cyrilzakka/clinical-trials huggingface dataset:
A Rollover Study for Subjects Who Completed Participation in the VRX496-USA-05-002 Trial

The objective of this study is to determine the long term safety and tolerability of an additional infusion of 10 billion VRX496 gene-modified CD4 T cells with a focus on evaluating additional therapeutic benefits with respect to viral load and CD4 counts.

The study has concluded it's 9-month active phase. Subjects are currently in a 15-year Long Term Follow-up Phase of the study.

In keeping with the recently released Guidance on Monitoring For Delayed Adverse Events, that states that for the first 5 years all subjects should undergo monitoring of vector sequences every 6 months, subjects will visit the clinic at a maximum of 6 months intervals for a blood test evaluating persistence of vector sequences.

Therefore for the first 5 years, subjects will have 6 months visits for safety assessment. For years 6 to 15, subjects will be contacted by phone or mail. At these contacts, subjects will be asked about their health status.

Eligibility Criteria:
Inclusion Criteria:

* Ability and willingness to give written informed consent in accordance with institutional and federal guidelines and to comply with the investigational nature of the study and the related requirements.
* Subjects who have successfully completed participation in the VRX496-USA-05-002 trial.
* Subjects who initiated or changed to a new ARV regimen more than 3 months prior to Entry Assessment are eligible.
* Subjects that who (1) if on ARVs and are willing to continue on the current therapy unchanged, or (2) if not on ARV willing to remain off ARVs for the duration of the trial i.e. 9 months. However, if there is clinical need to start or change ARV therapy, then it is permitted to do so.

Exclusion Criteria:

* CD4 counts decreased by ≥25% from baseline in main study.
* Viral load increased by ≥ 1.0 log from baseline in main study or ≥ 200,000.
* Female subjects who are of reproductive potential who have a positive serum B HCG at the Entry Assessment visit or are not willing to use a reliable method of barrier contraception.
* Are breast-feeding.
* Subjects who are actively using injection drugs or other substance abuse (such as extensive alcohol or narcotic use).
* Any medical condition(s) which, in the opinion of the investigator, would interfere with the subject's ability to participate in or adhere to the requirements of this protocol
* Active HIV-related or non HIV-related illness
* Subjects who do not have additional cell product available
Effect of Motor Cortex Versus Sacral Magnetic Stimulation in Multiple Sclerosis Patients With Urinary Tract Dysfunction

This work is intended to assess the effect of repetitive magnetic stimulation on the sacral roots versus repetitive magnetic stimulation on motor cortex in multiple sclerosis patients with the lower urinary tract dysfunction.

Twenty Multiple sclerosis patients with lower urinary tract symptoms will be receiving repetitive magnetic stimulation on sacral roots. Another twenty Multiple sclerosis patient with lower urinary tract symptoms will be receiving repetitive magnetic stimulation on motor cortex. Treatment outcome will be assessed and compared between the two groups.

Twenty trains of 50 stimuli at 5 Hz (train duration: 10 seconds) separated by a 40-second pause were delivered for a total of 1000 pulses (total duration: 16 minutes) once a day for four consecutive days for two weeks.

Eligibility Criteria:
Inclusion Criteria:

* Multiple Sclerosis patients (diagnosed by McDonald criteria 2010) with lower urinary tract dysfunction
* Adults more than 18 years
* Unresponsiveness to medical treatment
* Urodynamic diagnosis of detrusor overactivity and/or detrusor underactivity and/or detrusor-sphincter dyssynergia

Exclusion Criteria:

* Urinary tract infections
* Pregnancy
Dexmedetomidine to Lessen Intensive Care Unit (ICU) Agitation

The primary aim of the DahLIA trial is to determine, in patients with ICU-associated delirium and agitation who are otherwise pathophysiologically stable (as defined), the number of ventilator-free hours in the incident ICU admission in the 7 days following commencement of trial medication, in patients randomised to receive dexmedetomidine or placebo while receiving all other aspects of standard care.

The null hypothesis assumes no difference in the median number of ventilator-free hours in this ICU admission in the following 7 days, between patients receiving dexmedetomidine and placebo for ICU-associated agitation and delirium.


