cyrilzakka/clinical-trials huggingface dataset:
Study of Using the Hyper-CL™ Lens (Hyper Osmotic Contact Lens) in Subjects Suffering From Corneal Edema

The Hyper-CL™ lenses are indicated for therapeutic use as a bandage to protect the corneal surface and to relieve corneal pain in the treatment of acute or chronic ocular pathologies, such as bullous keratopathy, corneal erosions, entropion, corneal edema, and corneal dystrophies as well as post-surgical conditions resulting from cataract extraction and corneal surgery. The lenses may be prescribed for daily wear with removal for cleaning and disinfection (chemical, not heat) prior to reinsertion, as recommended by the eye care professional.

In addition Hyper-CL™ contact lenses can also provide optical correction during healing if required.

This study is a prospective, randomized crossover study. The primary aim of this study is to assess the safety and effectiveness of using the Hyper-CL™ lens +salt solution (5% NaCl) as compared with using regular contact lens + salt solution (5% NaCl) in subjects suffering from corneal edema. Safety will be assessed by evaluating the rate of adverse events and adverse device effects occurred throughout the study period. Effectiveness will be assessed by measuring changes in corneal thickness and visual acuity.

Subjects with corneal edema will be the study population. Only subjects who have signed the informed consent form and meet all the eligibility criteria listed below will be qualified for enrollment. The study will encompass a total of up to 80 subjects who will complete the Protocol follow-up schedule.

Each subject will be treated with:

Treatment A: Hyper-CL™ lens + salt solution + antibiotics drops (7 days) Treatment B: Regular soft contact lens +salt solution+ antibiotics drops (7 days) One week (7 days) of washout without any treatment will be between treatments. Subject will be equally allocated to one of the following 2 crossover regimen based on a randomization scheme with blocks stratified by center: A-B; B-A

Eligibility Criteria:
Inclusion Criteria:

1. Subject is over 18 years old
2. Subject with corneal edema in the visual access
3. Subject with visual acuity of 6/20 or worse (equivalent ETDRS) clinically explained by corneal edema
4. Subject understands the study requirements and the treatment procedures and provides written Informed Consent before any study-specific tests or procedures are performed.

Exclusion Criteria:

1. Subject with active Herpes keratitis
2. Subject with scarred cornea
3. Subject who is suffering from erosions and/or infections of the cornea (red eye)
4. Subject with glaucoma shunts (e.g. Ahmed valve) and or bleb
5. Subject who require chronic administration of any topical ophthalmic beside lubrication eye drops and steroids or anti glaucoma drags
6. Subject who is currently participating or have participated in an investigational study, other than this study, within the past 60 days
A Study to Evaluate FK778 in Kidney Transplant Patients

A dose finding study to evaluate the safety and effectiveness of FK778 in kidney transplant patients


Eligibility Criteria:
Inclusion Criteria:

* Patient has end stage kidney disease or needs retransplantation (loss of graft for non-immunological reasons).
* Patient has been fully informed.

Exclusion Criteria:

* Patient has an immunological high risk and/or having a previous graft survival shorter than 1 year due to immunological reasons.
* Patient has significant liver disease.
* Cold ischemia time of the donor kidney \>28 hours.
* Patient having uncontrolled concomitant infections and/or severe diarrhoea, vomiting, active upper gastro-intestinal tract malabsorption or active peptic ulcer.
* Patient has previously received or is receiving an organ transplant other than kidney.
Virtual Reality Intervention for Fear of Heights

Exposure-based cognitive behavior therapy is an efficacious treatment for acrophobia (fear of heights) and has been delivered effectively in a virtual reality (VR) environment. The present study is designed to evaluate the effects of liked, non-lyrical background music on the efficacy of a brief VR exposure intervention.

The goal of this clinical trial is to compare acrophobia (fear of heights) outcomes for VR exposure therapy in college students with elevated acrophobia when listening to music during exposure versus no music. The overarching aim of the current study is to determine how liked, non-lyrical background music will influence acrophobia outcomes after a brief exposure therapy session in VR.

