cyrilzakka/clinical-trials huggingface dataset:
Corneal Collagen Crosslinking for Keratoconus and Ectasia Using Riboflavin/Dextran or Riboflavin/Methylcellulose

This study is being conducted to evaluate the safety and efficacy of isotonic riboflavin for corneal collagen crosslinking for keratoconus and corneal ectasia. will determine the safety and efficacy of corneal collagen crosslinking (CXL) performed with two different riboflavin formulations for reducing corneal curvature.

This study will determine the safety and efficacy of corneal collagen crosslinking (CXL) performed with two different riboflavin formulations for reducing corneal curvature. Subjects will be randomized to one of 2 groups. One group will be treated with a methylcellulose riboflavin solution and the other group will be treated with a dextran riboflavin solution. Both groups will be exposed to 3mW/cm2 of continuous UVA light for a total of 30 minutes; each group will continue to be administered the designated riboflavin drops during UV exposure.

The primary efficacy parameter that will be evaluated over time is maximum keratometry (Kmax) in the randomized eyes for each treatment group.

The secondary efficacy parameter will be to determine if the two treatment groups equivalent in their Kmax change at 12 months after treatment compared with baseline.

Eligibility Criteria:
Inclusion Criteria:

* 12 years of age or older
* Having a diagnosis of keratoconus or corneal ectasia after corneal refractive surgery
* Presence of central or inferior steepening on the Pentacam map
* Axial topography consistent with keratoconus or post-surgical corneal ectasia
* Contact lens wearers only: removal of contact lens for the required period of 1 week prior to the screening refraction
* Signed written informed consent
* Willingness and ability to comply with schedule for follow-up visits

Exclusion Criteria:

* Eyes classified as either normal, atypical normal, or keratoconus suspect on the severity grading scheme
* Corneal pachymetry less than or equal to 300 microns at the thinnest point measured by Pentacam in the eye(s) to be treated
* Previous ocular condition (other than refractive error) in the eye(s) to be treated that may predispose the eye for future complications, for example: History of corneal disease (e.g., herpes simplex, herpes zoster keratitis, recurrent erosion syndrome, corneal melt, corneal dystrophy, etc.) Clinically significant corneal scarring in the CXL treatment zone
* A history of chemical injury or delayed epithelial healing in the eye(s) to be treated
* Pregnancy (including plan to become pregnant) or lactation during the course of the study
* A known sensitivity to study medications
* Patients with nystagmus or any other condition that would prevent a steady gaze during the CXL treatment or other diagnostic tests
* Patients with a current condition that, in the investigator's opinion, would interfere with or prolong epithelial healing
The Impact of Lifestyle Medicine on the Sense Of Coherence and Biological Age in a Community Sample

This two-arm, pilot, cross-over randomized controlled trial took place at Diabetes Laboratory, First Department of Propaedeutic Internal Medicine, Laikon General Hospital, School of Medicine, National and Kapodistrian University of Athens, Athens, Greece the from February 2024 to June of 2024. The study protocol was approved by the Ethics Committee of First Department of Propaedeutic Internal Medicine, Laiko General Hospital(Protocol no 2401/February 27,2024)and was consistent with the Helsinki Declaration for human studies.

Pythagorean Self-Awareness Intervention (PSAI) to a sample of community volunteers without pre-existing pathology, with the aim of evaluating the effectiveness of PSAI compared to a control group. Primary goals are to improve lifestyle (6 pillars), increase sense of coherence, improve telomere length and reduce perceived stress. Secondary goals are to reduce negative emotions, fatigue, neuroticism and inflammation. Also, the increase in self-efficacy, emotional intelligence, health locus of control, satisfaction with life and finally the improvement of memory and blood pressure. Measurements will take place in both groups before and after the intervention and included: Self-report questionnaires for measuring psychometric and lifestyle factors, cognitive assessment, body measurements, hair cortisol concentrations and blood sampling for telomere length.