Eligibility Criteria:
Inclusion Criteria:

Patients will be eligible for the study if, in the opinion of the treating clinician, they continue to require mechanical ventilation only because their degree of agitation requires such a high dose of sedative medication (midazolam or propofol, the only commonly used specific sedatives in our unit) that extubation is not possible, AND in the opinion of their treating intensivist their agitation is so severe as to make lessening their sedation unsafe.

These criteria will be objectively quantified as follows:

* they have required either mechanical restraint and/or anti-delirium or sedative medication in the 4 hours prior to seeking consent AND
* their Confusion Assessment Method for the ICU (CAM-ICU) test is positive for delirium in the 4 hours prior to seeking consent AND
* their Motor Activity Assessment Scale (MAAS) score is 5 or more in the 4 hours prior to seeking consent, confirming psychomotor agitation AND
* their SOFA score is less than or equal to 5 in the 4 hours prior to seeking consent, predicting a mortality or around 5%.

Exclusion Criteria:

* Age less than 18 years old
* Pregnancy or breastfeeding
* Advanced dementia (in the premorbid state requiring professional nursing care)
* Open or closed head injury
* Death is deemed imminent and inevitable
* The patient has previously been enrolled in the DahLIA study
* Patients who could not be extubated, or who would be intubated within the following 48 hours, even if delirium or agitation were corrected. This will include:

  * Patients receiving high dose opioid for analgesia (not sedation) ( \> 40 mg/morphine/day)
  * Patients shortly to return to the operating theatre
  * Patients undergoing repeated invasive procedures, in whom it is desirable to maintain deep sedation
  * Patients likely to require ongoing airway protection or control, or ventilatory support (for example, spinal patients with an inadequate vital capacity)
* Known allergy to haloperidol or alpha 2 agonists
Desloratadine 5, 10 and 20mg in Patients With Cold Urticaria

The primary objective of the study is to assess the dosis of DL which is sufficient to inhibit cold urticaria symptoms.

A total of 30 patients (male and female) with ACU will be included in this study

Eligibility Criteria:
Inclusion Criteria:

* Informed consent signed and dated
* Reliable method of contraception for both women of childbearing potential as well as man during the study and 3 months thereafter. A highly effective method of birth control is defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomised partner
* Outpatients with ACU for more than 6 weeks. Urticaria symptoms must comprise wheal and itch.
* Age between 18 and 75 years

Exclusion Criteria:

* Subjects who are inmates of psychiatric wards, prisons, or other state institutions. Existing or planned placement in an institution after ruling according to § 40 passage 1 number 4 AMG (Arzneimittelgesetz).
* The presence of permanent severe diseases, especially those affecting the immune system, except urticaria and cold urticaria
* The presence of permanent gastrointestinal condition which may influence the oral therapy (chronic diarrhoea diseases, congenital malformations or surgical mutilations of gastrointestinal tract)
* History or presence of epilepsy, significant neurological disorders, cerebrovascular attacks or ischemia
* History or presence of myocardial infarction or cardiac arrhythmia which requires drug therapy
* Evidence of severe renal dysfunction
* Evidence of significant hepatic disease (liver enzymes twice the upper reference value)
* History of adverse reactions to DL
* Presence of active cancer which requires chemotherapy or radiation therapy
* Presence of alcohol abuse or drug addiction
* Intake of oral corticosteroids within 14 days prior to screening visit
* Use of depot corticosteroids or chronic systemic corticosteroids within 21 days prior to screening visit
* Use of systemic immunosupressants/immunomodulators like ciclosporine A, dapsone, methotrexate, mycophenolate, chloroquine, and comparable drugs within 28 days prior to screening visit.
* Pregnancy or breast-feeding
Enhancing Children's Cognitive Function and Achievement Through Carotenoid Consumption

The aim of this study is to test the casual relationship between carotenoid supplementation, cognitive function, and achievement over a school-year. The central hypothesis is that, relative to the waitlist placebo group, children receiving the carotenoid supplement will exhibit greater gains in cognitive function and achievement.

This clinical trial will be a randomized placebo-controlled double-blind trial to examine the effects of carotenoid supplementation on cognitive control, hippocampal-dependent relational memory, and academic achievement among pre-adolescents over one school year (i.e. 9-months).

