cyrilzakka/clinical-trials huggingface dataset:
Effects of Augmented Reality on Humans

Nowadays, augmented reality (AR) has gained attention but little is known concerning its repercussion in individuals when considering some mental and physiological aspects. Therefore, the aim of this study was to investigate the effects of AR glasses on some cognitive and physiological functions in an attempt to determine its safety for workers.

Twelve volunteers were tested during two separate randomized sessions: one with AR glasses (ARGlass) and one in normal condition (Normal). Participants had two perform different tasks of a 90 minutes total duration. Before, during and after these tasks, two feet balance, one foot balance, precision balance, stroop and memory tests were performed. Also, heart rate and electromyographic activity of some muscles were recorded. Finally a survey was filled to determine, for example fatigue, pain or comfort.

Eligibility Criteria:
Inclusion Criteria:

* healthy
* BMI \< 27
* physically active
* informed consent written form

Exclusion Criteria:

* in-habitual fatigue
* taking drugs and alcohol more than twice a day
* potential psychomotor disease
* injury in the preceding 3 months
* no healthcare
CNGB1 and Allied Disorders

Mutations in the rod-expressed gene, cyclic nucleotide-gated channel beta subunit (CNGB1) and associated inborn errors in metabolism are causes of retinal disease that causes progressive loss of vision. Retinitis pigmentosa (RP) is a major cause of untreatable blindness associated with CNGB1 (CNGB1-RP). RP involves the death of photoreceptor cells that can be caused by mutations in a number of different genes. Treatment by gene therapy could prevent blindness in cases of inherited retinal dystrophies including RP. In the future RP due to mutations in CNGB1 may be treatable by gene therapy since this form of photoreceptor degeneration involves a slow loss of rod photoreceptor cells. This provides a wide window of opportunity for the identification of patients and initiation of treatment. Our efforts are directed toward developing gene therapy as a treatment. To this end, our objective is to better understand the disease process of CNGB1-RP and other allied inherited disorders so that we can develop clinical tests to measure the outcomes of treatment.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of CNGB1-associated RP by study physician, who are trained retinal specialists in the university clinic
* Must be able to commit to 4 follow-up study visits (3 years)
COVID-19 Vaccinations With a Sweepstakes

To reach herd immunity for COVID-19, experts estimate that 70% of the population will need to be vaccinated. However, vaccination rates have begun to slow down in the United States. The investigators will partner with Philadelphia to launch a COVID-19 vaccination sweepstakes, in which residents will be eligible to win if they have received at least one dose of the COVID-19 vaccine prior to a given drawing. Drawings will be held every two weeks; multiple prizes of various sizes will be awarded in each drawing. Half of the prizes in each size category in each drawing will be awarded to residents of a zip code that is randomly selected from a pre-defined list of under-vaccinated zip codes (this zip code will be announced at the start of each 2-week drawing period), the other half will be awarded to residents outside of that selected zip code. The investigators will analyze vaccination rates in Philadelphia as compared with neighboring regions before, during, and after the specified time period, as well as analyze vaccination rates in the three selected zip codes compared to the other zip codes that could have been targeted (the residual set of under-vaccinated zip codes) to determine the effectiveness of the sweepstakes at encouraging vaccinations.


Eligibility Criteria:
Inclusion Criteria:

* All 18+ residents of the City of Philadelphia will be eligible. Residents will be able to win the sweepstakes prizes if they can verify they received at least one dose of the COVID-19 vaccine before the date of the sweepstakes drawing in question.

Exclusion Criteria:

* None.
The Validity and Reliability of Brief Infant Sleep Questionnaire Revised (BISQ-R)

Brief Infant Sleep Questionnaire is a frequently used validated tool originally developed by Sadeh for evaluation of behavioral sleep problems in young children. It has been translated into Turkish and found reliable. The questionnaire has been revised and a norm referenced scoring system for the Brief Infant Sleep Questionnaire Revised (BISQ-R) was developed by Mindell and her team (Mindell JA, Gould RA, Tikotzy L, Leichman ES, Walters RM. Norm-referenced scoring system for the Brief Infant Sleep Questionnaire - Revised (BISQ-R). Sleep Med 2019; 63:106-114). We aimed to validate BISQ-R using exploratory and confirmatory factor analytical techniques, to provide evidence for its factor validity and reliability in a Turkish population.

