cyrilzakka/clinical-trials huggingface dataset:
OCS™ Lung TOP Registry For Donor Lungs for Transplantation

Single-arm, prospective, multi-center, post-approval U.S. registry

This is an all-comers registry that will enroll:

1. Patients who receive OCS™ preserved double lung transplants from either standard criteria donors or donors initially deemed unacceptable; and
2. Patients who receive a single lung transplant from OCS™ preserved lung pairs from either standard criteria donors or donors initially deemed unacceptable; and
3. All donor lungs that were perfused on OCS Lung System.

Enrolled patients will fall into one of the following three possible analysis categories:

1. TOP SCDL PAS Primary Analysis Population: will be comprised of recipients transplanted with SCDL primary analysis population eligible donor lungs preserved on the OCS™ Lung System.
2. TOP DLIDU Primary Analysis Population: Will be comprised of recipients transplanted with DLIDU primary analysis population eligible donor lungs preserved on the OCS™ Lung System.
3. All Other Enrolled Patients: will be comprised of all OCS Lung transplanted patients in the TOP Registry that do not meet any of the above analysis populations.

Patient enrollment in the TOP Registry will continue until 266 eligible DLIDU Primary Analysis Population recipients have been enrolled.

Eligibility Criteria:
This is an all-comers registry that will enroll all:

* Patients who receive OCS™ preserved double lung transplants from either standard criteria donors or donors initially deemed unacceptable; and
* Patients who receive a single lung transplant from OCS™ preserved lung pairs from either standard criteria donors or donors initially deemed unacceptable; and
* All donor lungs that were perfused on OCS Lung System.

Enrolled patients will fall into one of the following three possible analysis categories:

* TOP SCDL PAS Primary Analysis Population: will be comprised of recipients transplanted with SCDL primary analysis population eligible donor lungs preserved on the OCS™ Lung System.
* TOP DLIDU Primary Analysis Population: Will be comprised of recipients transplanted with DLIDU primary analysis population eligible donor lungs preserved on the OCS™ Lung System.
* All Other Enrolled Patients: will be comprised of all OCS Lung transplanted patients in the TOP Registry that do not meet any of the above analysis populations.
Diagnostic and Evaluation of Hepato-pancreatico-biliary Disease With MRI

This is a retrospective review of images from patient data. There is no recruitment necessary for this study.

Research Question: Can advanced multiparametric MRI techniques improve the detection and characterization of focal and diffuse liver disease, accurately assess treatment response and predict patient outcomes based on longitudinal monitoring? Hypotheses: Advanced multiparametric MRI techniques improve the detection, characterization and response assessment of focal and diffuse liver disease and can predict serious liver related outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Patients with suspicion for or diagnosed focal and/or diffuse liver or pancreatic disease who underwent MRI of the abdomen.
* 18 years of age and older.

Exclusion Criteria:

* Age less than 18 years.
* Lack of MRI of the abdomen.
* Inadequate image quality.
* Documented rejection to participate in research studies
Sports, Education and Consumption of Substances in Adolescents

Adolescent substance abuse (SA), which includes the consumption of alcohol, cigarette smoking, the consumption of drugs and other behaviors, is a significant public-health issue in the world today. Recent data showed that prevalence of SA among adolescents in Croatia and surrounding countries (i.e. former Yugoslav republics) is alarming and needs serious intervention. It is hypothesized that participation in physical-exercise-and-sport (PE\&S) will reduce the tendency of young people to abuse substances. However, the literature to date has not consistently validated the perception PE\&S factors are factors which could buffer SA among children and adolescents. One of the probable reasons for evident inconsistencies on findings about relationship between PE\&S and SA is a cross-sectional nature of studies done so far. Therefore, the main rationale (i.e. problem) of this study is lack of current knowledge about influence of the PE\&S on SA among adolescents. The main objective of this study is to prospectively investigate the influence of PE\&S on SA among adolescents aged 17 to 18 years old. Aims of the project are: (1) to define prevalence and trends of SA among adolescents aged 17 to 18 years old; (2) to define prevalence and trends of PE\&S participation; (3) to establish interrelationships which exist between socio-demographic, psychological, educational-factors, and PE\&S (predictors); (4) to identify multivariate and univariate associations between: socio-demographic and SA, psychological factors and SA, PE\&S and SA, educational - scholastic factors and SA.Expected results of the project are: (1) definition of the prevalence of SA among adolescents; (2) definition of the adolescents' participation in PE\&S; (3) identification and interpretation relationships which exist between and within studied predictors of SA (educational factors, socio-demographic factors, PE\&S, psychological factors); (4) identification of the influence of studied predictors on SA.


Eligibility Criteria:
Inclusion Criteria:

* Children involved in regular scholastic system

Exclusion Criteria:

* No
Development of an Active Video-Based High-Intensity Interval Exercise System in Children with Asthma

The aim of the study was to develop an active video-based high-intensity interval exercise system for the rehabilitation programs of children with asthma and to compare its immediate effects on heart rate variability, hemodynamic responses and thermal responses with a conventional high-intensity interval exercise.

The research consists of two main stages. For the first stage, an active video-based high-intensity interval exercise system will be developed. The game to be developed is considered as an entertaining supporter that adjusts the exercise intensity with the data by the heart rate sensor, warns with visual cues when the child needs to increase the exercise intensity, and keeps the child engaged in the exercise. The second stage is planned to compare the exercise system with the conventional high-intensity interval exercise method that has the same features.

The patient follow-up process will be monitored as; the patient who meets the inclusion and exclusion criteria will be directed by the physician, the patient and family consent will be obtained, pre-intervention evaluation, randomization, intervention, and post-intervention evaluation. The entire process will be carried out in one day.

