cyrilzakka/clinical-trials huggingface dataset:
Using Serious Game Technology to Improve Sensitivity to Eye Gaze in Autism

The investigators hypothesize that this serious game (designed to provide a learning environment that maximizes opportunities for adolescents with autism to discover the functional utility of eye gaze) will improve sensitivity to eye gaze cues, specifically to identify gazed-at objects, and will also lead to increased social attention to faces in adolescents with autism. The investigators will test this hypothesis in a small-scale exploratory randomized control trial that will include both behavioral and eye tracking outcome measures.


Eligibility Criteria:
Inclusion criteria:

1. parent/caregiver of an adolescent with a diagnosis of ASD,
2. parent/caregiver and adolescent with ASD both native English speakers,
3. adolescent with ASD aged between 10-18 years at enrollment,
4. adolescent has normal vision and hearing with correction as indicated by parent report,
5. adolescent is able to use a computer for the purposes of game play,
6. adolescent scores \> 80% correct (i.e., 0.5 SD less than M of TD adolescents) on online eye gaze screening task,
7. ASD diagnosis of adolescent confirmed in lab via the Autism Diagnostic Observation Schedule,
8. Full Scale IQ of adolescent determined to be between 70-130 on the Kaufman Brief Intelligence Test,
9. reading ability of adolescent determined to be at least a second grade level as assessed by the Oral and Written Language Scales,
10. adolescent is capable of cooperating with testing,
11. parent/caregiver and adolescent both consent/assent to participate in the research.

Exclusion Criteria

1. adolescent has had seizures within the previous two years,
2. family lacks stable home internet,
3. parent or adolescent refuses to consent/assent to take part in the research,
4. adolescent is 18 and has a legal guardian, prohibiting him/her from legally consenting, or
5. adolescent is 18 and cannot understand the consent (i.e., fails consent quiz).
Tezepelumab COPD Exacerbation Study

A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase 2a Study to Explore the Efficacy and Safety of Tezepelumab in Adults with Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD)

This is a Phase 2a, multicenter, randomized, double-blind, placebo-controlled, parallel group study to evaluate the safety and efficacy of tezepelumab in adults with moderate to very severe chronic obstructive pulmonary disease (COPD) receiving triple inhaled maintenance therapy, and having had 2 or more documented COPD exacerbations in the 12 months prior to Visit 1. Approximately, 338 subjects will be randomized globally. Subjects will be stratified by region and prior number of exacerbations (2 vs. 3 or more). Subjects will receive tezepelumab, or placebo, administered via subcutaneous injection at the study site, over a 52 week treatment period. The study also includes a post-treatment follow-up period of 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

1. History of moderate to very severe physician-diagnosed COPD for at least 12 months prior to enrolment with a post-bronchodilator FEV1/FVC\<0.70 and a post-bronchodilator FEV1 ≥20% and ≤80% of predicted normal value.
2. History of at least 2 documented moderate to severe COPD exacerbations within 2 to 52 weeks prior to enrollment.
3. CAT score of ≥15 at enrollment and on day of randomization.
4. Documented treatment with triple therapy for COPD (medium or high dose ICS/LABA/LAMA) throughout the year prior to enrollment. The dose of ICS should be stable for 3 months prior to enrollment.

Exclusion Criteria:

1. Clinically important pulmonary disease other than COPD, as judged by the Investigator (including current or historic asthma diagnosis).
2. Any disorder, including, but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious (including risk factors for pneumonia), endocrine, metabolic, hematological, psychiatric, or major physical impairment that is not stable.
3. Major surgery within 8 weeks before enrollment.
4. History of clinically significant infection requiring antibiotics or antiviral medication within 14 days before enrollment.
5. Pregnant or breastfeeding.
6. The chest/lungs with pathology that precludes the patient's ability to complete the study
7. The patient has active COVID 19 infection during screening period.
Patient Engagement With Digital Health Tools in Rheumatology

The purpose of this study is to evaluate the patient engagement with digital tools for diagnosis and monitoring of disease in rheumatology services

The investigators plan to undertake a mixed methods study to investigate a digital algorithm to potentially inform triage of new patient referral to rheumatology services, as well as to inform follow up review schedules. Current practice at out hospital is to ask all newly referred patients to complete a pre-appointment digital questionnaire prior to their clinic visit. Patients who need follow up are then routinely invited to continue to return interval questionnaires related to their symptoms between clinic visits.

