cyrilzakka/clinical-trials huggingface dataset:
Conjunctival Rebound After Scleral Lens Wear

Scleral lenses, customized rigid contact lenses that land on the soft and spongy conjunctival tissue overlying the sclera, will be fitted on 15 subjects with normal ocular surfaces. The purpose of the study is to determine the amount of conjunctival compression caused by the devices and the length of time required for the shape to recover from compression.

The purpose of this study is to determine the interval required for the conjunctival tissue to return to its natural shape after scleral lens wear. All study visits will take place at the University of Houston College of Optometry (UHCO). Subjects will be recruited and fitted with scleral lenses to wear during the experimental days. Once the proper fit has been achieved, subjects will wear the scleral lens for 4 days total, returning after the 1st and 4th day of lens wear for approximately 2 hours of testing. The subjects will then return every 24-hours for measurements until their conjunctival shape has returned to the original shape. The testing will be done using the sMap scleral topographer, which measures the elevation of the conjunctiva. Testing is non-invasive although it requires instillation of Fluress eye drops, a sodium fluorescein dye with anesthetic that allows for imaging. The total number of visits is 9-14 and the length of visit ranges from 10 minutes to 2.5 hours.

Eligibility Criteria:
Inclusion Criteria:

* Normal ocular surface without conjunctival or scleral disease
* Male or female
* 18 years of age and older prior to the initial visit
* A non-scleral lens wearer.

Exclusion Criteria:

* Individuals with anterior segment ocular pathology that may affect intraocular pressure and/or scleral/conjunctival health.
* Individuals with known adverse response to Fluress® ophthalmic drops
* Individuals with a history of habitual scleral lens wear
* If a usable baseline image is unable to be obtained at the initial visit due to small ocular surface area or eyelid anatomy
* Individuals currently taking any ocular medications that could affect intraocular pressure and/or scleral/conjunctival health
* Individuals who have any other conditions or situations which, in the investigator's opinion, may put the subject at significant risk, may confound study outcomes, or may significantly interfere with the subject's participation in the study
Influenza Vaccine in Lung Transplant Patients - T Cells

This a sub-study of a 5-year study designed to investigate how antibody and T cell responses following influenza vaccine compare among lung transplant patients, patients waiting for lung transplantation, and healthy individuals.

This trial is designed to investigate the hypothesis that there is no difference in T Cell response to the influenza vaccine between lung transplant patients and healthy controls.

Influenza virus infection causes significant morbidity and mortality each season. The infection is particularly serious in the elderly and those with chronic cardiopulmonary conditions. Solid organ transplant recipients receiving immunosuppressive therapy may be at particularly high risk for serious influenza infection. Lung transplant patients may have an even higher risk because of their underlying pathophysiology.

Influenza prophylaxis is extremely important in the care of the transplant patient. Annual influenza immunization is recommended because protection is short-lived and the vaccine composition changes. However, the efficacy and effectiveness of this intervention is largely unproven. Not surprisingly, studies have shown that lung transplant patients have lower antibody responses than healthy individuals do. To this end, this study tests the hypothesis that the influenza vaccine-induced T cell responses will be similar in lung transplant patients and healthy individuals.

Blood will be drawn prior to and 2-4 weeks after immunization and used to measure antibody responses by hemagglutination inhibition assay.

Samples will be collected in Jan-April each season to study Trans-vivo Delayed Type Hypersensitivity (TVDTH) response.

\[This substudy that was originally registered to NCT00205270 and subsequently registered to its own NCT number for the purpose of clarity in linked results\]

Eligibility Criteria:
Inclusion Criteria:

* Post-lung transplant at University of Wisconsin Hospital
* Healthy adult

Exclusion Criteria:

* Allergy to eggs
* Moderate to severe febrile illness
* Active treatment for acute rejection
* Received season's influenza vaccine prior to enrollment
Central Catheters Used for Chemotherapy in Women With Breast Cancer

The overall aim of this study is to evaluate two different central venous lines, PICC-lines (PICC) and subcutaneous venous access ports (SVAP) used for chemotherapy in women with breast cancer. The study will compare complications, material wear of the catheters used, patients'- and health care professionals' experiences, and costs. The study will give knowledge about which central venous access that is the most advantageous regarding adjuvant chemotherapy for women with breast cancer in the aspects of safety, quality of care, and quality of life.

