cyrilzakka/clinical-trials huggingface dataset:
Study of Gesture and Executive Functions in Children With High Intellectual Potential

The main objective of this study is to determine whether children with high intellectual potential have gestural and / or executive difficulties compared to control children.


Eligibility Criteria:
Inclusion Criteria:

All participants :

* Informed consent of the child and both parents obtained
* Affiliated to Social Security
* Participants must be between 6 and 16 years of age.

Child with high intellectual potential :

* Score ≥ 130 on an intellectual efficiency scale administered by a psychologist

Control child :

* They will have to be intellectually efficient in the standard. To ensure this, the two sub-tests of the Intellectual Efficiency Scale (WISC-V) most closely correlated with intelligence (Vocabulary and Matrices) will be administered to them. Thus, the child must meet one of the following criteria in order to be included:
* Have two standard notes between -1 and +1 DS (between 7 and 13);
* Have one of its two notes between -1 and + 1DS (between 7 and 13) and the other between -2DS and \<+ 2DS (between 5 and 15).

Exclusion Criteria:

All participants :

* Neurological history (epilepsy, cranial trauma, prematurity ...)
* Psychiatric history (Autistic Spectrum Disorder ...),
* Known genetic disease,
* Motor deficiency (eg hemiplegia),
* Elementary sensory disorder (auditory and visual) or insufficient command of French, limiting the understanding and participation in the study likely to impact the results to the protocol.
* Gnosic visual or linguistic deficiency.
* Sensory disorder
* Psychotropic Intake

Control child :

* High intellectual potential
* Known or suspected learning disability (no dyslexia-dysorthography, dysphasia, dyspraxia, dyscalculia).
Cortical Priming to Optimize Gait Rehabilitation in Stroke: a Renewal

Achieving functional ambulation post stroke continues to be a challenge for stroke survivors, clinicians, and researchers. In the effort to enhance outcomes of motor training, cortical priming using brain stimulation has emerged as a promising adjuvant to conventional rehabilitation. This project focuses on the development of a long term gait rehabilitation protocol using brain stimulation to improve walking outcomes in people with stroke. The project will also aim to understand the neural mechanisms that are associated with response to the intervention.


Eligibility Criteria:
Inclusion Criteria:

* Age greater than 18 years
* First ever monohemispheric stroke \> 3 months since onset
* Residual hemiparetic gait deficits (e.g. abnormal gait pattern)
* Able to walk for 5 minutes at self-paced speed. Handheld assistive device is acceptable.
* Walking speed lesser than 1.2 m/s
* Lower limb Fugl-Meyer Motor score between 15-30
* At least 5 deg of ankle dorsiflexion necessary to perform the ankle-tracking task

Exclusion Criteria:

* General exclusion criteria

  * Severe osteoporosis
  * Contracture-limiting range of motion of lower limb
  * Score of more than 2 on the Modified Ashworth Scale (indicating increased muscle tone through ankle range of motion)
  * Uncontrolled anti-spasticity medications during the study period
  * Score less than 6 on the Fugl-Meyer Sensory Assessment Scale for the Lower Limb
  * Cardiorespiratory or metabolic diseases (e.g. cardiac arrhythmia, uncontrolled hypertension or diabetes, chronic emphysema)
  * Unhealed decubiti, persistent infection
  * Significant cognitive or communication impairment (Mini-Mental State Examination (MMSE)\<21), which could impede the understanding of the purpose of procedures of the study or prevent the patient from performing the ankle-tracking task.
  * Lesions involving the brainstem and cerebellum
  * Failure to pass the graded exercise stress test

TMS exclusion criteria

* Implanted cardiac pacemaker
* Metal implants in the head or face
* Unexplained, recurring headaches
* History of seizures or epilepsy
* Currently under medication that could increase motor excitability and lower seizure threshold
* Skull abnormalities or fractures
* Concussion within the last 6 months
* Currently pregnant

tDCS exclusion criteria

* Skin hypersensitivity
* History of contact dermatitits
* History of allodynia and/or hyperalgesia
* Any other skin or scalp condition that could be aggravated by tDCS
Impact of an Intensive Monitoring Strategy in Symptomatic Patients With Suspected Arrhythmia

Hypothesis:

Patients that were previously discharged from the emergency department with a subsequent non-diagnostic 30 day external patch monitor for suspected arrhythmia will benefit from early Reveal LINQ™ Insertable Cardiac Monitoring System placement.