The investigators believe that the questionnaire responses could enable appropriate (and safe) allocation to a particular clinic (e.g. urgent early arthritis clinic or general rheumatology clinic for a new referral), or define an appropriate clinic follow up interval for a repeat visit for patients with a rheumatic disease.

Our study aims to evaluate these questionnaires using data collected from routine clinical practice, as well a series of semi-structured interviews with service users.

Eligibility Criteria:
Inclusion Criteria: quantitative phase:

* Aged 18 years and above
* Able to complete the questionnaire in English

  1. New patient pre-appointment questionnaires
* Referred as a new patient to the rheumatology outpatient department at Guys and St Thomas' Trust between 01/01/2019 to 01/10/2023 and sent a digital pre-appointment questionnaire
* Electronic patient notes recorded between 01/01/2019 to 01/10/2024

  2. Follow up patients PROM questionnaires
* Patients under followup of the rheumatology department at Guys and St Thomas' Trust with a diagnosis of rheumatoid arthritis, psoriatic arthritis or axial spondyloarthropathy who have been added to the remote monitoring program between 01/01/2019 to 01/10/2023
* Electronic patient notes recorded between 01/01/2019 to 01/10/2024

Inclusion criteria: qualitative phase:

* Aged 18 years and above

  1. New patient pre-appointment questionnaires
* Referred as a new patient to the rheumatology outpatient department at Guys and St Thomas' Trust between 01/01/2019 to 01/10/2023 and sent a digital pre-appointment questionnaire
* Able to communicate in English or any language offered for audio interpreting by the LanguageLine service

  2. Follow up patients PROM questionnaires
* Patients under followup of the rheumatology department at Guys and St Thomas' Trust with a diagnosis of rheumatoid arthritis, psoriatic arthritis or axial spondyloarthropathy who have been added to the remote monitoring program between 01/01/2019 to 01/10/2023
* Able to communicate in English or any language offered for audio interpreting by the LanguageLine service

Exclusion Criteria: quantitative phase:

* Under 18 years of age
* Unable to complete study questionnaires

Exclusion criteria: qualitative phase:

* Under 18 years of age
* Patients lacking the capacity to consent for themselves for the semi-structured interview
Feasibility Study of Sleep Endoscopy Under Hypnosis in a Sleep Center

It is proposed to induce in a obstructive sleep apnea syndrome patient, a hypnotic trance leading to intense muscle relaxation, capable of reproducing in the upper airways (VAS) the muscle relaxation observed in sleep, at the origin of obstructive apnea and snoring. The collapsibility type obtained, classified according to Kezirian, will allow specific management by OAM in the event of predominant anteroposterior stenosis. There are no risks fort the patient. The Drug Induce Sleep endoscopy (DISE) is a fibroscopy of upper aerodigestive tract.


Eligibility Criteria:
Inclusion Criteria:

* Patient, women or men over 18 years old
* Moderate obstructive sleep apnea syndrome (Hypopnea apnea index between 15 and 30) without any serious sign
* Simple Ronchopathy
* Indication of video-fibroscopy of upper airways
* Affiliated subject or beneficiary of a social security scheme
* Patient having signed the free and informed consent

Exclusion Criteria:

* Psychiatric disorders that can be decompensated by hypnosis (bipolarity, schizophrenia, ...)
* Smoking less than 10 cigarettes per day
* Alcoholism, chronic or serious disabling pathology
* Medical history of cancer of upper airways, radiotherapy
* Pregnancy
* Recent supper airway infection, rhinosinusitis
* Active allergy
* Non-obstructive sleep apnea syndrome
* severe non-obstructive sleep apnea syndrome (Hypopnea apnea index\> 30)
* Dental contraindication to mandibular advancement device
* Intolerance or allergy to local anesthesia with Xylocaine spray 5% known
* Refusal to participate in the study
* Protected patients: adults under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision
* Pregnant, breastfeeding or parturient woman
* Hospitalized without consent
DNA Repair and Genetic Susceptibility to Lung Cancer

The purpose of this study is to help us better understand the cellular changes that may lead to the development of lung cancer. We want to compare people with a second primary lung cancer with those who have only a first primary lung cancer. We hope to use the information obtained in this study as the basis for future studies and will not regard the results from this study as final.

We will analyze your blood cells and DNA to measure the changes in several genes that we believe may be involved in lung cancer. We also want to evaluate the capacity for your DNA to repair itself.


Eligibility Criteria:
Inclusion Criteria:

* Cases will be eligible for inclusion if:
* They have been diagnosed with a second primary lung cancer, and
* They speak English or a language for which we have a translated consent form, and
* They understand and agree to sign informed consent, and
* They agree to give us a blood sample, and
* They agree to give us a tissue sample when part of normal clinical procedures, and
* They agree to complete the study questionnaires, and
* They agree to have their pathology information reviewed. This could include biopsy specimens.

Controls will be eligible for inclusion if

* They have been diagnosed with a first primary lung cancer, and
* They speak English or a language for which we have a translated consent form, and
* They understand and agree to sign informed consent, and
* They agree to give us a blood sample, and
* They agree to give us a tissue sample when part of normal clinical procedures, and
* They agree to complete the study questionnaires,
* They agree to have their pathology information reviewed. This will could include biopsy specimens.

Exclusion Criteria:

* Subjects who do not meet the inclusion criteria as either cases or controls will not be eligible for this study.
* Control subjects who have a history of another cancer, other than nonmelanoma skin cancer or a first primary lung cancer, will not be eligible for this study.
* Control subjects who otherwise meet the eligibility requirements above but who have had chemotherapy and/or are currently being treated with chemotherapy will be excluded from the functional assay, but not from the genotyping.
Oral and Intravenous Tranexamic Acid in Lumbar Spine Surgery

The purpose of this project is to compare the effectiveness of two different but well accepted routes of administration of tranexamic acid in order to reduce blood loss and need for transfusion in patients undergoing lumbar spine surgery. Specifically, this study seeks to identify if intravenous tranexamic acid is superior to oral tranexamic acid in reducing blood loss and need for transfusion.

Spine surgery is associated with large amount of perioperative blood loss. Factors influencing blood loss include surgical technique, operative time, number of vertebral levels arthrodesed, and others. Significant blood loss is associated with complications such as hypotension, end organ damage, or coagulopathy. Blood transfusions can increase risks of infection, blood incompatibility, and allergic reactions. Due to the significant risks and complications associated with blood loss and allogenic transfusions, efforts to identify safe and effective ways of lowering blood loss during spine surgery are crucial. Many methods have been utilized to reduce allogenic blood transfusions, such as autologous blood predonation, antifibrinolytic drugs, acute normovolemic hemodilution, intraoperative blood salvage, and others. Furthermore, the administration of antifibrinolytics, such as tranexamic acid (TXA) and epsilon-aminocaproic acid (EACA), has been shown to reduce bleeding in cardiac, gynecological, urologic and total joint replacement surgeries. There have been many published studies investigating various antifibrinolytic agents such as TXA, EACA, and aprotinin. While aprotinin was shown to increase mortality rate in patients following cardiac surgery, TXA and EACA have not been shown to cause any substantial morbidity or to increase rate of thromboembolic events. Although IV TXA has been shown to be effective in reducing blood loss and transfusions in patients undergoing spine surgery, no studies in the literature have investigated the efficacy of PO TXA in decreasing blood loss and transfusions. The investigators believe that PO TXA will be just as efficacious and more cost-effective in reducing blood loss and transfusion needs in patients undergoing lumbar spine surgery.