N=250 women between 18 and 70 years of age with invasive breast cancer who are allocated to adjuvant or neo adjuvant chemotherapy during 18 weeks at the Department of Oncology at Karolinska University Hospital , Stockholm Sweden are eligible to participate in the present study. Exclusion criteria are cognitive dysfunction and/or inability to understand Swedish. Before participation an informed consent will be collected. The patients will be randomized to receive a PICC or a SVAP. Complications will be registered as well as the treatments.

Bacterial cultures will be taken at removal of PICC/SVAP. The used PICC/SVAP will be transported to the Royal Institute of Technology (KTH) and subjected to material analyses. Comparison with reference materials from the in-vitro study and with new reference catheters will be performed. Patient assessments with questionnaire concerning HRQL, illness perception, body imaging, life style and sleep disturbance will be collected at baseline and at the last chemotherapy session. Interviews with the patients about life situations will be conducted half through the chemotherapy treatment period.In- and out-patients costs, i.e. medication, materials, costs related to the care of the PICC/SVAP, costs for complications, additional costs for the patients regarding the treatment, etc., will be monitored and registered. In- and out-patient costs will also be monitored. Data from medical records concerning treatments for complications will also be taken into consideration.

Eligibility Criteria:
Inclusion Criteria:

* adjuvant or neo adjuvant chemotherapy,
* speak Swedish

Exclusion Criteria:

* cognitive dysfunction
* and/or inability to understand Swedish,
* recurrent breast cancer
Utility of Multisensory Body-Representation in Spinal Cord Injury (SCI) With Pain

The purpose of this study is to investigate the effectiveness of bodily illusions combined with transcranial direct current stimulation (tDCS) on neuropathic pain symptoms and sensory functions in participants with spinal cord injury (SCI) and neuropathic pain.


Eligibility Criteria:
The study will be open to people of any ethnicity, racial background, and gender.

Inclusion criteria:

SCI with Pain:

1. Men or women
2. fluent in English
3. 18-70 years of age who have: (3a) Complete and incomplete SCI, level of injury (above L1); (3b) Persistent neuropathic pain started after the injury for a minimum of three months prior to entering the study that is at least moderate in severity, defined as ≥ 4 on a Numeric Rating Scale (NRS) ranging 0 to 10.

Exclusion criteria:

Participants will be excluded if they have:

1. Major psychiatric disease/disorder (self-reported);
2. a significant neurological trauma (self-reported) other than SCI;
3. a recent (one-year) history of alcohol or drug abuse assessed by the Drug Abuse Screening Test (DAST-10)
4. history of visual and hearing loss not corrected
5. history of epilepsy or seizures
6. any metal implants in the head, or implanted devices such as cochlea implants or cardiac pacemakers.

We will not include any special population like:

Adults unable to consent Individuals who are not yet adults (infants, children, teenagers) Pregnant women Prisoners
A Prospective Cohort Study on Drug-induced Liver Injury in China（DILI-P）

This is a multi-center, prospective, non-interventional cohort study .

Its primary objectives are:

1. assess DILI patients' clinical characteristics, disease progression and influencing factors in clinical practice;
2. learn about suspected drug caused DILI,rechallenging, liver biochemical abnormalities mode, etc.

The main purpose of this study is to understand patients with DILI clinical outcome and influencing factors in China's second and tertiary general hospitals (including Western medicine hospital, Chinese medicine hospital andIntegrated traditional Chinese and Western Medicine Hospital) and vulnerabilities of drug-induced liver injury specialist hospital (tuberculosis hospital, Pulmonary, etc.) in mainland.

The main purpose

1. assess the DILI patients' clinical outcomes and influencing factors in the real world;
2. learn about suspected drug caused DILI,rechallenging, liver biochemical abnormalities mode, etc.