The study involves three phases: (1) initial screening, (2) in-person assessment and a brief exposure intervention for a subset of participants with elevated acrophobia, and (3) a one-week follow-up assessment conducted online. Students who choose to participate and screen high on an acrophobia scale will be assigned to an experimental or control condition prior to undergoing VR based exposure therapy. Acrophobia outcomes are measured immediately post-intervention and one week later.

Researchers will compare participants in the music condition to participants in the non-music condition to see if acrophobia outcomes differ.

Eligibility Criteria:
Inclusion Criteria:

* Self-report of 18 years of age or older
* Current student at Boston University
* Ability to read English to provide informed consent
* Familiarity with a computer keyboard and mouse or a touch screen device (e.g. phone, tablet)
* For Phase 2: Acrophobia score of ≥ 45.45 on the Acrophobia Questionnaire (AQ) Anxiety Subscale

Exclusion Criteria:

* Previous participation (i.e. no participant may take the survey more than once).
Safety and Tolerability of Liraglutide in Subjects With Impaired Kidney Function and in Subjects With Normal Kidney Function

This trial is conducted in Oceania. The aim of this trial is to assess whether dose adjustment is required for patients with renal impairment by investigating the pharmacokinetics of liraglutide in subjects with various degrees of renal impairment.


Eligibility Criteria:
Inclusion Criteria:

* Subjects meeting the pre-defined GFR (glomerular filtration rate) criteria (estimated by the Cockcroft and Gault formula) for any of the renal function groups
* Body Mass Index (BMI) maximum 40 kg/m\^2

Exclusion Criteria:

* Known or suspected allergy to trial product(s) or related products
* Renal transplanted patients
* Haemodialysis patients
* Cardiac problems
* Uncontrolled treated/untreated hypertension
* History of alcoholism or drug abuse during the last 12 months
* Smoking of more than 10 cigarettes per day, or the equivalent for other tobacco products
* Habitual excessive consumption of methylxanthine-containing beverages and foods (coffee, tea, soft drinks such as cola, chocolate) as judged by the investigator
* Excessive consumption of food deviating from a normal diet as judged by the Investigator
Intracardiac Echocardiography Guided Watchman Device Implant

This study is to look at the success of Intracardiac Echocardiography (ICE) in the Watchman procedure. Currently the process is to use a Transesophageal Echocardiography (TEE) to place the Watchman in patients. This study is aiming to show how the ICE is just as effective in placing the device correctly and effectively.

Left atrial appendage occlusion is approved as an indicated therapy for patients with non valvular atrial fibrillation, high risk of stroke and an appropriate rationale for avoidance of long term use of oral anticoagulants.

Concurrent procedural TEE is an integral part of the procedure. It is used to guide trans-septal puncture, device sizing and assessment of final adequacy of device implant.

TEE requires the participation and guidance of a cardiac imager and because the TEE probe is in place for a relatively long duration the procedure, the procedure is most commonly performed under general anesthesia. Furthermore TEE can be associated with risk of injury to the oropharynx and esophagus. Our ongoing clinical experience and known literature suggest that TEE may not be necessary for the overall success of the procedure. The objective of the study is to investigate a new work flow that may ultimately demonstrate that intra-procedural TEE may not be necessary, obviating the need for additional personnel, general anesthesia and decreasing overall risk. ICE has been widely used to aid trans-septal puncture and visualize left atrial anatomy. Smaller studies and case series have reported the use of ICE as an alternative to TEE in guiding Watchman device implant. This has not been compared systematically with TEE in a large patient sample.

Eligibility Criteria:
Inclusion Criteria:

* All patients who meet guideline established criteria for commercially available Watchman device implant and not enrolled in an active clinical trial

Exclusion Criteria:

* Patients in whom a procedural TEE cannot be performed and an ICE only implant is needed.
* Patients receiving a concomitant ablation procedure
* Patients with prior incomplete surgical or percutaneous left atrial appendage ligation/exclusion procedures
* Patients in whom the delivery of trans-septal equipment is anticipated to be difficult (e.g. patent foramen ovale (PFO) or atrial septal defect (ASD) closure devices in place).
Improving Integration of Mentally Burdened Young Adults in the Labour Market

Young adults who do not successfully transition from compulsory education to upper secondary level are at increased risk of developing mental illness, as compared with their working peers. The causality is unclear: they are either unable to find a job due to a pre-existing mental illness, or their failure in finding a job has contributed to the mental illness.

