize the dose response relationship of PD 0200390 on subjective wake after sleep onset in subjects with primary insomnia.


Eligibility Criteria:
Inclusion Criteria:

* 3 month history of primary insomnia;
* 18 to 64 years
* For the last 3 months-regularly awake unrefreshed and unrestored
* Difficulty initiating and maintaining sleep for at least 3 nights/week for the past month (difficulty falling asleep, difficulty staying asleep, early awakening)

Exclusion Criteria:

* Any history of an Axis 1 psychiatric diagnosis;
* History or presence of any breathing related sleep disorder;
* History or presence of any medical or neurological condition that could interfere with sleep
* Use of alcohol as a sleep aid or more than 2 standard drinks consumed per day or more than 14 consumed per week
Prospective Imaging Assessment of Perineo-pelvic Static's Evolution After Sexual Reassignment Surgery in MtF Transgender Patient, by Peno-scrotal Inversion Vaginoplasty Technique (TRANSPELV)

The research consists of adding to the usual MtF transgender patient undergoing vaginoplasty care course, static and dynamic perineo-pelvic MRI before, and at 6 and 24 months. The aim is to assess perineo-pelvic static's evolution, based on the appearance of a rectocele.

Transgender people are estimated to be about 0,3 to 1 % of general population, and MtF reassignment surgery is raising. Vaginoplasty is not always necessary, but is usually an important step into gender transition. In France, surgical techniques' gold-standard is the peno-scrotal inversion vaginoplasty, which consists in the creation of a neo-vagina with peno-scrotal skin graft. Genital, perineum and pelvic anatomy is modified, without knowing in advance about functional and aesthetic results. MRI is the best way to assess soft tissue anatomy in the pelvis. Though, only few studies have assessed pre and post-operative imaging in patients undergoing vaginoplasty, and none have been prospective, neither have assessed the risk of rectocele. The issue is legitimate, because the surgery weakens elements of pelvic fixity, and fixity issues can appear secondarily.

MtF transgender patients operated for a vaginoplasty are undergoing static and dynamic MRI before the surgery, at 6 and at 24 post-operative months. We look after the appearance of a rectocele and it's evolution in time, as criteria for the assessment of pelvic fixity.

Follow-up is composed of several consultations including post-operative MRI, but also clinical measures, census of post-operative issues, and questionnaires for the assessment of secondary objectives.

Eligibility Criteria:
Inclusion Criteria:

* Patient over 18 years old
* Patient admitted in urology ward at Limoges' University Hospital for MtF sexual reassignment surgery by vaginoplasty
* Patient affiliated or benefitting from a social security system
* Patient free, informed, written and signed consent

Exclusion Criteria:

* Patient admitted for vulvoplasty surgery
* Patient admitted for second vaginoplasty surgical gesture
* Contraindication of realizing an MRI
Attention Bias Modification for Reducing Health Anxiety During the Coronavirus Pandemic

The outbreak of the 2019 Coronavirus (COVID-19) pandemic is a major stressor leading to increased levels of anxiety, and specifically, an excessive fear of being infected and affected by the disease among major parts of the population. At the same time, the access to mental health services is limited due to the lockdown policy applied in many countries worldwide, warranting the development of home-delivered interventions aimed at reducing stress and anxiety symptoms. Attention Bias modification (ABM) has been found to be an efficacious computerized intervention to reduce anxiety symptoms. In this open pilot trial, participants reporting on elevated levels of health anxiety concerning the COVID-19 epidemic will receive one session of ABM over 5 consecutive days (5 sessions total). Symptoms of health anxiety, state anxiety, generalized anxiety, and depression will be measured at baseline and post-treatment.


Eligibility Criteria:
Inclusion Criteria:

* 3 or more symptoms (out of 7) reported in the COVID-19 anxiety inventory with a score of 4 or 5.
* Fluent Hebrew
* Having a PC computer at home with internet access

Exclusion Criteria:

* A diagnosis of dyslexia or other reading disability