The ultimate goal is identifying the most cost-effective protocol to decrease blood loss and need for transfusion. If oral TXA is found to be as efficacious as IV TXA in reducing blood loss and need for transfusion, significant cost savings can be achieved for the patient and the health care system in general.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients over age 18 and scheduled for open lumbar spine surgery (primary or revision)
* Must be able to swallow tablets

Exclusion Criteria

* Known allergy to TXA
* History of renal failure or kidney transplant
* History of arterial thromboembolic event (eg. myocardial infarction, stroke) within the past year
* Placement of an arterial stent within the past year
* History of blood clots (DVT, PE) within the past year
* Refusal to receive blood products
Mobilization With Movement vs. Neural Mobilization on Nerve Root Function in Patients With Cervical Radiculopathy

This study will be conducted to compare the effect of sustained natural apophyseal glides (SNAGS) versus neural mobilization on clinical outcomes such as 1- nerve root function in the form of: (A) peak to peak amplitude; (B) latency; (C) F wave. 2- pain pressure threshold (PPT) and 3- Neck disability index (NDI) in patients with cervical disc (C5-C6 and/or C6-C7) herniation.

Seventy two patients from both gender with cervical disc (C 5-C 6 and/or C 6- C7) herniation with both sensory and motor nerve affections will be recruited for this study following referral from an experienced neurologist and confirmed diagnosis by MRI. The patients' age will range between 20-50 years, body mass index (BMI) from 18 to 25 kg/cm2.

The patients will be assigned randomly by permuted block to three equal groups; group (A) will receive SNAGS in addition to traditional therapy, group (B) will receive neural mobilization in addition to traditional therapy and group (C) will receive traditional therapy.

peak to peak amplitude, nerve latency and F wave will be measured by electromyography, , pressure pain threshold will be measured by commander algometer. Neck disability will be measured by Arabic neck disability index.


Eligibility Criteria:
Inclusion Criteria:

1. seventy patients with cervical disc (C 5-C 6 and/or C 6- C7) herniation with both sensory and motor nerve affections, referred from neurologist and confirmed diagnosis by MRI
2. Both sexes.
3. Age between 20-50 years.
4. Patients with neck pain radiating down to the arm.
5. Patients with positive findings for spurling test, Upper Limb Tension Test One (ULTTO), cervical distraction test and cervical rotation test towards the symptomatic side \<60.
6. BMI from 18 to 25 kg/cm2
7. Existed active trigger points within middle trapezius and/ or cervical region.
8. Positive Pittsburgh sleep quality index' value \>10, means moderate and/ or sever difficulty.

Exclusion Criteria:

1. Patients experiencing primary shoulder or upper extremity problem of local origin
2. cardiovascular disorders and respiratory disorders,
3. pathological conditions involving cervical spine like vertebro basilar insufficiency and canal stenosis
4. osteophytes in cervical vertebrae
5. Patients who were undergoing treatment for neck pain with other means of physiotherapy at the time of the study
6. Cervical fractures, spinal surgery or other spinal pathologies (i.e. ankylosing spondylitis, spondylolisthesis)
7. Peripheral nerve lesions like neurotmesis and axonotmesis.
A Study of MK0594 in Patients With Alcohol Dependence (0594-020)

A study in patients with alcohol dependence to see if MK0594 is safe and effective in maintaining absence of heavy drinking over a 12-week treatment period.