The Zurich University of Applied Sciences has developed an innovative intervention that includes psychotherapeutic support in a work integration programme. Recognising and treating mental illness early increases the chances of a successful transition to the labour market.

Unemployed young people with severe psychological impairments often find no training or workplace, despite the support of various existing services. Many of these young people suffer from a mental illness, but they are often neither diagnosed nor treated. In Switzerland, this is reflected in the increasing number of young people who receive a disability pension. To make matters worse, young people often do not use the necessary psychotherapeutic treatment. An explanation for this may be the fear of being stigmatized or the lack of insight that help is needed al all. A group of researchers has analyzed the dossiers of 400 young people who were given a disability pension 2010 and 2013 due to mental problems. They have found that the consultation often took place before the 23rd year of age and in 84% of the cases whole disability pensions were given. In the analysed cases only 14% had completed vocational training. The authors propose various measures, including prioritizing the completion of a professional apprenticeship, a systematic interdisciplinary assessment, a joint, longer-lasting integration management, as well as early detection and intervention in psychological disorders in school and vocational training. Our intervention meets these requirements. Together with lifetime health, a provider work working integrations programs, we have developed a low-threshold psychotherapeutic offer in addition to the existing work integration program. With this intervention we hope to reach the following goals. First: Facilitate the transition into a professional apprenticeship by increasing work ability and other variables. Secondly, the integration and cooperation of a psychotherapist in the work integration program allows for a systematic interdisciplinary assessment; third, the support of a psychotherapist offers a joint, longer-lasting integration management.

Eligibility Criteria:
Inclusion Criteria:

* Age 16 to 25
* Participation in work integration programme "Lifetimehealth"

Exclusion Criteria:

* Insufficient knowledge of German
* Participant is under guardianship which doesn't allow legal capacity to act
Intraoral Measurement of Pressure in Preterm Infants

The aim of the study is to show pressure curves in the nasopharynx in non-invasively ventilated and spontaneously breathing premature and newborn babies

The aim of the investigation is to show the pressure curves in the nasopharynx in non-invasively ventilated and spontaneously breathing premature and newborn babies, with a number large enough for an analysis. For this purpose, the pressure in the nasopharynx of these children is to be measured using a suction catheter, as is usually used to suction off mucus and saliva, and the measured values are to be evaluated with software. This method is a tried and tested method in adults for measuring the pressure conditions in the nasopharynx, which was developed and used by Mr. Olthoff. A possible later clinical application in premature and newborn infants ranges from the measurement of breathing and ventilation to manual control of respiratory support depending on the measured value to automatic triggering and control of a ventilator in the sense of nSIPPV ventilation (non-invasive synchronized intermittent positive pressure ventilation )

Eligibility Criteria:
Inclusion Criteria:

newborns, non-invasive ventilation

Exclusion Criteria:

* Bad clinical condition of the patient (e.g. sepsis)
* Bleeding tendency
* Anatomical peculiarities that make it difficult to insert the suction catheter through the nose (e.g. choanal atresia)
* Lack of acceptance of the probe by the child
* Proven infection / colonization of the child by a multi-resistant germ (MRGN 2-4, MRSA) or with noro- / adenoviruses
* Missing / withdrawn consent by the legal guardians
Evaluation of Postoperative Pain in Children

