cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Onefit Scleral Lenses in the Mangement of Dry Eye

This study is being conducted to determine if scleral lenses coated with Hydra-PED improve comfort and dryness.

The objective of the study is to determine if scleral lenses with and scleral lenses without Hydra-PEG coating provide positive improvement in ocular comfort and dryness scores.

The effect of the study lenses and the coating, will be compared in a group of symptomatic soft lens wearers, and also in a group of symptomatic non contact lens wearers.

The primary outcome variable for this study is "overall ocular comfort" reported at the screening visit for the habitual vision correction, and at the 4-week follow-up visits for each of the two study lenses. using a 0-10 scale (0.5 steps).

Eligibility Criteria:
Inclusion Criteria:

1. Are at least 17 years of age and have full legal capacity to volunteer;
2. Have read and signed an information consent letter;
3. Are willing and able to follow instructions and maintain the appointment schedule;
4. Agree to wear the study scleral lenses for at least 8 hours per day, 5 days a week;
5. Have a refraction between +20.00 and -20.00D and spectacle astigmatism of no more than -3.00DC in each eye;
6. Have best corrected visual acuity of 20/40 or better in each eye with the study lenses;
7. Demonstrate an acceptable fit with the study lenses;
8. Have no active ocular disease or inflammation;
9. Group 1: Habitual wearer of frequent replacement or daily disposable soft lenses;
10. Group 2: Have not worn contact lenses for 6 months;
11. Group 1: Contact lens wearers should score ≥12 on CLDEQ-8;
12. Group 2: Non contact lens wearers should score ≥13 on OSDI.

Exclusion Criteria:

1. Are participating in any concurrent clinical or research study, or have done so within the past 30 days;
2. Cannot achieve a successful lens fit or vision with the study lens;
3. Have been diagnosed with keratoconus or corneal distortion;
4. Have any known active\* ocular condition, disease and/or infection;
5. Have a systemic or ocular condition that in the opinion of the investigator may affect a study outcome variable e.g. pingueculae;
6. Are using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;
7. Group 2: Non-contact lens wearers who score ≥33 on OSDI and also demonstrate either corneal staining ≥3 (Oxford scale) or non-invasive tear break-up time ≤3 seconds#;
8. Have known sensitivity to the diagnostic sodium fluorescein to be used in the study;
9. Are pregnant, lactating or planning a pregnancy\^ at the time of enrolment, by self report;
10. Have undergone refractive error surgery;
11. Are listed on the Delegation Log for this study.
Remote Training in Evidence-based Practices for Clinicians Who Work With Migrant Workers

This study will compare training as usual to automated training using an intelligent tutoring system in training bachelors (BA) level social workers in cognitive behavioral therapy (CBT). The purpose of the study is to determine if time and cost of training front line clinicians in evidence-based treatments can be shortened, and if this new training model can reduce the need for clinicians to seek advice from experts.

The University of Washington (UW) School of Social Work, in partnership with Heritage University's School of Social Work in Yakima Valley recently partnered to develop a training program for bachelors (BA) level Social Workers to address limited clinician capacity in rural primary care settings. Currently the curriculum is a combination of didactic training in telephone based cognitive behavioral therapy (CBT; 20 hours), role play training (25 hours), and guided supervision. The scalability of these programs is limited, however, by expert time to conduct training activities, clinician time away from work to engage in training activities, and the fact that even when clinicians participate in training, there is no guarantee they will certify. Adaptive learning, an educational method that uses adaptive algorithms to may be a potential solution to these problems in capacity building. These programs can tailor the educational experience to the needs of the trainee, reduce time in training, improve competence in complex decision-making and standardize training. This study builds on the existing research base on clinical training, and adds to it by designing and testing an intelligent tutoring system (ITS) based on adaptive learning algorithms. Both CBT experts (Aisenberg) and past CBT trainees (Heritage University School of Social Work) will partner with experts in educational software development (Popovic) to create the ITS, which will be compared to training as usual on time to training, competence and skill drift. The investigators hypothesize that capacity building through improved learnability (target mechanism) will result in enhanced clinical ability to deliver CBT elements competently, and in a shorter time-period, and that greater competence will result in better quality of care.