Brief Infant Sleep Questionnaire is a frequently used validated tool originally developed by Sadeh for evaluation of behavioral sleep problems in young children. It has been translated into Turkish and found reliable. The questionnaire has been revised and a norm referenced scoring system for the Brief Infant Sleep Questionnaire Revised (BISQ-R) was developed by Mindell and her team (Mindell JA, Gould RA, Tikotzy L, Leichman ES, Walters RM. Norm-referenced scoring system for the Brief Infant Sleep Questionnaire - Revised (BISQ-R). Sleep Med 2019; 63:106-114). We aimed to validate BISQ-R using exploratory and confirmatory factor analytical techniques, to provide evidence for its factor validity and reliability in a Turkish population.

The BISQ-R consists of 33 questions with 19 questions for scoring. There are 3 subscales including infant sleep, parent perception and parent behavior. The total and each subscale score ranges from 0 to 100. Total score is the average of the 3 subscale scores. Higher scores indicate better sleep quality, more positive perception of infant sleep, and parental behaviors that promote healthy and independent sleep.

Independent Turkish to English, and back translations were completed, and reviewed by BISQ-R team for consistency, and identified problems were resolved. The study is designed as a prospective observational study with an anticipated sample size of 300 children. An online google survey will be developed on the google platform securing data collection by a confidential log in system which can be filled out from smartphones, tablet or computer. For a test-retest reliability evaluation, a retest will be conducted in 100 participants with a 3 weeks interval between the administrations using Cronbach's alpha internal consistency coefficients, item analysis and test-retest method. The project has received Institutional Review Board (IRB) from Marmara University School of Medicine (02.09.2022.1127). After the data collection is completed, an application and an agreement form will be filled out and sent to BISQ-R team for scoring.

Eligibility Criteria:
Inclusion Criteria:

* Term born, typically developing children aged between 3 to 36 months and their parents

Exclusion Criteria:

* Having chronic diseases
National Congenital Heart Disease Audit

The National Institute of Cardiovascular Outcomes Research (NICOR) collects data and produces analysis to enable hospitals and healthcare improvement bodies to monitor and improve the quality of care and outcomes of cardiovascular patients.

The Congenital Heart Disease audit collects data on all cardiac surgery and therapeutic cardiac catheterisations procedures used to treat patients with congenital and acquired heart disease.

For acquired heart disease, the audit covers all arrhythmias \& cardiomyopathies in patients less than 16 years old only. For congenital heart disease, the audit collects data on both children and adult patients. The audit covers all specialist centers in the UK and Republic of Ireland.

The project aims to improve the quality of care for children and adults with congenital heart disease by providing national comparative analysis of procedure specific activity and outcomes of cardiac surgery and therapeutic cardiac catheterisation procedures. The audit also provides quality indicators for the antenatal detection of major congenital heart disease.

The current dataset is available from here:

http://www.ucl.ac.uk/nicor/audits/congenital/datasets

The Congenital Heart Disease audit collects data on all cardiac surgery and therapeutic cardiac catheterisations procedures used to treat patients with congenital and acquired heart disease

Data collection:

Hospitals use Patient Administration Systems and manual data entry by cardiac database managers to submit data to NICOR.

Data are either assimilated locally using third party commercial software and imported as a .csv file, or entered directly onto the NICOR database.

Data quality:

NICOR provide tools that communicate possible errors to centres submitting data. A data submitting schedule has been agreed with the centres, data is submitted and a validation report is returned each quarter. Centres are responsible for updating errors in the records.

An import log highlights missing and invalid data as well as records that failed to import due to data quality or compatibility issues.

In addition, data is validated by on site visits with a NICOR representative.

Data linkage:

Data is annually linked with Office fot National Statistics (ONS) life status and Hospital Episodes Statistics (HES) admission data to verify case ascertainment and to track long term outcome measures.