Postoperative pain is a common symptom of a flare up after root canal treatments (RCTs). Insufficient instrumentation, extrusion of irrigation solutions and debris and existence of a periapical lesion are the factors affecting postoperative pain after root canal treatments. Aim of this study is to evaluate the postoperative pain and instrumentation time of single-file reciprocating system and multiple-file Ni-Ti rotary system in children ages between 9-12. Study was conducted on fifty first permanent mandibular molars with the diagnosis of irreversible pulpitis. Patients were randomly separated into two groups and RCTs were completed with either Reciproc Blue or Protaper Next file systems. Instrumentation time for each system was noted and patients were given a pain scale which included visual analog scale for 6, 24, 48 and 72 hours after treatment. Postoperative pain scores and instrumentation times were analyzed statistically with chi square test and student t test. There was no statistically significant difference in postoperative pain between Reciproc Blue and Protaper Next systems at all time intervals. Instrumentation time was significantly shorter in the Reciproc Blue group in comparison with the Protaper Next group. In conclusion, shorter treatment time of single-file reciprocating systems may be more patient friendly and comfortable than multiple-file rotary systems in RCTs among children.


Eligibility Criteria:
Inclusion Criteria:

* Patients with first permanent mandibular molar teeth which had been diagnosed with symptomatic irreversible pulpitis with no periapical pathology or abscess were included in the study.

Exclusion Criteria:

* Patients who were on antibiotics or analgesics preoperatively were not included in the study.
Validation of Algometry for Use in the Human Foot

The primary aim is to examine whether there is a consistent range of pressure threshold values for the asymptomatic foot.Previous studies established the inter/intra-clinician reliability of pressure threshold measuring and have established a normative range of values within the trunk and upper body. Since the establishment of these values, pressure threshold testing has been used extensively in the head, neck, shoulders and spine as a clinical tool and a research aid. There has been little work using it in the lower limb and there are no guideline measurements for the clinician. By establishing a range of values for the foot,this study will enable the clinician to employ pressure threshold measuring as a clinical tool to easily and accurately identify areas of dysfunction and to objectively measure the effectiveness of treatment. It will allow the clinician to establish a degree of improvement or deterioration as it occurs in a patient's condition.

Secondary aims are to examine whether there is a correlation between visual analogue pain scale (VAS) scores and algometric pressure threshold scores for subjects with forefoot pain. This will help validate the tool for use in the foot. Since VAS is well documented and validated, this study will examine whether there is a correlation between VAS and algometry and whether there are gender or age differences in the range of measurements obtained. These areas have been addressed in previous studies but results have been contradictory and inconclusive and none of the previous studies focused on the foot.

An asymptomatic group of 384 subjects \& symptomatic group of 160 subjects shall be selected from those attending a podiatric clinic for routine foot care who meet the inclusion criteria . Outcome me will be algometric pressure threshold testing, visual analogue pain scales and foot function index questionnaires.


Eligibility Criteria:
Inclusion Criteria:

* All patients attending a local podiatric clinic for routine nail care or complaining of forefoot pain

Exclusion Criteria:

* forefoot surgery
* Diabetes
* Rheumatoid Arthritis
* Osteopenia
* All subjects with a diagnosed neurological condition
* Chronic pain at any body location
* Fibromyalgia
Lung Ultrasound Changes in Covid 19 Patients Discharged From Hospital

Lung ultrasound has been used to help diagnose COVID-19 as an alternative to CT scanning and chest X-ray. CT scanning is onerous and there are difficulties taking critically unwell patients there as well as decontamination issues.

Chest X-ray misses up to 40% of COVID diagnoses. Although lung ultrasound can diagnose, the investigators do not know how long these lung ultrasound changes last. The investigators would like to follow up patients to characterise the pattern of changes and how long they last. This is particularly important given a potential second surge of COVID-19 is looming and the investigators would like to know if lung ultrasound changes are new or old in patients presenting during this second wave and in the future.

Ultrasound has been invaluable during this pandemic to diagnose COVID-19. The investigators have used it alongside CT scanning to rationalise the number of CT scans especially when patients are unstable. The investigators do not know how long these changes last on lung ultrasound after discharge and the investigators wish to study this.

This is because patients will start presenting shortly who have a history of COVID-19 with acute medical problems and if the investigators are to use lung ultrasound again the investigators would like to know whether the changes the investigators see are new or old.