Eligibility Criteria:
Inclusion Criteria:

* Child assent and parent/guardian consent
* 8-10 years of age
* No lutein supplementation within 6-months prior to enrollment (exception of multivitamins containing less than 1 mg lutein/day)
* Absence of learning disability (parent-reported)
* Tanner scale score ≤ 2
* 20/20 or corrected vision

Exclusion Criteria:

* Non-assent of child or non-consent of guardian
* Above/below 8-10 years of age
* Lutein supplementation within 6-months prior to enrollment (including multivitamins containing more than 1 mg lutein/day)
* Identified learning disability (parent-reported)
* Tanner scale score \> 2
* Not 20/20 or uncorrected vision
Safety Study of Dexmedetomidine in Elderly Under General Anesthesia

The purpose of this study is to find out appropriate dose range of dexmedetomidine to provide the elderly patients satisfactory sedation and analgesia with stable hemodynamics during perioperative period of hip replacement under general anesthesia.

All patients will be screened to determine eligibility for study entry, and the patients who meet the eligibility requirements will be informed about the study and potential risks. After giving written informed consent, the patients will be randomized into different doses of dexmedetomidine groups and the comparative groups in a same ratio.

Eligibility Criteria:
Inclusion Criteria:

* age ≥65yr, American Society of Anesthesiologists (ASA) physical status scale grade I-III, ready for HP; body weight between 45 and 75kg, body mass index (BMI) between 18 and 24kg/m2;
* the health conditions generally well according to medical history, physical examination, and laboratory tests;
* no signs of difficult intubation;
* no history of dementia and mental problems;
* normal cognitive function, ability to understand and comply with study procedures.

Exclusion Criteria:

* Age \<65 yr or \>90 yr; BMI greater than 24 kg/m2; ASA grade higher than III;
* Heart failure, severe arrhythmias, severe bradycardia (heart rate less than 40 beats/min), atrioventricular block of degree 2 or above, sick sinus syndrome, systolic blood pressure (SBP) ≥180 or \<90 mmHg, diastolic blood pressure (DBP) ≥110 or \<60 mmHg;
* Severe liver or kidney dysfunction, severe infection, and other pathological conditions that interfere with study results.
* Dementia, cerebrovascular accidents within 3 months, mental illness, epilepsy, and other adverse events that interfere with study results.
* Patients with the conditions that block communication and preoperative assessment, such as serious hearing or visual impairment;
* History of chronic analgesic use, long-term psychotropic medication use, alcohol or drug addiction.
High Power Short Duration Radiofrequency Ablation of Atrial Fibrillation Using the QDOT MICRO™ Catheter

Atrial fibrillation (AF) is the most common cardiac arrhythmia worldwide, characterized by rapid and disorganized atrial activation leading to an irregular heart rhythm. Pulmonary vein isolation (PVI) ablation is the gold standard for catheter ablation based therapy. However, recurrence of AF after PVI is common, often due to the inability to create durable ablation lesions surrounding the pulmonary veins (PV). Conventional radiofrequency (RF) ablation is typically performed with power set at 30-40 Watt for a duration of 20-30 seconds. Previous studies have shown that ablation with very higher power and shorter duration (vHPSD, 90W/4sec) may result in more continuous and more durable ablation lesions with a similar safety profile as compared to conventional ablation lesions. This new technique may consequently improve outcomes of RF ablation for AF. Moreover, HPSD ablation of AF may significantly reduce RF duration, which could lead to shorter anaesthesia, fluoroscopy and procedure duration.

Cardiac magnetic resonance imaging (CMR) enables studying cardiac volumes, function and atrial tissue characteristics. By applying this imaging strategy before ablation, and directly (\<72 hours) and later (3 months) after ablation, transient (edema) and persistent (fibrosis) effects of RF ablation in the left atrial wall and surrounding tissues may be visualized and quantified.

The Q-POWER study aims to assess the effects of VHPSD RF ablation on 1) procedural characteristics, 2) acute and long-term ablation lesion formation and collateral tissue damage as assessed by CMR and 3) clinical outcomes in AF patients.