Eligibility Criteria:
Inclusion Criteria:

* BA level social work student
* Bilingual Spanish Speaking

Exclusion Criteria:

* none
High Intensity Interval Training in 1% or 10% Slope

The objective was to determine the effect of six running sessions of high intensity interval training (HIIT) at 1% and 10% incline on VO2max, peak of velocity (VPeak), and time limit of 1% (TLim1%) and 10% (TLim10%) of inclination, as well as the influence of the specificity of training on performance in the different inclines.

Our study is assuming greater activation / muscle overload coming from the uphill running. Accordingly, we believe that in a parallel-group design (1% or 10% gradient) established in controlled and randomized way we could answer the hypothesis that muscle overload provide superior gains to VO2max and aerobic performance. Moreover, considering the first hyphotesis, such developments on the running at 10% slope also promote significant gains in climb performance and also in the plan. Unlike the speculate that the gains from the 1% training does not help performance a 10% incline.

Eligibility Criteria:
Inclusion Criteria:

* Minimum standards of physical activity proposed by the ACSM
* Perform running activity at high intensities (HIT)

Exclusion Criteria:

* No cardiovascular problems, respiratory or metabolic
* No muscle or joint injuries
* Not to use drugs or ergogenic resources
Investigating Food Intake Across the Adult Life Course and Relevant Communication Strategies

This project will investigate the effects of different delivery strategies (e.g., personalised dietary advice vs generalised population healthy eating guidance) and individual consumption differences (e.g., eating styles/speeds and food types/preferences) on dietary fibre intake across the adult life-course over a 6-month period.

1. does dietary fibre-related knowledge and intake vary across the adult life-course?
2. what are the common barriers to dietary fibre consumption and how this modulates with increasing age?
3. what is the role of individual consumption differences on subsequent dietary fibre consumption?
4. can targeted dietary advice compared with general population healthy eating guidance delivered by the eNutri app promote dietary fibre intake?

Eligibility Criteria:
Inclusion Criteria

-adults aged 18 years and above

Exclusion Criteria

* health conditions impacting fibre intake (e.g., IBD, IBS, colorectal cancer, Crohns disease, ulcerative colitis, diverticulitis)
* pregnant or breastfeeding
* food allergies/intolerances
* following a weight-loss diet
* no digital device
* living outside of the UK
* cognition impairments (such as dementia)
Late Effects and HRQoL in Survivors of Allo-HSCT - a Cross Sectional Study

The cross-sectional study aims to describe the burden of late effects and survivorship-specific health-related quality of life in a nationwide cohort of patients treated with allo-HSCT in Denmark. Further, identify demographic, medical or personal factors associated with better self-reported health and quality of life.

Objective

The cross-sectional study aims to describe the burden of late effects and survivorship-specific health-related quality of life in a nationwide cohort of patients treated with allo-HSCT in Denmark. Further, identify demographic, medical or personal factors associated with better self-reported health and quality of life.

Method

An observational, descriptive, cross-sectional study using clinical data and self-reported questionnaires to assess the occurrence of comorbidities and self-reported late effects in survivors treated with allo-HSCT in Denmark between 1970 and 2024.

Study population

All survivors treated for malignant or non-malignant hematological disease with allo-HCST at the age of 18-79 years from 1970-2024 in Denmark are eligible (n=1.436).

Endpoints

* Self-reported survivorship specific HRQoL measured by EORTC-QOL- Survivorship 100.
* Degree of health literacy measured by the Health Literacy Questionnaire (HLQ).
* Occurrence or degree of Chronic Graft Versus Host Disease measured by modified Lee Chronic Graft versus host disease Symptom Scale.