This is vitally important before a second surge and especially so before winter. This may also facilitate triage of patients from the front door in the Emergency department to different areas (such as COVID-19 zones or clean areas).

Eligibility Criteria:
Inclusion Criteria:

* 18 years old or older
* Confirmed COVID-19 positive with changes on CXR or CT scan
* Having had an initial lung ultrasound in the Emergency department when they were first admitted into the hospital.

Exclusion Criteria:

* Pre-existing lung disease
* Heart failure
* Under 18 years old.
Smart Walk 50+: Feasibility of a Smartphone-delivered Physical Activity Program for African American Women 50 Years and Older

The purpose of this study is to establish the acceptability and feasibility of a culturally relevant, theory-based smartphone-delivered physical activity intervention among African American women aged 50-65 years.

This study will establish the acceptability and feasibility of a culturally relevant, theory-based smartphone-delivered physical activity intervention among African American women aged 50-65 years. To accomplish this, we will deliver our previously developed Smart Walk physical activity intervention, originally developed for African American women aged 24-50 years old, to 20 sedentary and obese African American women aged 50 to 65. We will collect data on the acceptability and feasibility of the intervention, as well as areas of intervention refinement to enhance the social, cultural, and behavioral relevance of the intervention for women in this age group.

Eligibility Criteria:
Inclusion Criteria:

* Self-reported African American female
* Between the ages of 50 to 65
* Insufficiently Active (less than or equal to 60 mins of moderate-to-vigorous physical activity/week measured by Exercise Vital Sign Questionnaire)
* BMI \> 30
* English speaking and reading

Exclusion Criteria:

* Plans to relocate out of Phoenix area in next 6 months
* Endorsing an item on the PAR-Q, unless a doctor's note for study participation in provided
* Self-reported participation in another diet or weight loss study
* Non-English reading and speaking
* Pregnant or planning to become pregnant in the next 6 months
Personalized Massive Online Open Course After Childhood Cancer

Many studies have shown Childhood Cancer Survivors (CCS) are ill-informed about long-term follow-up (LTFU). Massive open online courses (MOOCs) could easily allow a deployment at an international level and make reliable information available for all CCS, wherever they live. The MOOC team (specialists of LTFU care, communication professionals and CCS associations), bringing together nearly 130 people, designed a MOOC named "Childhood Cancer, Living Well, After" including three modules addressing transversal issues (lifestyle, psychological support, fertility problems) and eight modules covering organ-specific problems.

Detailed data on childhood cancer treatments were used during a study of feasibility in spring 2020 to allocate specific modules to each participant. The aim of the present study is to quantify the impact of this MOOC on the CCS knowledge about LTFU adapted to their own medical history, but also to measure how this MOOC can improve the LTFU care of each CCS.

Eligibility Criteria:
Inclusion Criteria:

* Patient affiliated or entitled to a social security plan,
* Former patient included in the Childhood Cancer Observation Platform (CCOP) for pediatric cancer or leukemia (\<15 years of age) between 2000 and 2010 with at least five years free of anticancer treatment
* Availability of computerized and validated treatment data in the Childhood Cancer Observation Platform (CCOP),
* A subject who has received informed information about the study and digitally signed the online express consent for subjects participating in the MOOC, and digitally signed the online express consent to continue for subjects not participating in the MOOC
* A subject who completed an initial COHOPER survey from Childhood Cancer Observation Platform (CCOP) online self-questionnaire
* Subject who has accepted that data collected as part of the COHOPER survey (including french national health data system (SNDS)) may be reused for scientific research purposes and shared with other research teams,

Exclusion Criteria:

* A subject having already been drawn for the START-MOOC1 feasibility study,
* A subject for whom a doubt, validated by the study coordinating physician, persists on the exact treatment received in childhood and does not allow the allocation of specific modules with certainty,
* A subject who has had several cancers and whose anticancer therapies are not all known,
* A subject who has not been treated in one of the participating referral centers,
* Subject having expressed opposition to the french national health data system (SNDS) interrogation following the sending of the information letter or share the data with other research teams,
* Pregnant