Eligibility Criteria:
Inclusion Criteria:

* \>18 years of age
* AF and eligible for index PVI according to current ESC guidelines

Exclusion Criteria:

* Unwilling or unable to give written informed consent
* Prior left atrial ablation
* Other left atrial arrhythmias including atrial flutters
* Prior left atrial surgery
* Severe mitral valve regurgitation
* Contraindication for gadolinium-based contrast agents
* Contraindications for CMR (including metallic implants, cochlear implants, cardiac devices, neurostimulation systems, claustrophobia)
* Renal insufficiency (eGFR \< 30 ml/min)
Integration of the Therapeutic Workplace in Drug Court

Drug Courts were developed as a therapeutic alternative to incarceration of drug-involved offenders by providing 'judicially supervised' drug abuse treatment and probation for nonviolent offenders in lieu of criminal prosecution and incarceration. Outcome studies have shown that drug courts have modest effects on participation in drug abuse treatment, drug use, and employment. The Therapeutic Workplace intervention is an effective employment-based treatment that integrates abstinence reinforcement contingencies in a work setting, intended to treat individuals with histories of drug addiction and chronic unemployment. Under this intervention, drug abuse patients are hired and paid to work. To promote abstinence, patients are required to provide drug-free urine samples to gain and maintain daily access in the workplace. In this way, patients can work and earn salary, but only as long as they remain drug abstinent. Patients using drugs and lacking job skills participate in an initial training phase to initiate abstinence and establish computer data entry skills. Once abstinent and skilled, patients are hired into an income-producing Therapeutic Workplace data entry business. Given that many drug court participants suffer from long histories of drug addiction and unemployment, the Therapeutic Workplace could be ideal for this population. This proposes of this clinical trial is to evaluate the Therapeutic Workplace intervention in a Drug Court.


Eligibility Criteria:
Inclusion Criteria:

* Enrolled in Drug Court
* Report using any opiates and/or cocaine during 30 days prior to their arrest
* Unemployed

Exclusion Criteria:

Individuals are excluded if they:

* Are at imminent risk of suicide
* Have a psychotic disorder that may limit their workplace functioning or their ability to provide informed consent
Characterize the Links Between Sleep, Emotional Dysregulation and Learning in Neurodevelopmental Disorders.

The aim of this protocol is to disentangle the links between symptoms of emotion dysregulation, sleep disorders and cognitive deficits by measuring the effects of an emotional induction task on childrens' sleep with autism spectrum disorders (ASD) and attention deficit hyperactivity disorder (ADHD).


Eligibility Criteria:
Inclusion Criteria:

* Subjects aged 7 to 12
* Able to receive clear, age-appropriate information and to participate fully in the study
* Whose legal representative(s) are able to understand the objectives and risks of the research and to give their dated and signed informed consent.
* Subjects benefiting from a social health insurance plan (beneficiary of the legal representative(s))
* With a diagnosis made prior to inclusion of Autism Spectrum Disorder (ASD) or Attention Deficit Disorder with or without Hyperactivity (ADHD) as defined by Diagnostic and Statistical Manual 5 (DSM-5).
* With abbreviated intelligence quotient \> 80 measured by Wechsler Intelligence Scale for Children version IV (WISC-IV )no more than 6 months prior to research inclusion
* No diagnosis of: fragile X syndrome, Rett syndrome, trisomy 21, tuberous sclerosis of Bourneville, von Recklinghausen disease, Cytomegalovirus encephalitis (CMV encephalitis), congenital rubella, phenylketonuria
* No clinically significant abnormality which, in the investigator's opinion, could interfere with the implementation of the study.

Exclusion Criteria:

- Current or past neurological problem(s) (e.g. stroke, epilepsy, meningitis, head trauma with loss of consciousness of more than 15 min, concussion, brain tumor, ...).

tumor, ...)