Eligibility Criteria:
Inclusion Criteria:

* Clinically healthy adults
* Speaking and writing in Greek language

Exclusion Criteria:

* Participation in another stress management trial
* diagnosis of any serious mental disorder
* short-term or long-term treatment with corticosteroids
* drug addiction
Vertical Ramus Osteotomy With Iliac Graft Versus Sagittal Split Osteotomy

* Patients will be collected from faculty of dentistry
* bilateral vertical ramus osteotomy (VRO )with iliac graft group (group I):- 10 patients will be treated via VRO and iliac crest or
* bilateral sagital spilt osteotomy (BSSO) group (group II):- 10 patients will be treated via BSSO
* All patients will be studied by comprehensive clinical oral and maxillofacial examination and lateral cephalometric radiographic analyses, within 1 week before the surgery (T0), immediately after the surgery (T1), and 6 months after surgery (T2).
* All lateral cephalometric radiographs and clinical photographs must be standardized for all cases.
* After pre-surgical orthodontic treatment , a lateral cephalograph Will be obtained for planning the surgical movement of both jaws
* Surgical models and surgical stent will be fabricated.
* All surgical procedures will be performed under nasal intubation and general anesthesia to surgically reposition the maxilla in standard LeFort I setback fosteotomy; the BSSO group will be underwent BSSO, and VRO group will be underwent VRO
* The bony segments will be fixed in the new position with the use of custom made plates (specific for each patient )


Eligibility Criteria:
Inclusion Criteria:

* patients with age above 18 years old suffered from skeletal class II with severe mandibular deficiency

Exclusion Criteria:

* patients with chin deviation,
* severe temporomandibular joint (TMJ) symptoms.
* Sever periodontal disease
* pregnancy,
* previous mandibular surgery,
* inability to follow-up for the study protocol
Enhanced External Counterpulsation on Delayed Onset Muscle Soreness

This study will evaluate the effects of Enhanced External Counterpulsation on delayed onset muscle soreness. The primary outcomes will be duration of delayed onset muscle soreness, WBC count, CRP count, CPK count, and pain tolerance.


Eligibility Criteria:
Inclusion Criteria:

* Healthy active Duty or DoD beneficiaries between 25 and 59 years old

Exclusion Criteria:

* Not on a physical profile
* Not taking any OTC or prescription pain medications or workout supplements
Assessment of the Anesthetic Effect on the Activity of Immune Cell in Patient With Colon Cancer

Anesthetics agents has variety inflammation during the cancer surgery. This perioperative inflammation can influence to cancer metastasis or recurrence.

The purpose of this study is to prove the variation of immune cell activity between preoperative and postoperative period.

The patients were allocated randomly to receive propofol or sevoflurane. Also, a total of 18ml of blood sample was obtained for total 3 times in consecutive order.

1. immediate before anesthesia induction
2. postoperative 1 hours
3. postoperative 24 hours

Serum in blood will be obtained and activity of helper T cell, natural killer cell and level of serum cytokine will be evaluated by flow cytometry or enzyme-linked immunosorbent assay

Eligibility Criteria:
Inclusion Criteria:

* patient who was planned to undergo colon cancer surgery.

Exclusion Criteria:

* age \< 20 years old
* history of hypersensitivity reaction in propofol or sevoflurane
* history of previous cancer
* patient with ongoing inflammation
Helping Hospitalized Patients Quit Smoking

The study is being done to determine whether an in-hospital intervention using a brief intervention to facilitate quitline utilization will increase quitline utilization by hospitalized smokers, and will increase post hospital discharge smoking abstinence rates.

Study participants will be randomized to receive either a brief quitline facilitation intervention , or a control intervention of a brief stop-smoking message.

The study will also compare healthcare costs and utilization in the first six months following hospitalization between the two groups.