Secondary objectives

1. assess the compliance of the DILI practice to the 2015 vision of the DILI guidelines in china.;
2. evaluate the histological features of DILI patients;
3. assessment DILI characteristics, prognosis and influencing factors in specific populations(such as the elderly, children with underlying liver disease background, etc.)

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of DILI patients with various types and severity according to the 2015 version of the Chinese DILI treatment guidelines
* RUCAM ≥6, or RUCAM between 3-5 is required by the three experts determined that the drug-induced liver injury
* patient can provide informed consent form

Exclusion Criteria:

* non-drug-induced liver injury
Remote Home Monitoring Acute Pancreatitis

Acute pancreatitis is an inflammation of the pancreas which causes abdominal pain and is the most common gastro-intestinal reason for acute hospitalization in Western countries. Because care for a mild acute pancreatitis is supportive, early discharge of patients with a predicted mild course of acute pancreatitis might be safe with the use of remote home monitoring. This might reduce the demand for hospital beds and allow patients to benefit from recovering in their home environment. Therefore, the aim of this study is to assess the feasibility of a novel care pathway in which patients with a predicted mild course of acute pancreatitis are discharged early with remote home monitoring.


Eligibility Criteria:
Inclusion Criteria:

* Have 2 out of 3 revised Atlanta criteria for pancreatitis:

  * Abdominal pain consistent with acute pancreatitis
  * Serum lipase ≥ 3x upper limit normal (\> 159 U/l)
  * Typical pancreatic abnormalities on imaging (ultrasound, CT or MRI)
* First episode of acute pancreatitis or a prior pancreatitis more than 3 months ago.
* Age ≥18 years, both men and women.
* Able and willing to provide written informed consent.
* In possession of a working (smart)phone on which patient can be reached for the duration of participation (30 days).

Exclusion Criteria:

* Chronic pancreatitis according to M-ANNHEIM criteria (20).
* Signs of severe pancreatitis at the moment of admission to the GE ward:

  * Serum CRP \> 150 mg/l
  * More than one SIRS criteria:

    * temperature \< 36◦C or \> 38◦C
    * heart rate \> 90/min
    * respiratory rate \>20/min
    * leucocytes \< 4x/109l or \> 12x109/l
* MEWS (Modified Early Warning Score) ≥6 or in need of ICU admission
* Living alone or in an institution (e.g. psychiatric ward or nursing home)
* Known sensitivity to medical adhesives
* Known pregnancy
* Have one or more of the following comorbidities:

  * Heart failure (NYHA class III or IV)
  * COPD (Gold III-IV)
  * Kidney disease (\>G3b) and/or kidney replacement therapy
  * Currently undergoing oncological treatment
  * Use of immunosuppressants
  * Dysregulated or poorly controlled insulin dependent diabetes
  * Morbid obesity (BMI\>35 kg/m2)
  * Implantable Cardioverter Defibrillator (ICD) or Pacemaker
The HIIT-Home4Parkinson's Study

This project aims to investigate the practicality and utility of home-based high-intensity interval training (HIIT) by undertaking a previously developed, novel home-based HIIT intervention for people with Parkinson's (PwP).

This is a randomised controlled feasibility study with mechanistic, physiological and clinical sub components.

Participants will be undertaking a 12-week home-based high-intensity interval training intervention. The programme is a feasibility study, previously co-created by people with Parkinson's and clinicians within an iterative planning process of focus groups and exercise testing.

Following recruitment, participants will undertake initial baseline assessments. These will involve collection of anthropometric measurements and general lifestyle and Parkinson's related information, followed by pre-intervention mechanistic, physiological and clinical outcome measures. Participants will then be randomised to the HIIT intervention, or usual care control group.

Both groups will then undertake 7 days pre-intervention physical activity monitoring following accelerometer instruction, as a baseline measure of habitual physical activity (an important confounding variable).