Eligibility Criteria:
Inclusion Criteria:

* All survivors treated for malignant or non-malignant hematological disease with allogeneic hematopoietic stem cell transplantation at the age of 18-79 years from 1970-2024 in Denmark are eligible

Exclusion Criteria:

* Patient unable to read and understand danish are excluded from study participation
Sub vs Trans-umbilical Incision: A Patient's Satisfaction-centered Trial

While some studies have suggested that subumbilical and transumbilical incisions have a similar clinical efficiency and safety, no study has yet evaluated their respective impact on patient's postoperative aesthetic satisfaction.

The objective of this randomised trial is to compare patient's postoperative aesthetic satisfaction depending on the type of incision which is performed during surgeries.


Eligibility Criteria:
Inclusion Criteria:

* Patients 18-70 years old having a planned laparoscopic surgery with an umbilical first trocar at CHUS were included.

Exclusion Criteria:

* Patients with a BMI \> 40 or that had previous abdominal surgeries involving the umbilicus were excluded.
Botulinum Toxin Injection in Epicardial Fat Pads To Treat Atrial Fibrillation After Cardiac Surgery

The aim of this prospective randomized double-blind study was to compare the efficacy and safety of Botulinum toxin injection in epicardial fat pads for preventing recurrences (in early postoperative period) of atrial tachyarrhythmia in patients with paroxysmal atrial fibrillation undergoing coronary artery bypass graft (CABG) surgery.


Eligibility Criteria:
Inclusion Criteria:

* PAF
* Indication for CABG according to the American College of Cardiology/American Heart Association (ACC/AHA) guidelines for CABG surgery

Exclusion Criteria:

* Previous heart surgery and AF ablation procedure
* Emergency CABG
* Unstable angina or heart failure
* Persistent AF, AF at the time of screening (planned Maze procedure or pulmonary vein isolation)
* Use of I or III antiarrhythmic drugs within 5 elimination half-lives of the drug (or within 2 months for amiodarone)
* Requiring concomitant valve surgery
* Left ventricle ejection fraction \<35%
* Left atrial diameter \>55 mm
* Unwillingness to participate
A Prediction Model of Hematological Recovery After High-dose Chemotherapy in Pediatric Solid Tumor

This study aims to compare and evaluate the predicted values of the participants, and the algorithm predicted values of ANC level reduction periods after high-capacity chemotherapy in pediatric solid tumor patients. The participants are pediatricians who voluntarily participate in this study and consent to this study.

n pediatric patients with solid tumors, chemotherapy for radical treatment is generally based on monitoring white blood cells, red blood cells, and platelets with repeated blood tests during treatment due to bone marrow depression.

Early blood culture and experiential intravenous antibiotics are required to prevent progression to sepsis if fever or other infection signs are accompanied by a decrease in absolute neutrophil count (ANC) below 500/mm3. In addition, repeated blood transfusions are needed to keep the appropriate levels constant depending on clinical symptoms in platelet reduction or anemia.

In particular, in the case of high-dose chemotherapy conducted on high-risk tumors, anticancer drugs are given over the dose expected to recover natural bone marrow function to improve the treatment performance of tumors responding to chemotherapy. Moreover, it is challenging to recover naturally after high-dose chemotherapy so that the collected in advanced hematopoietic stem cells are implanted into the patient to support ANC level recovery.

However, despite the transplantation of these self-hematopoietic stem cells, some patients need long-term continuous blood transfusions due to delayed hematological recovery and may need long-term hospitalization to treat accompanying infections and complications.

The researcher developed a model that can predict the suppression and hematological recovery of bone marrow after high-capacity anticancer drugs by analyzing blood tests and blood transfusions repeatedly from the diagnosis of pediatric solid tumors after high-capacity chemotherapy collected from 2000-2018.