Information governance:

NICOR has Section 251 approval and data protection registration. An organisation-wide standard operating procedure is in place for Information Security Incident Management. University College London has a robust information governance framework, to which NICOR adheres.

Eligibility Criteria:
Inclusion Criteria:

Patient, judged by multidisciplinary team meeting as unsuitable for the procedure

Exclusion Criteria:

Patient, judged by multidisciplinary team meeting, as unsuitable for the procedure
Study of MDX-1203 in Subjects With Advanced/Recurrent Clear Cell Renal Cell Carcinoma (ccRCC) or Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma (B-NHL)

The purpose of this study is to determine if MDX-1203 is safe for the treatment of renal cell carcinoma or non-hodgkin's lymphoma.

Multicenter, open-label, dose-escalation, multidose study of MDX-1203, a fully human monoclonal antibody drug conjugate targeting the CD70 transmembrane cell-surface protein which is highly expressed in ccRCC and B-NHL. MDX-1203 is composed of a human anti-CD70 monoclonal antibody covalently linked to a prodrug form of a cytotoxic deoxyribonucleic acid (DNA) minor-groove binding agent (MGBA).

The study will consist of 3 periods: Screening (up to 28 days), Treatment (up to 17 cycles or 2 years), and Follow-up (up to 6 months).

Eligibility Criteria:
Inclusion Criteria:

* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2
* Criteria specific to each tumor type:

  * For Clear cell renal cell carcinoma (ccRCC): advanced or recurrent disease. Must have failed at least 1 prior systemic therapy
  * For B-cell non-Hodgkin's lymphoma (B-NHL): Must have failed at least 1 prior systemic therapy
* Measurable disease criteria by tumor type:

  * For ccRCC: At least 1 unidimensional measurable lesion
  * For B-NHL: At least 1 bidimensionally measurable lesion
* Prior therapies for advanced/recurrent ccRCC or relapsed/refractory B-NHL or have become intolerant to a systemic therapy
* Provide archived or fresh tumor tissue for CD70 status. Subjects must be CD70+
* Provision of fresh tissue (pre-treatment and on-treatment) for exploratory analysis is mandatory for at least 5 and a maximum of 10 B-NHL subjects

Exclusion Criteria:

* Prior therapy with an anti-CD70 antibody
* History of severe hypersensitivity reactions to other monoclonal antibodies
* Active or untreated central nervous system lymphoma
* Active infection (viral, bacterial, or fungal)
* Evidence of bleeding diathesis or coagulopathy
* Active autoimmune disease requiring immunosuppressive therapy
* Known current drug or alcohol abuse
Patient Satisfaction and Sensory Attributes Allergic Rhinitis Nasal Spray

The study seeks to understand patients' satisfaction and importance of treatment attributes for Allergic Rhinitis nasal sprays from two brands (RYALTRIS® vs. DYMISTA®).

The study seeks to understand patients' satisfaction and importance of treatment attributes for Allergic Rhinitis nasal sprays from two brands (RYALTRIS® vs. DYMISTA®).

To directly compare patient satisfaction with 2 different Allergic Rhinitis nasal sprays, an observational, cross-sectional study design with 2 independent samples was chosen. Participants will complete an online survey involving a Best-Worst scaling (BWS) task to determine satisfaction and importance index for sensory attributes.

The suggested treatment attributes are informed by a range of previous studies, including those conducted by Meltzer et al 2005 and Price et al 2020, and methodology from CaPPRe's own work in developing indices for importance and satisfaction of treatment attributes using BWS.