Following an initial home visit, participants will then undertake a 12-week high-intensity interval training programme in the home setting, with supplied exercise equipment including music and exercise prompts, and remote support and online resources. Participants will complete a 32 minute training session 3 times per week, with at least one day of rest between sessions. Participants will be loaned heart rate monitoring devices, which will remotely record heart rate per exercise session. During week 7 of the intervention, participants will be asked to repeat 7 days of accelerometer wearing to compare habitual physical activity. Participants will record feasibility and safety aspects such as HIIT participation / adverse effects and events / exercise adaptations in diaries during the course of the intervention.

Participants will then undergo post-intervention outcome measures. Participants will also be asked to be involved in a 45-minute post intervention focus group as part of a process evaluation. Depending on numbers, it is likely that there will be 2 of these parallel groups.

Eligibility Criteria:
Inclusion criteria:

* Diagnosed with Parkinson's disease
* Aged 18 years or older (No upper limit)
* Hoehn and Yahr stages 1-3 (Mild to moderate disease severity)
* Capacity to consent under the Mental Capacity Act 2005, and able to follow an exercise programme
* Based at home with enough space to perform an exercise programme
* Willing and able to travel to intervention assessments
* Access to a computer, Smart Phone, or tablet and to the internet.

Exclusion criteria:

* Other concurrent neurological condition
* Co-morbidities that would prevent / be exacerbated by high-intensity exercise such as forms of cardiovascular disease
* Advised to not participate following medical consultation
* Participation in a contemporaneous interventional study
Fostering Optimal Regulation of Emotion for Prevention of Secondary Trauma (FOREST)

FOREST is a positive emotion skills program designed to target mental health and coping needs for frontline violence prevention workers at UCAN. Ten skills are taught over a period of nine months during existing meetings and wellness activities, as well as in online modules in UCAN's Learning Management System (LMS). Through infusing the FOREST skills throughout UCAN, we hope to inspire organizational culture change that will emphasize the importance of wellbeing and enhance resilience, therefore reducing burnout and turnover.

All frontline UCAN staff will receive the FOREST program. Each month for 9 months there will be a focus on one to two positive emotion skills. The skill(s) of the month will be taught to the staff during existing one-hour wellness meetings/activities, and will be co-facilitated by Positive Emotion Ambassadors (PEAs; UCAN Staff members nominated to infuse the skills into UCAN culture) and Northwestern University.

The skill sessions will include didactic content defining the skill and explaining the rationale for inclusion, as well as examples of existing research demonstrating the skills benefits. During the session the group will practice the skill together and discuss ways to use the skill in both work and personal situations. Throughout the month, PEAs will implement the FOREST skill of the month in other existing meetings, check-ins, and team outings

The monthly sessions will be observed by a member of the Implementation Resource Team (IRT) who will use a checklist to track that all core pieces of the skill training were delivered. Once a month, the IRT will meet with the PEAs for additional training and support. These sessions will be audio recorded for qualitative data on facilitators and barriers to the skill.

Each month a module in UCAN's learning management system (LMS) that covers that month's skill(s) will also become available. The LMS modules will contain skill-related content similar to what is taught in the skill sessions, including a thorough definition of the skill, examples of ways to utilize the skill, a review or summary of the skill, and several knowledge questions to check for comprehension. The LMS content may include text, audio, images, and video components. All UCAN frontline CVI staff will be required to complete the LMS FOREST skill module of the month. Percentage of staff completing each LMS training will be tracked.

Annual assessments to assess primary and secondary outcomes will be administered via REDCap. Annual interviews and focus groups will ask for feedback on implementation and content.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 and over
* Currently employed by UCAN
* Has internet access
* Speaks and reads English

Exclusion Criteria:

* None
Dino Egg in Neonatal Intensive Care Unit

Dino EGG mother's voice exposure and multisensory processing in Neonatal Intensive Care Unit infants.

This is a 2 phase prospective comparative effectiveness trial of our parents' voice intervention with 290 hospitalized preterm infants.