Eligibility Criteria:
Inclusion Criteria:

* physician who is working at Samsung Medical Center as a pediatric doctor
* A person who voluntarily agrees to participate in the study

Exclusion Criteria:

* Those who disagree with the study
A Prospective Study to Observe Adverse Effects in Patients Receiving Anti-PD1 Immunotherapy

The goal of this observational study is to learn about in the development process of adverse reactions of anti-PD1 immunotherapy. The main question it aims to observe:

* The autoantibody profile of patients
* The adverse reactions of patients
* The changes of immune cells and cytokine in patients

The goal of this observational study is to learn about the development process of adverse reactions of anti-PD1 immunotherapy. The main question it aims to observe:

* The autoantibody profile of patients
* The adverse reactions of patients
* The changes of immune cells and cytokine in patients (e.g., T cell, B cell, IL-6, etc.)

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years old.
2. Receiving anti-PD1 immunotherapy

Exclusion Criteria:

1. Vital signs are unstable
2. Functional impairment of immune system caused by other diseases or other reasons, such as Systemic lupus erythematosus (SLE), AIDS, etc.
A Study of Adipose Tissue in Adaptive Responses to Exercise

The purpose of this research is to determine how exercise affects fat (adipose) tissue and how changes to adipose tissue that occur during and after exercise might improve health in aging and obesity.

Adipose tissue has important endocrine functions that influence metabolic health. Early evidence shows that adipose adapts to physiological stress, including exercise. The objective here is to determine how exercise-induced alterations in adipose tissue cellular composition and endocrine signaling may contribute to the beneficial adaptations to exercise in aging and obesity.

Immune cell populations and inflammatory signatures will be assessed in subcutaneous abdominal adipose tissue biopsies collected from obese and normal weight young and older adults before, immediately after, and 3 hours after a 30-min bout of cycling exercise at 70% of maximal oxygen consumption (VO2max). Mass spectrometry, Olink targeted inflammation assays, and RNA sequencing will be used for full proteomic and transcriptomic characterization of the adipose tissue secretome (the proteins and molecules secreted from the adipose tissue) and the cargo of extracellular vesicles isolated from plasma and media collected from cultured human adipose tissue explants generated from each time point.

Overall, the primary hypothesis of the proposed work is that a single bout of exercise triggers transient changes in adipose tissue paracrine/endocrine signals and immune cellular composition. The investigators propose that these responses contribute to the beneficial effects of exercise locally and in distal tissues and that the cumulative effects of acute changes in adipose tissue likely contribute to the positive alterations in adipose tissue associated with exercise training.

Eligibility Criteria:
Inclusion Criteria:

* Adults between the ages of 18-35 OR 65-85.
* BMI 18.5 kg/m2 - 40 kg/m2
* Weight stable (≥ 3 months)
* Generally healthy

Exclusion Criteria:

* Participation in ≥ 30 minutes of structured physical activity ≥ 2 days per week.
* Smoking/tobacco use.
* Alcohol/substance abuse.
* Pregnancy and breastfeeding.
* Anemia.
* Abnormal renal function.
* Blood clotting disorders.
* Coronary artery disease.
* Uncontrolled thyroid disease.
* Liver disease.
* Use of medications known to influence the main outcomes of the study.
* Orthopedic problems that may be aggravated by exercise.
* Chronic disease at the discretion of the investigators.
A Phase II Study of Lonsurf (TAS-102) in Metastatic Platinum and Checkpoint Inhibitor-resistant Bladder Cancer

This study evaluates the clinical benefit of TAS-102 in participants with metastatic urothelial carcinoma who are resistant to cisplatin or carboplatin front-line and checkpoint inhibitors as second line therapy. All participants will receive TAS-102 in oral form twice per day on Days 1-5 and Days 8-12 of each 28 day cycle.