Eligibility Criteria:
Inclusion Criteria:

Allergic Rhinitis patients (moderate-to-severe Seasonal Allergic Rhinitis or Perennial Allergic Rhinitis) with or without conjunctivitis who meet the following criteria will be offered the opportunity to participate in the study:

* Patients above 18 years old
* Fluent in English
* Patients initiated on RYALTRIS® or DYMISTA® nasal spray in the last 12 months and currently using treatment
* Willing and able to provide consent to participate

Exclusion Criteria:

* Have reported a loss of taste and/or smell related to COVID-19 (or other medical condition)
* Are employed by a pharmaceutical company (to avoid conflict of interest)
* Are employed by a vaccine company (to avoid conflict of interest)
* Do not have access to the internet (to ensure validity of the data)
* Are unable to read and understand English (to ensure validity of the data)
A Multi-Site Clinical Evaluation of the ARIES Group A Strep Assay in Symptomatic Patients

A multi-center evaluation to assess the diagnostic sensitivity and specificity of the ARIES Group A Strep Assay will be established through a method comparison using prospectively collected, de-identified, clinical samples collected during the enrollment period.


Eligibility Criteria:
Inclusion Criteria:

* Patient and/or patient's legal guardian is willing and able to give informed consent and/or assent for extra research sample.
* The subject's specimen is a throat swab in Liquid Amies based transport medium.
* The specimen is from an adult or pediatric, male or female subject who is either hospitalized, admitted to a hospital emergency department, visiting an outpatient clinical or resident of a long term care facility.
* The specimen is from a patient for whom a requisition has been made for Group A Strep testing
* The specimen is from a patient exhibiting clinical signs and symptoms of pharyngitis consistent with Group A Strep infection.
* The specimen was received in good condition (no leakage or drying of the specimen).
* The specimen volume is ≥ 850 µL.

Exclusion Criteria:

* The specimen is from a patient who did not provide informed consent/assent.
* The specimen is not a throat swab collected in Liquid Amies based transport medium.
* The specimen is from a patient who is undergoing antibiotic treatment.
* The specimen was not properly collected, transported, processed or stored according to the instructions provided by the Sponsor in Section 9 below.
* The specimen volume is \< 850 µL.
Bariatric Surgery and Sperm Quality

The purpose of this study is to evaluate the impact of a bariatric surgery (gastric banding, bypass, sleeve gastrectomy) on several parameters (quality of sperm and others biological parameters, lifestyle, quality of life) involved in fertility of obese adult men.

In order to assess how bariatric surgery may influence their fertility parameters, patients will attend to 3 visits :

First visit (inclusion, before surgery) :

* Signature of consent
* Patient interview (Collection of data on background, treatments, socio-demographic characteristics, social and familial environment, food consumption and habits, tobacco and alcohol use, physical activity, libido and quality of life (surveys))
* Clinical examination and anthropometric assessment (BMI, blood pressure, expired CO)
* Blood samples (Metabolic and nutritional plasmatic biomarkers ; Plasmatic oxidative stress biomarkers ; antioxidants micronutrients ; hormones of adiposity and inflammation ; sex hormones ; persistent contaminants)
* Sperm sample (sperm count-morphology ; DNA fragmentation ; CASA)

Bariatric surgery

Second visit (6 month follow-up)

* Report of adverse events if any
* Surveys
* Blood and sperm samples

Third visit (12 month follow-up)

* Report of adverse events if any
* Blood and sperm samples

Eligibility Criteria:
Inclusion Criteria:

* Obese men with BMI ≥ 40kg/m² or 35 kg/m² with associated co-morbidities
* Selected for bariatric surgery by multidisciplinary team
* From 18 to 50 years old included
* With a first medical consultation and its results
* With their written informed consent to participate in the study
* No problem for understanding verbal or written French
* An affiliation to social security

Exclusion Criteria:

* Not candidates for surgery
* With non idiopathic alteration of spermatogenesis
Measurement of Cardiac Output and Intravascular Volume Status in Children Using COstatus (SH)

Assessment and monitoring of cardiac function in the pediatric intensive care unit (PICU) is an integral part of hemodynamic monitoring of critically ill patients whether it is done directly or indirectly. Measurement of cardiac output (CO) can specifically guide therapies to support the cardiovascular system in critically ill children with multi organ dysfunction. Because of the side effects involved in measuring cardiac output directly, intensive monitoring of patients is currently limited to an integrated assessment of tissue perfusion, oxygen delivery and cellular health both at regional and global levels. Currently available methods of measuring CO have their limitations and complications, and are not used routinely for bedside monitoring. Therefore, the investigators propose to use a newly developed method, termed COstatus for the monitoring of CO in patients admitted to PICU.