Eligibility Criteria:
Inclusion Criteria:

Current smoker, Resident of Olmsted County, Inpatient admission to St. Marys or Rochester Methodist Hospital, Able to participate fully in all study aspects, Available for follow-up

Exclusion Criteria:

Current active treatment for tobacco use initiated prior to hospitalization
Extension Study Following the Studies MT-1186-A03 or A04 to Evaluate the Safety of Oral Edaravone in Subjects With ALS

The purpose of this study is to evaluate the safety of oral edaravone at a dose of 105 mg administered once daily for 10 days out of a 14-day period, followed by a 14-day drug-free period. This study will be continued until the earlier date when oral edaravone is commercially available at each site in Japan or August 2023.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must provide a signed and dated informed consent form (ICF) to participate in the study.
* Subjects must be able (in the judgment of the Investigator) to understand the nature of the study and all risks involved with participation in the study
* Subjects must be willing to cooperate and comply with all protocol restrictions and requirements.
* Subjects who successfully complete Week 96 of Study MT-1186-A03 or Week 48 of Study MT-1186-A04 and have been compliant with study drug (80-120%).

Exclusion Criteria:

* Subjects of childbearing potential unwilling to use a highly effective method of contraception from the Visit #1 until 3 months after the last dose of study medication.
* Subjects who have a significant risk of suicide. Subjects with any suicidal behavior or suicidal ideation of type 4 (active suicidal ideation with some intent to act, without a specific plan) or type 5 (active suicidal ideation with specific plan and intent) based on the C-SSRS at Week 96 of the A03 study or at Week 48 of the A04 study.
* Subjects who are not eligible to continue in the study, as judged by the Investigator.
Questionnaires Assessing the Quality of Life of Patients Treated for Coronary Heart Disease

Cardiovascular disease remains the leading cause of death in Europe and worldwide. In 2014, they led to more than 4 million deaths in Europe, and coronary heart disease alone accounts for nearly 1.8 million deaths, or 20% of all deaths in Europe. However, mortality from cardiovascular disease and, especially, coronary heart disease has declined in recent decades. This has been made possible by improving the quality of care provided to patients. Several studies have been conducted to demonstrate this improvement in the quality of care, but they mainly measure the functional results of treatment, morbidity and mortality, survival and prolongation of life.

However, patient-centered outcomes such as health-related quality of life outcomes (such as mental function, ability to resume activities of daily living, social relationship) are also considered important outcomes in the management and monitoring of these diseases. Some studies have shown that, even when other risks factors are controlled, a poor quality of life related to health is a prediction factor for morbidity and mortality in patients with coronary artery disease.

Some studies have suggested that health-related quality of life should be strongly associated with lifestyle, co-morbidities, and mental function.

Some factors have been identified as factors that may affect the quality of life in patients with coronary artery disease, including depression, anxiety, dyspnea and angina pectoris. Depression and anxiety were negatively associated with health-related quality of life in patients with cardiovascular disease. As for dyspnea, it has been shown that in stable patients who have had a myocardial infarction, its increase at 1 month after initiation of treatment is strongly associated with a decrease in the quality of life and with an increased risk of re-hospitalization and death. It is therefore important to measure these factors when the quality of life is assessed in patients with coronary heart disease.

The importance of assessing quality of life is that the clinician and the patient often have different concerns: what the clinician considers to be a "successful procedure" is not always considered as such by the patient. Results related to quality of life (results rarely evaluated) are among the results that really interest the patient. Indeed, many patients consider the quality of additional years of life acquired as important as the lifespan, so the goal of today's medicine is to improve the quantity and quality of life of the additional years of life acquired. To ensure this improvement, the assessment of health-related quality of life should be integrated into the daily clinical practice of coronary heart disease management.

The objective of our study is to evaluate the feasibility of this practice throughout the traject of care, by using several standardized questionnaires.