Primary Study Objectives:

To evaluate the outcome of an intensive monitoring strategy (patients with a negative 30 day SEEQ™ Mobile Cardiac Telemetry (MCT) System result are purposed over for a Reveal LINQ™ Insertable Cardiac Monitoring System) in patients with suspected but no previously documented arrhythmias that result in a clinically actionable event.

Eligible patients will be enrolled after presentation to the Emergency Department of St. Elizabeth Healthcare with symptoms suggestive of cardiac arrhythmia and prior to leaving the emergency department. Patients will be exited from the study and considered complete at the identification of a cardiac arrhythmia as defined in the protocol (endpoint), or 12 months from enrollment date, whichever occurs first.

Protocol defined endpoints

1. Planned insertion of a permanent pacemaker, implantable cardiac defibrillator or chronic resynchronization device.
2. Planned cardiac ablation procedure.
3. Initiation of medical therapy for the purpose of treating dysrhythmia.
4. Diagnosis of arrhythmia not requiring medical or invasive arrhythmia management.

Eligibility Criteria:
Inclusion Criteria:

* \>18 years of age
* Patient present to the ED with symptoms suggestive of cardiac arrhythmia
* English is the patient's primary language
* Willing and able to provide consent for participation in the study
* Patient is willing and able to comply with the protocol including the required follow-up

Exclusion Criteria:

* Refusal to participate
* Age \< 18 years of age
* Unable to provide consent
* Current implanted loop recorder, or loop recorder explanted within the past 12 months.
* Current implant of cardiac implantable electronic device, such as permanent pacemaker (PPM), implantable cardioverter defibrillator (ICD), or cardiac resynchronization therapy (CRT) device.
* Life expectancy \< 12 months
* History of prior cardiac ablation or electrophysiology study for suspected arrhythmia
* Investigator decision related to serious comorbidities or identification of reversible cause
* Unable to comply with follow-up procedures
* Previous documented diagnosis of cardiac arrhythmia by holter monitor, event monitor, ECG.
* Currently taking antiarrhythmic medication for a previously documented cardiac arrhythmia
* History of or suspected diagnosis of Postural Orthostatic Tachycardia Syndrome (POTS)
* Patient has unusual thoracic anatomy that precludes proper SEEQ patch placement
* Patient is enrolled in another study that could confound the results of this study
Cervical Cancer Screening in Madagascar Using Smartphone Photos and Mobile Telemedicine

The purpose of this study is to determine whether smartphone photos may assist health-care worker (on-site) and to evaluate the diagnostic reliability and accuracy of cervical examination with smartphone photos of VIA (D-VIA), on-site and off-site, compared with conventional VIA, for human papillomavirus (HPV) positive women.

Background: Cervical cancer is the leading cause of cancer death in females in Madagascar. In this country, a large-scale screening of precancerous lesions with cytology is hardly possible, because of the lack of specialists and infrastructures. Visual inspection of the cervix with application of 5% acetic acid (VIA) is an inexpensive alternative but very subjective since it depends on the examiner's experience. Mobile telemedicine is a very promising tool in order to assist non-expert health-care workers in rural area for cervical cancer screening.

Objective: To assess if Smartphone may assist health-care worker (on-site) and to evaluate the diagnostic reliability and accuracy of cervical examination with smartphone photos of VIA (D-VIA) compared with conventional VIA, for women testing positive for human papillomavirus (HPV).