As a part of a previous project, an early technology development award from the Nationwide Children's Hospital (NCH) Technology Office allowed us to develop 10 functioning prototypes of the DINO EGG speakers, a NICU-safe and developmentally appropriate music player that delivers parent's voice to the bedside of NICU infants. The device passed NCH NICU-safe products committee and has been used in the clinical setting delivering clinical music therapy services (available at bedside to play parents' voice).

The first phase of the current study is to test an updated prototype version of the device that replicates a previously FDA (and NCH NICU-safe products) proved device called Pacifier Activated Lullaby (PAL), used and described in IRB15-01035, but being discontinued by the company. The discontinuation is not due to safety or health benefits concerns. Therefore, no device available on the market currently exists to accomplish NICU parents' voice delivery in a consistent and safe manner, the investigators modified a 510K-approved feeding device that is no longer available and whose intellectual property rights have expired. The device's air displacement sensor, which fits into a standard NICU pacifier, allowed the investigators to deliver processed and developmentally appropriate recordings of parent's voice, contingent upon the infant producing effort to receive it. Intellectual property rights were filed for the modifications and use process through the technology transfer and legal office at NCH.

Therefore, phase I will test the usability of the device (safety for the NICU was confirmed), not the effectiveness of the parents' voice delivery for the infant. Parent and nursing questionnaires about the importance of the device availability and its usability will be collected from parents and Registered Nurse (RN) staff that choose to provide the feedback.


Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria will be Post Menstrual Age (PMA) 32 0/7-34 6/7.

Exclusion Criteria:

* Ventilation using an endotracheal tube
* Major congenital malformations
* Family history of genetic hearing loss
* Use of sedatives or seizure medications
* Presence of severe neural injury on neuroimaging (intraventricular hemorrhage grade II or IV, periventricular leukomalacia, cerebellar hemorrhage, ischemic or thrombotic injury)
* Presence of systemic inflammatory conditions (history of necrotizing enterocolitis Bell's stage IIA or above or culture-documented sepsis or meningitis).
Evaluating and Improving Functional Driving Vision of Patients With Astigmatism: Phase 3

It is a common clinical practice to leave small amounts of astigmatism uncorrected in contact lens wearers. Therefore, some drivers who have astigmatism and wear contact lenses may experience blur while driving. The purpose of this study is to determine if correcting small amounts of astigmatism with contact lenses will improve driving safety.

The purpose of this randomized control trial is to compare visual performance and simulated driving performance of adults with astigmatism when wearing 1\*DAY ACUVUE® MOIST for ASTIGMATISM (toric), 1\*DAY ACUVUE® MOIST (spherical control), and 1\*DAY ACUVUE® MOIST (placebo) contact lenses. Adult subjects with nearsightedness and astigmatism will wear three types of soft contact lenses (placebo, spherical and toric in randomized order). Each subject will read letters on standard eye charts and complete vision and driving tests in a driving simulator. Subjects will repeat these tests with each lens type. Analyses will include an ANOVA to look for a main effect of lens condition, and separate contrasts to compare toric vs. spherical, toric vs. placebo, and spherical vs. placebo lenses. Investigating the lenses under simulated driving conditions, which involve eye movement demands, will lend insight into the potential advantages of toric over spherical contact lenses for driving safety.

Eligibility Criteria:
Inclusion Criteria:

* Adult licensed driver
* Ages 18-39 years
* Corrected vision of 20/40 or better in each eye
* Astigmatism between 0.75 and 1.75 diopters in each eye
* Nearsightedness between 0 and -9 diopters in each eye
* No active eye infection
* No defective peripheral vision
* No bifocal correction
* Routinely wears toric contact lenses (more than 4 times per week)
* Routinely drives a car (more than 4 times per week)
* No history of motion, sea, or big screen (e.g. IMAX) sickness, and no persistent Simulation Adaptation Syndrome

Exclusion Criteria:

* Corrected vision worse than 20/40 in either eye
* No astigmatism in either eye
* Active eye infection
* Defective peripheral vision
* Wears bifocals
* Wears contact lenses less than 4 times per week
* Drives infrequently (less than 4 times per week)