Eligibility Criteria:
Inclusion Criteria:

Confirmed coronary disease

Exclusion Criteria:

Emergencies, patients lost to follow-up.
Effects of Septorhinoplasty on Allergic Rhinitis

Allergic rhinitis (AR) is a chronic inflammatory disease that affects almost 30% of adult population. Some patients associate septal deviation, main cause of chronic nasal obstruction, and AR. Current literature about AR treatment with septoplasty (STP) is still contradictory, because is thought that patients with AR are not able to appreciate improvement after surgery.

Patients diagnosed with allergic rinitis and septal deviation were evaluated to determined life quality and airflow obstruction evolution after STP.

This is a prospective quasi experimental study. After being informed about the study, patients that signed written informed consent were included in the study. In week 0 before surgery, all measurements and questionnaires were performed. 1 month after surgery, measurements were repeated.

After screening, patient´s obstruction was evaluated by anterior rhinomanometry (RNMa), and quality of life scored through ESPRINT scale. ESPRINT is a validated Spanish questionnaire about daily life activity, sleep, psycology and perception of affection by allergic rhinitis. Symtoms were evaluated with visual analogue scale (VAS) and clinical history. Symptoms like sneezing, itchy nose, ocular symptoms and/or nasal obstruction. Also medication (intranasal corticosteroid, antileucotrienos, antihistamines eye drops , antishistamines) frequency use was registered.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Allergic Rhinitis
* Diagnosis of nasal obstruction with septal deviation

Exclusion Criteria:

* Previous nasal surgery
* Smokers
* Chronic obstructive pulmonary disease
* Psychiatric disorders
* Malignant tumors
* Severe hepatopathy
* Obstructive sleep apnea
Longitudinal Assessment of Traumatic Microvascular Injury-2

The goal of this observational study is to learn about changes in the brain of patients over the first 3 years following a traumatic brain injury (TBI). The main question it aims to answer are:

- How TBI effect the rate of brain tissue loss compare to healthy brain

Participants will give blood samples, complete MRI scans, and neuropsychological assessment measures.

Researchers will compare results between healthy control group and TBI group to determine changes in injured brains.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18-65, inclusive
2. History of non-penetrating TBI of at least moderate severity (defined by evidence of trauma-related neuroimaging abnormality on cranial computerized tomography (CT) scan.
3. High-velocity, high-impact injury mechanism consistent with diffuse axonal injury (e.g., motor vehicle accident, fall from height, etc.)
4. Immediate loss of consciousness (cases with delayed loss of consciousness due to expanding lesions will be excluded)

Exclusion Criteria:

1. History of premorbid disabling neurological or psychiatric disease (such as epilepsy, brain tumors, meningitis, cerebral palsy, encephalitis, brain abscesses, vascular malformations, cerebrovascular disease, Alzheimer's disease, multiple sclerosis, HIV-encephalitis)
2. History of premorbid disability condition that would interfere with outcome assessments
3. Bilaterally absent pupillary Reponses
4. Penetrating TBI
5. Elevated intracranial pressure (≥ 17 mmHg) 6 Contradictions to contrast-enhanced MRI (e.g., ferromagnetic implants, pregnancy, allergy to gadolinium contrast, renal impairment \[GFR \< 60ml/g/m3\], claustrophobia, hemodynamic instability)

7. Prisoners, patients in police custody 8. Objective lung disease (PaCO2 at rest \> 50 mmHg or venous serum bicarbonate \> 26 mEg/L) based on any labs available for review from patient's clinical care. Note that these will not be checked solely for study purposes 9.Requiring portable oxygen at enrollment 10. Chronic heart failure, severe pulmonary disease 11. Current substance abuse that precludes participation and follow-up in the study, as determined by the study investigators 12. If there is medical or other disability that precludes completion of the study procedures as determined by the study investigators
Advancing People of Color in Clinical Trials Now: Involvement in Trials Using a Patient-Centered Website: A Community-Engaged Approach

The purpose pf this study is to evaluate the comparative effectiveness of a culturally and linguistically tailored clinical trial literacy website in increasing likelihood of participating in clinical trials. To achieve this objective,a randomized group design will address the following patient-centered outcomes: willingness to enroll in clinical trials and behavioral intent as well as likelihood of referring others to enroll in such trials) before and after exposure to a culturally-tailored clinical trial literacy website. Health literacy will be measured both before and post exposure to tailored messages. Participants will be randomized into two groups. The intervention group (n=50) will have access to culturally tailored website. Participants in the control group (n=50) will have access to NYU 's standard trial participation website.