Material and method: On-site health care workers will be trained in VIA. Prescreened HPV-positive women will be referred to VIA evaluation, during which digital images with a smartphone (D-VIA) will be taken for later evaluation by a VIA specialist in Geneva linked by telemedicine. Women with positive VIA results will be treated with cold coagulation if eligible. Histological results will be considered as gold standard. The results will be analyzed with Cohen's kappa coefficient, Mcnemar's test and Bonferroni's adjustment for multiple comparisons to assess the performance of D-VIA.

Expected results: Based on the results of this project, the investigators will develop an educational training and quality assurance program for health providers for VIA and so contribute to a scaling-up of cervical cancer control. An appropriate triage by VIA will reduce not only an excessive referral rate but also an excessive treatment delay, giving the possibility of a "screen (HPV), see (VIA/D-VIA), and treat" program in a single or two visits.

Eligibility Criteria:
Inclusion Criteria:

* 30-49 years
* HPV-positive
* Attending the cervical cancer screening program conducted by the Saint-Damien Health-Care Centre
* Understands study procedures and accepts voluntarily to participate by signing the informed consent form (ICF)

Exclusion Criteria:

* Previous Hysterectomy
* Conditions that can interfere with visualization of the cervix
* Pregnancy \> 20 weeks
* Not able to comply with protocol study.
Macular Retinoschisis and Detachment Associated With Glaucomatous Optic Neuropathy

Clinical features, optical coherence tomography findings and surgical outcome in eyes with macular retinoschisis and detachment with normal tension glaucoma but without optic disc pit or high myopia were evaluated.


Eligibility Criteria:
Inclusion Criteria:

* The patients with macular retinoschisis and detachment associated with normal tension glaucoma

Exclusion Criteria:

* Optic pit maculopathy, high myopia
Sleep Positional Trainer for Positional Sleep Apnea After Mandibular Advancement Device (MAD) Therapy

The investigators will perform a clinical trial comparing mandibular advancement device (MAD) therapy with sleep positional trainer (SPT) and the combination of MAD and SPT in patients with positional sleep apnea using MAD. Patients are invited for 2 consecutive polysomnographies (PSGs) in randomized order: one PSG with SPT, one PSG with SPT and MAD. PSGs are performed at the Antwerp University Hospital.


Eligibility Criteria:
Inclusion Criteria:

* patients with supine dependent Obstructive Sleep Apnea (OSA) after Mandibular Advancement Device (MAD) Therapy: Apnea Hypopnea Index (AHI) supine ≥ 2x AHI non supine
* 5 \< AHI \< 50/h sleep on polysomnography (PSG) with MAD in situ
* ≥ 20% supine position during PSG with the MAD in situ
* AHI non-supine \< 10/h en AHI supine ≥ 10/h on PSG with MAD in situ
* Unchanged Body Mass Index (BMI)(BMI ± 1 kg/m²) at moment of inclusion compared to BMI at baseline PSG

Exclusion Criteria:

* age \< 18 years
Epidemiology of Depression and Heart Failure in Aging

To understand how depression leads to congestive heart failure (CHF) in older adults.

BACKGROUND:

Depression is known to be associated with an increased risk of coronary heart disease (CHD), and with adverse outcomes among older adults with CHD. Recent evidence suggests that depression is also associated with an increased risk of congestive heart failure, and with adverse outcomes among older adults with congestive heart failure. However, the mechanisms by which depression leads to congestive heart failure are not known

DESIGN NARRATIVE:

To determine the mechanisms of association between depression and CHF, the investigators will use an existing cohort of 1024 older adults (mean age 67) with CHD (including 680 with no heart failure and 344 with clinical or subclinical heart failure) who were recruited between September 2000 and December 2002 for "The Heart and Soul Study." The Heart and Soul Study was originally designed to understand the mechanism of association between depression and CHD. Since patients with CHD are at high risk for CHF, this well-characterized cohort will provide a unique opportunity to examine the relation between depression and CHF. At baseline, participants completed a depression interview (Diagnostic Interview Schedule); full exercise treadmill testing with stress echocardiography; 24-hour Holter monitoring for heart rate variability; 24-hour urine collection for cortisol and norepinephrine; venous blood measurements for lipids, platelet reactivity, and C-reactive protein; and an extensive questionnaire. Participants have been followed annually by telephone. The investigators will invite all participants to return for a 5-year examination, and will follow them for an additional 3 years thereafter, to determine (a) the independent association between baseline depression and CHF, and (b) the extent to which 5-vear changes in biological and behavioral factors associated with depression explain the relation between depression and CHF. By identifying the mechanisms that explain the relation between depression and CHF, this study will enable them to target specific areas for improving the treatment of these patients.

Eligibility Criteria:
No eligibility criteria
Prucalopride in Paediatric Subjects, With Functional Faecal Retention

The purpose of this study is characterize the efficacy, safety, tolerability, and steady-state plasma levels after once-daily oral dosing of prucalopride (R108512) as a solution, 0.01 mg/kg to 0.03 mg/kg, given to paediatric subjects with functional faecal retention (FFR) for 8 weeks.

Hypothesis:

Pharmacokinetic profile of prucalopride in paediatric subjects is expected to resemble the adult pharmacokinetic profile. Safety and tolerability profile are expected to resemble the adult profile.

This is a multicentre, open-label trial in which paediatric subjects (ages 4 to 12 years) with FFR were administered prucalopride in oral solution once daily for 8 weeks. Subjects who entered this extension trial had completed PRU-USA-12, a single-dose pharmacokinetic trial, usually within the previous week.

Evaluations for efficacy, safety and tolerability were performed, and plasma samples for analysis of prucalopride levels were obtained at 2, 4, 6 and 8 weeks.

The initial dosage of prucalopride oral solution was 0.02 mg/kg/day. Dependent on the subject's response, the parent could adjust the dosage within a range of 0.01 mg/kg/day to 0.03 mg/kg/day.

Eligibility Criteria:
Inclusion Criteria:

* Subject completed the PRU-USA-12 pharmacokinetic trial
* Subject bowels had been "cleaned-out" (ie, any faecal impactions removed)
* Written informed consent, signed by the subject's legal guardian and by the investigator
* Subject assent documented in the form of a note-to-file in the subject's source documentation

Exclusion Criteria:

• No exclusion criteria
Modifying Whey Protein Fortified Drinks and Foods

This study aims to investigate whether consumers differ in mouthdrying sensitivity and if mouthdrying can be modulated.

1. To investigate whether older adults are more sensitive to whey protein derived mouthdrying compared with younger adults
2. To investigate whether increasing fat levels in a solid whey protein model influences mouthdrying perception

Eligibility Criteria:
Inclusion Criteria:

* Age (18-30 years or over 65 years)
* Healthy

Exclusion Criteria:

* Relevant food allergies or intolerance
* Outside age criteria
* Diabetic
* Had oral surgery
* Had a stroke
* Smoker
* Cancer Taking prescribed medication that could influence study outcomes Anyone who currently has COVID-19 symptoms or who has had COVID-19 within the last 4 weeks
Distinction Between Lung Cancer and Gynecological Cancers by Canine Scent Detection

Previous studies have shown that specially trained sniffer dogs are capable to discriminate breath samples of patients with lung cancer and healthy individuals. So far it is not known whether this differentiation is specific for lung cancer or just identifies any form of (solid) tumor. Therefore, the dog's ability to differentiate between lung cancer, breast cancer and ovarian cancer is tested.