Eligibility Criteria:
Inclusion Criteria:

* Ability of participant to understand this study, and participant willingness to sign a written informed consent.
* Participants must have histologically or cytologically confirmed locally advanced unresectable or metastatic urinary bladder (urothelial) cancer. Participants with mixed histologies are permitted as long as transitional cell carcinoma is present in the pathological specimen.
* Participants must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension
* Documented progression on or within 12 months of treatment with one previous platinum-containing regimen or ineligible to receive platinum-containing regimen. Neo-adjuvant or adjuvant platinum-based chemotherapy will be deemed to be first-line when participants progressed within 12 months of the last dose
* Documented progression on prior checkpoint inhibitor or ineligible to receive check-point inhibitor
* Adequate performance status, organ, and marrow function.
* Women of child-bearing potential and men with partners of child-bearing potential must agree to practice sexual abstinence, or to use two forms of adequate contraception.
* Men of child-bearing potential must not father a child or donate sperm while on this study and for 6 months after their last study treatment

Exclusion Criteria:

* Patients who have had chemotherapy or radiotherapy within 4 weeks of enrollment/registration.
* Current or anticipated use of other investigational agents while participating in this study.
* Psychiatric illness/social situations that would limit compliance with study requirements.
* Pregnant or breast feeding (if applicable).
* Patients with known brain metastases
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to TAS 102.
* Patients with HIV on anti-retro-viral therapy with thymidine kinase substrates, for example, stavudine, zidovudine, telbivudine.
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia. Undergoing active treatment for a co-existing malignancy with the exception of adequately treated basal cell carcinoma, squamous cell skin cancer, thyroid cancer or incidental prostate adenocarcinoma detected at radical cystectomy
Micro- and Macro-Circulation in Cardiac Surgery Patients

The hypothesis under the study is that there could be a link between a dysfunction in peripheral microcirculation, sublingual microcirculation or cardiovascular control and the development of post cardiac surgery major morbidities (stroke, acute kidney injury, prolonged intubation, mediastinitis, surgical reopening, death).

The state of sublingual microcirculation, of peripheral microcirculation and cardiovascular control will be assessed in 100 patients undergoing cardiac surgery during general anesthesia before the intervention and at the end of the intervention at the arrival in post-surgery ICU by means of signal processing techniques.

The extracted markers will be used to assess a statistical prediction model of major morbidities.


Eligibility Criteria:
Inclusion Criteria:

* age \>18 yrs
* indication for a cardiac surgery intervention
* spontaneous sinus rhythm
* informed consent

Exclusion Criteria:

* know autonomic nervous systems pathologies or dysfunctions
* pregnancy
US PROmyBETAapp2.0: A Study to Learn More About the Medication Usage and Patient Reported Outcomes Via the myBETAapp in Medical Care of Patients With Multiple Sclerosis Treated With BETASERON Using BETACONNECT Autoinjector

In this study researchers want to learn more about the medication usage behavior among multiple sclerosis (MS) patients treated with BETASERON using the myBETAapp. Multiple sclerosis (MS) is a disease in which the covering called "myelin" around the nerves of the central nervous system degenerate. MS is a lifelong disease therefore requiring continuous treatment to delay the disease progression and reduce the rate of relapse (the return of signs and symptoms of). BETASERON is an approved medicine used to reduce the relapse in patients with MS. It is injected into the tissue under the skin using BETACONNECT autoinjector, which automatically captures injection data including injection date, time, speed, and depth and uploads the data into paired myBETAapp. This allows patients to organize and track their progress and share the injection information with their physicians. The medication usage behavior to be collected in this study includes the elements to what extent

* taking medication matches the presciber's recommendation (adherence, compliance),
* treatment for the prescribed duration (persistence) is continued and
* injections were missed. Among MS patients treated with Betaferon using the myBETAapp the study will also collect information on the health-related quality of life , treatment satisfaction and satisfaction with treatment support.


Eligibility Criteria:
Inclusion Criteria:

* Aged ≥18 years
* Treated with BETASERON using the BETACONNECT autoinjector
* Registered with myBETAapp
* Provided electronic informed consent

Exclusion Criteria:

- There are no exclusion criteria for participation in this study