Compelling evidence demonstrates racial/ethnic disparities in health and healthcare in the United States. These disparities arise from various factors including unequal access to adequate medical care, perceived racial discrimination, and poor health literacy.The Center for Healthful Behavior Change (CHBC) has been involved in numerous initiatives to eradicate health disparities and have implemented NIH-funded interventions to address inequities in health. Interventions targeting patient-centered outcomes have been suboptimal because of inadequate infrastructure to support equitable contributions from stakeholders (patients, providers, and community leaders) in all aspects of the research process. This is crucial to promote sustainable effects regarding minority patients' ability to make informed decisions about participating in existing clinical trials. This study will address this gap, bringing together academic investigators and important stakeholders to develop a website providing access to culturally tailored videos to enhance awareness of clinical trial, health literacy, thus promoting participation in existing clinical trials.

Eligibility Criteria:
Inclusion Criteria:

* Self-reported race/ethnicity as African American, African, Caribbean American or black men and women
* accessible by telephone
* no plans to move away from the region within the year following enrollment; consent to participate.

Exclusion Criteria:

* Progressive medical illness in which disability or death is expected within one year
* impaired cognitive or functional ability, which would preclude meaningful participation in the study
* stated intention to move within the same year of enrollment.
A 12 Day Study To Evaluate A Topical Drug To Treat Plaque Psoriasis

This is a vehicle and comparator controlled Proof of Mechanism (PoM) trial to evaluate the effect on psoriasis disease activity and safety of topically applied PF 06263276 in subjects with psoriasis vulgaris.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and/or female subjects age 18 years and older, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG or clinical laboratory tests.
* Subjects with psoriasis vulgaris in a chronic stable phase and with a plaque area of mild to moderate severity sufficient for six treatment fields located in up to three plaque areas.
* The target lesion(s) should be on the trunk or extremities (excluding palms/soles). Psoriatic lesions on the knees or elbows are not to be used as a target lesion.

Exclusion Criteria:

* Subjects with psoriasis guttata, psoriasis punctata, psoriasis erythrodermatica, psoriasis arthropathica and pustular psoriasis.
* Treatment with any systemic medications which in the opinion of the investigator might counter or influence the trial aim (including anti psoriasis medications, eg, corticosteroids, cytostatics or retinoids) or medications which are known to provoke or aggravate psoriasis (eg, beta blocker, anti malarial drugs, lithium) or phototherapy/psoralen+UVA (PUVA) within 4 weeks preceding the treatment phase of the trial and during the trial.
* Treatment with any locally acting medications (including anti-psoriasis medications like vitamin D analogues, dithranol) within 4 weeks of the treatment phase.
Performance Evaluation of Contact Lenses Among a Population of Adapted Contact Lens Wearers

This study is being conducted to evaluate Bausch \& Lomb PureVision Multi-Focal contact lenses compared to the Bausch \& Lomb SofLens59 contact lens when worn by adapted soft contact lens wearers on a daily wear basis.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must have clear central corneas and be free of any anterior segment disorders.
* Subjects must be adapted soft contact lens wearers and agree to wear the study lenses on a daily wear basis for at least eight hours a day for approximately two weeks.
* Subjects must wear a lens in each eye and each lens must be of the same manufacture and brand.

Exclusion Criteria:

* Subjects participating in any drug or device clinical investigation within two weeks prior to entry into this study and/or during the period of study participation.
* Subjects with any systemic disease affecting ocular health
* Subjects with an active ocular disease or using any ocular medication.
* Subjects who have had any corneal surgery (eg, refractive surgery).