Eligibility Criteria:
Inclusion Criteria:

* Patient has Diagnostic and Statistical Manual of Mental Disorders, fourth edition, text revision diagnosis of alcohol dependence and alcohol addiction
* Patient has two heavy drinking days in the last 30 days
* Patient has 3 days of abstinence from alcohol right before taking study medication
* Patient has lived in the same residence for the last 2 months

Exclusion Criteria:

* If female, patient is pregnant or breastfeeding
* Patient anticipated inpatient alcohol treatment
* Patient has a history of suicide attempt in the last year
* Patient has schizophrenia or bipolar disorder
* Patient has a history of multiple or serious allergies
* Patient has participated in a clinical trial in the last 30 days
Survival of Endocrowns Made From Different Ceramics

Restoration of endodontically treated teeth requires a means to protect the cusps from the wedging forces of occlusion. When there is extensive loss of tooth structure, cuspal coverage is warranted. Usually this is in the form of indirect restoration. Traditionally, full coverage crowns have been used which would require further removal of sound tooth structure. Recently, adhesive alternatives have been introduced which allow for conservation of tooth structure.

Different materials can be used for this purpose. The evidence on the long-term survival of these materials is scarce. This study aims to investigate the short and medium-long term survival rate of these prostheses.


Eligibility Criteria:
Inclusion Criteria:

* Root canal treated molars with significant loss of tooth structure
* Supra-gingival margins
* Teeth scheduled for cuspal-covering indirect restorations

Exclusion Criteria:

* Teeth with extensive cracks or fractures
* Teeth with deep subgingival margins
* Non-functional teeth (no opposing dentition)
* Teeth with advanced periodontitis
Clinical Trial to Evaluate the Safety and Tolerability of Lagricel® Ofteno Multi-dose Ophthalmic Solution

Study design: Phase I clinical trial, single-center, controlled, parallel group, open, randomized.

Number of subjects: n = 34 evaluable subjects, 17 evaluable subjects per group (both eyes).

Estimated duration of the study: 5 months

Therapeutic indication: Eye lubricant Use: Dry Eye

Objective:To evaluate the safety and tolerability of Lagricel® Ofteno multidose manufactured by Laboratorios Sophia on the ocular surface of clinically healthy subjects.

Hypothesis:

H0 = Lagricel® Ofteno multidose ophthalmic solution has a safety and tolerability profile similar to Lagricel® Ofteno single dose in healthy subjects.

H1 = Lagricel® Ofteno multidose ophthalmic solution has a different safety and tolerability profile than Lagricel® Ofteno single dose in healthy subjects.

Main inclusion criteria: Clinically healthy subjects


Eligibility Criteria:
Inclusion Criteria:

* To be clinically healthy
* To have the ability to voluntarily grant your signed informed consent
* To have the willingness to comply with scheduled visits treatment plan and other study procedures
* Women in reproductive age should ensure the continuation (initiated ≥ 30 days prior to the signing of the informed consent) to use a hormonal contraceptive method or intrauterine device during the study period.
* To have a better corrected visual acuity of 20/30 or better in both eyes.
* To have vital signs in normal parameters.
* To have an intraocular pressure between ≥10 and ≤ 21 mmHg.

Exclusion Criteria:

* To be user of ophthalmic topical products of any kind.
* To be user of medicines, or herbal products, by any other route of administration.
* In the case of women: being pregnant, breastfeeding or planning to get pregnant in the study period.
* Having participated in clinical research studies 90 days prior to inclusion in this study.
* Having previously participated in this same study.
* To be a user of contact lenses and can not suspend their use during the study.
* Having initiated the use of hormonal contraceptives or intrauterine devices, 30 days prior to inclusion in the present study.
* To have a history of any chronic degenerative disease.
* Having inflammatory or infectious disease, active at the time of admission to the study.
* Having injuries or unresolved injuries at the time of admission to the study.
* Having a history of any type of eye surgery.
* Having undergone surgical procedures, not ophthalmological, in the last 3 months.
* To be or to have an immediate family member (for example: spouse, parent / legal guardian, brother or child) who is part of the research site staff or the sponsor who participates directly in this study.