Eligibility Criteria:
Inclusion Criteria:

1. Patients under 21 years
2. Presence of compensated or decompensated shock irrespective of etiology
3. Presence of an existing peripheral arterial and central venous catheters

Exclusion Criteria:

1. Patients allergic to heparin
Biomarkers in Clozapine-responding Schizophrenia

The outline of the current project is to establish a cohort of patients with treatment refractory schizophrenia eligible for clozapine, to identify clinical and biological characteristics of clozapine responding patients. Patients will be offered treatment with clozapine according to national clinical guidelines. Before clozapine is initiated, patients will be offered a thoroughly neurobiological examination, and re-examination will be carried out after 12 weeks of treatment. The primary focus of the examinations will be immunological markers and autoantibodies in the blood and cerebrospinal fluid, permeability of the blood-brain barrier and magnetic resonance imaging of structural, neurochemical and functional brain changes.

Patients will be examined before and after 12 weeks of treatment with clozapine

Examinations at baseline and follow up will be:

* Clinical ratings
* Blood inflammatory markers
* Inflammatory markers in cerebro spinal fluid
* MRI : examination of grey \& white matter, glutamate and GABA in Anterior Cingulate cortex and glutamate in thalamus,
* selected cognitive measures

Eligibility Criteria:
Inclusion Criteria:

* According to ICD-10 fulfill diagnostic criteria for schizophrenia (F20.x), chronical paranoid psychoses (F22), Schizoaffective psychoses (F25) or other non-organic psychoses (F28/F29);
* Age 18-65 years;
* Legally competent;
* Stabil antipsychotic treatment during last month
* Being treatment refractory according to TRIPP-guidelines (Howes et al. 2017) defined as having tried at least two antipsychotic drugs in sufficient dosage (≥600 mg chlorpromazine equivalent) for a sufficient time (≥ 6 weeks) without sufficient symptom improvement (still a moderate level of positive symptoms).
* Recreational use of substances is allowed as long as it does not interfere with compliance
* Fertile females must use safe contraception (spiral or any hormonal contraception).

Exclusion Criteria:

* Involuntarily psychiatric admittance during the study
* Substance abuse that interfere with compliance
* Pregnancy (will be verified by urine-HCG-test in fertile females)
* Toxic or idiosyncratic agranulocytosis in the past
* Reduced bone marrow function according to blood samples
* According to information from patient and available files, noUncontrolled

  * Current uncontrolled epilepsy
  * Current circulatory collapse and / or CNS depression for any cause
  * Current severe kidney, heart or liver disease
  * Current paralytic ileus
French-Canadian Version of the Wheelchair Skills Program (WSP)

The purpose of this project is to develop French Canadian versions of the Wheelchair Skills Program (WSP). Translating a measurement instrument in the field of biomedical sciences requires not only the language to be taken into account but also the cultural context. We will determine the measurement properties of the WST-F and complete the randomized controlled trial on the efficacy of the WSTP-F.


Eligibility Criteria:
Inclusion Criteria:

* eighteen (18) or older;
* use a manual wheelchair at least four (4) hours per day;
* in the rehabilitation process (including training in manual wheelchair use);
* have enough ability to develop skills included in the wheelchair skills training program;
* are willing to take part in the study;
* French-speaking individual capable of understanding enough of the English language to sign this form after carefully reading it
* competent to give informed consent or have a proxy with power of attorney;
* have the verbal endorsement of the clinical therapist (if any) to participate;
* have the permission of the attending physician or occupational therapist to participate;
* are alert and cooperative.

Exclusion Criteria:

* have an unstable medical condition (e.g. angina, seizures), as indicated by the attending physician, hospital or rehabilitation centre staff, enhanced registered nurse or self-report;
* have an emotional or psychiatric problem of a type or extent that might make participation unpleasant, as indicated by the attending physician, hospital or rehabilitation centre staff, enhanced registered nurse or self-report.