* Transmeridian travel (\> 2 time zones) in the month prior to study inclusion
* Presence of a mood disorder (bipolar disorder or depression) according to DSM-5 criteria
* Social jet-lag \> 2 hours (mid-point of sleep differential during weekends vs. weekdays)
* Modification of psychotropic medication in the 2 months prior to inclusion
* Use of melatonin-based dietary supplement(s)/medication(s) in the 24 hours prior to study inclusion
* Use of psychostimulant(s) within 48 hours of study entry
* Extreme chronotype (Morningness/Eveningness questionnaire score \< 10 or \> 42)
* Cognitive-behavioral therapies (CBT) targeting sleep disorders
* Participation in research involving an experimental drug which may interfere with the protocol\*.
* Minor under guardianship
* Subject in a period of exclusion (determined by a previous or current study)
* Subject in emergency situation
Performance of an Investigational Blood Glucose Monitoring System in a Clinical Setting

The purpose of this study is to evaluate the performance and acceptability of an investigational blood glucose monitoring system, which includes meter and sensor strip.


Eligibility Criteria:
Inclusion Criteria:

* Males and females, 18 years of age and above
* Type 1 or type 2 diabetes
* Currently self-testing blood glucose at home at least twice daily
* Able to speak, read, and understand English
* Willing to complete all study procedures

Exclusion Criteria:

* Currently Pregnant
* Hemophilia or any other bleeding disorder
* Employee of competitive medical device company
* Cognitive disorder or other condition which, in the opinion of the investigator, would put the person at risk or seriously compromise the integrity of the study
Vitamin d Levels and Coronary Catheterization

decreased vitamin d levels are associated with increased inflammatory markers,and renin angiotensin levels.

decreased levels were also found to be connected to increased cardiovascular mortality.

we therefore hypothesise that in patients with pathological results of coronary catheterization we will find decreased levels of 25 hydroxy vitamin d.

we will examine patients undergoing elective coronary catheterization and compare two groups: those with normal results and those with pathological results.


Eligibility Criteria:
Inclusion Criteria:age

* \>18 years,
* no known ihd

Exclusion Criteria:

* renal failure ,
* medications including vitamin d, calcium ,phosphate
* hyper or hypoparathyroidism,
* abnormal calcium or phosphate values,
* known pathological coronary catheterization.
the Prevalence of Oral Manifestation in Patients With SARS-CoV2 Infection

The SARS-Cov2 virus was identified in china at the end of 2019 and spread worldwide causing a global pandemic. Current research showed that SARS-Cov2 virus invades human cells via the receptor angiotensin-converting enzyme 2 (ACE2) through scRNA-seq data analyses. The study identified the organs that are at risk and are vulnerable to SARS-CoV-2 infection. Therefore, cells with ACE2 receptor distribution may become host cells for the virus and cause inflammatory response in related organs and tissues, such as the tongue mucosa and salivary glands. These results suggest that oral mucosa could be a target of SARS-CoV-2 infection

The oral cavity is particularly susceptible to viral infection with several viruses such as herpes simplex virus, cytomegalovirus and Zika virus because of its structures, especially salivary glands and soft tissues . Moreover, oral mucosa can be affected by secondary pathological process of a bacterial or fungal nature due to viral immunosuppression. The oral cavity could be considered a "biological barometer" of both viral infection and viral immunosuppression advancement .

The SARS-Cov2 virus was identified in china at the end of 2019 and spread worldwide causing a global pandemic. Current research showed that SARS-Cov2 virus invades human cells via the receptor angiotensin-converting enzyme 2 (ACE2) through scRNA-seq data analyses. The study identified the organs that are at risk and are vulnerable to SARS-CoV-2 infection. Therefore, cells with ACE2 receptor distribution may become host cells for the virus and cause inflammatory response in related organs and tissues, such as the tongue mucosa and salivary glands. These results suggest that oral mucosa could be a target of SARS-CoV-2 infection .

Although many authors reported the presence of oral lesion associated with SARS-CoV2 infection, the prevalence of the oral manifestation and the range of oral manifestation are still unknown. Further studies are necessary to better understanding of the symptoms of the SARS-CoV2 virus in order to faster detection. A multidisciplinary team following the patients could be the key in treatment of the infection and faster recovery.

Eligibility Criteria:
Inclusion Criteria:

* A diagnosis of SARS-CoV2 with PCR.
* Age range from 18-60 years old
* Hospital admission not more than 10 days

Exclusion Criteria:

* Pregnancy or contraceptive pills
* Lactation
* Any auto-immune disease that could affect the oral mucosa
* On any neoplastic therapy.
* Uncontrolled diabetes.