Eligibility Criteria:
Inclusion Criteria:

* histologically confirmed lung or breast or ovarian cancer

Exclusion Criteria:

* other cancers
* previous medical intervention within the last 14 days before gathering of the breath sample
Chronic Low Back Pain Rehabilitation in Primary Care: a Pilot Study

Up to now, only little research has been performed in tailoring treatment of patients with chronic low back pain (CLBP). It would be interesting to evaluate a biopsychosocial intervention in patients with a moderate to high level of disability and in whom the contributing role of psychosocial factors to this disability is mild to moderate (WPN3-). Nowadays, these patients receive cognitive behavioral-based treatments in multidisciplinary rehabilitation settings but might also benefit from treatments based on these multidisciplinary rehabilitation treatment principles when provided by specifically trained primary care physical therapists. Therefore, the aims of this pilot-study are to evaluate the feasibility of a specifically for primary care physiotherapist developed biopsychosocial intervention ("Back on Track" intervention) in WPN3- classified patients, and to evaluate whether this "Back on Track" intervention results in a significant improvement in functional disability in this subgroup of patients.


Eligibility Criteria:
Inclusion Criteria:

* Chronic low back pain; defined as pain between scapulae and gluteal region, whether or not with radiation towards one or both legs, present for at least three months.
* Presence of contributing social and psychological factors, however not complex (WPN3-classification).
* Age between 18 and 65 year
* Sufficient knowledge of the Dutch language
* Acceptance towards the biopsychosocial approach instead of biomedical approach

Exclusion Criteria:

* Chronic low back pain attributable to e.g. infection, tumour, osteoporosis, fracture, structural deformation, inflammatory process, radicular syndrome or cauda equina syndrome
* Pregnancy
* Any suspicion of an (underlying) psychiatric disease, for which psychiatric treatment is better suited, according to the expert opinion of the consultant in rehabilitation medicine.
Comparison of Two- Versus Three-antibiotic Therapy for Pulmonary Mycobacterium Avium Complex Disease

NTM therapy consists of a multi-drug macrolide based regimen for 18-24 months. Treated patients frequently experience debilitating side effects, and many patients delay the start of antibiotic treatment due to these risks. Common side effects include nausea, diarrhea, and fatigue, and rare but serious toxicities include ocular toxicity, hearing loss, and hematologic toxicity. To date, most of the evidence underlying the current treatment recommendations has come from observational studies in which either a macrolide has been combined with rifampin and ethambutol, or in some cases combined with ethambutol alone. The proposed study will answer whether a third drug is necessary or whether taking two drugs can increase tolerability without a substantial loss of efficacy.

Mycobacterium avium complex (MAC) are a subset of nontuberculous mycobacteria (NTM), environmental bacteria that can cause chronic, debilitating pulmonary disease, primarily affecting those over age 60. The goals of treatment are to improve symptoms, stop disease progression, and clear the infection. We propose to address a longstanding controversy in the therapy of pulmonary MAC disease, whether patients must take three antibiotics concomitantly, or if two are sufficient. The study is a multicenter randomized pragmatic clinical trial to compare azithromycin + ethambutol (2-drug therapy) vs. azithromycin + ethambutol + rifampin (3-drug therapy) for non-cavitary pulmonary MAC disease. All clinical outcomes will be considered standard of care and abstracted from clinical records. Therapy changes and adverse events will be recorded at routine visits. Health-related quality of life (HRQoL) and self-reported toxicity will be captured centrally in a web-based database, and CT scans will be read centrally. Co-primary outcomes are culture conversion and tolerability of treatment. The primary analysis for culture conversion will be conducted as a per-protocol non-inferiority analysis, and the primary analysis for tolerability will be conducted as an intention-to-treat superiority analysis.

Eligibility Criteria:
Inclusion Criteria:

* Culture positive pulmonary MAC meeting ATS/IDSA disease criteria
* Age over 18 years
* Ability to provide informed consent

Exclusion Criteria:

* Fibrocavitary disease
* Planned surgery for MAC disease
* Patients who have cumulatively taken 6 weeks or more of multi-drug antimicrobial treatment for MAC
* Patients who are currently taking or have taken multi-drug antimicrobial treatment for NTM within the prior 30 days
* Diagnosis of Cystic fibrosis
* Diagnosis of HIV
* History of solid organ or hematologic transplant
* Significant drug-drug interaction not clinically manageable in the opinion of the investigator
* Contraindication to any component of the study treatment regimen