The patients will be randomized into two groups: conventional high-intensity interval exercise and game-based high-intensity interval exercise, before the evaluation with the closed envelope method. Exercise will be applied at equal intensity (85% of the maximum heart rate) and duration for both groups, and the heart rate of the game-based group will be monitored with the sensor integrated into the game.

Eligibility Criteria:
Inclusion Criteria:

* Having asthma diagnosis according to GINA criteria
* Being between 8-15 years of age
* Having stabil asthma
* Coming to routine follow-ups regularly
* Being under regular pharmacological treatment and having good compliance with treatment confirmed by a physician
* Volunteering to participate in the study (both child and parent)

Exclusion Criteria:

* Having another diagnosed chronic disease other than asthma
* Obesity (Body mass index over 25
* Not having stable asthma defined as having had an exacerbation in the last 4 weeks
* Having severe persistent asthma
* Having exercise-induced asthma
* Not being able to complete the exercise capacity test
* Not being able to maintain the intensity of exercise ±5%
A Study of Ibandronate (Bonviva) in Patients With Post-Menopausal Osteoporosis

This study will evaluate participant-reported preference for either ibandronate or a comparator drug in women with postmenopausal osteoporosis. The anticipated time of study treatment is 6 months, and the target sample size is 338 individuals.


Eligibility Criteria:
Inclusion Criteria:

* Ambulatory women
* Diagnosis of post-menopausal osteoporosis
* Women who have never received bisphosphonate therapy, or who have discontinued daily bisphosphonates at least 3 months prior to study entry

Exclusion Criteria:

* Inability to stand or sit in the upright position for greater than or equal to 60 minutes
* Allergy to bisphosphonates;
* Previous or current treatment with weekly or monthly bisphosphonates, or daily bisphosphonates for the last 3 months prior to study entry
Capacity of Biofilm Removal and Gingival Abrasion After Utilization Medium and Soft Toothbrushes

This study compared the removal of dental biofilm between soft and medium toothbrushes. The patients refrained from performing mechanical or chemical plaque control for 96 hours to allow dental biofilm accumulation on the tooth surfaces. After the period of dental biofilm formation, the quadrants were randomized and the participants brushed different quadrants with soft and medium toothbrushes, with or without dentifrice. The plaque indices were analyzed by a blinded examiner before and after toothbrushing. The 2Tone was used for plaque disclosure and analysis was performed by the Quigley-Hein index modified by Turesky et al. (1970).


Eligibility Criteria:
Inclusion Criteria:

* The study was conducted on 25 participants selected among undergraduate dental students of UNIFRA (Santa Maria, Rio Grande do Sul, Brazil)
* Males and Females
* All systemically healthy
* Aged 18 to 30 years (mean age 21.4 ± 3.9 years) with at least 20 present teeth

Exclusion Criteria:

* The exclusion criteria comprised presence of sites with attachment loss ≥ 2mm
* Orthodontic appliances
* Prostheses
* Dental implants
* Aabrasions, restorations and/or carious lesions on the cervical region
Effect of Rosuvastatin on Left Ventricular Remodeling

The purpose of this study is to examine the the effect of the HMG-CoA reductase inhibitor Rosuvastatin on left ventricular remodeling in patients with dilated cardiomyopathy.

* Chronic heart failure (HF) is one of the most important public health problems in cardiovascular medicine.
* Idioatic dilated cardiomyopathy (CMP) represents the final common expression of primary myocardial damage produced by a variety of as yet undefined myocardial insults, producing areas of interstitial and perivascular fibrosis, particularly of the left ventricle. Chronic HF, including CMP, is a progressive disease with high morbidity and mortality, suggesting that important pathogenic mechanisms remain active and unmodified by the present treatment modalities. The presence of chronic inflammation in patients with chronic heart failure has been widely recognized and coupled with persistent immune activation may represent such unmodified mechanisms.

The effect of statin therapy on lipids are well known, but recent studies suggest that the beneficial effects of statins also may be related to their anti-inflammatory properties.

To further elucidate this issue we want to study the potent new statin Rosuvastatin on myocardial function and remodeling and their relation to inflammatory markers in patients with IDCM. As hyperlipidemia is not involved in the pathogenesis of IDCM, as opposed to HF secondary to CAD, such studies will also be an interesting approach in separating the lipid lowering from other effects of these medications in HF.

Eligibility Criteria:
Inclusion Criteria:

* Age of 18-80 years
* Have clinical or symptomatic evidence of HF, in NYHA class II-IV, for at least 3 months
* Have LVEF \<40%
* On optimal medical treatment and considered unsuitable for surgical intervention.
* Have given written informed consent
* No planned heart transplantation
* Female of potential childbearing age must have a negative serum pregnancy test within 7 days prior to enrollment. Effective contraception must be used during the trial and for 6 weeks following discontinuation of the study medication, even where there has been a history of infertility.

Exclusion Criteria:

* Evidence of unstable disease
* Evidence of ischemic etiology on the basis of history (diagnosed myocardial infarction), echocardiography or angiography)
* Evidence of clinical significant valvular disease based on echocardiography
* Significant concomitant diseases such as infections, pulmonary disease or connective tissue disease.
* Contraindication against statin therapy

  * Hypersensitivity against statins
  * Liver disease with SGOT and SGPT \> 2 timer upper normal limit
  * Baseline elevations of CK 3 times upper normal values at any time during the course of the study
  * Serum creatinine above 2.0 mg/dL (177 umol/L) at any time during the course of the study
  * Pregnancy or breast feeding
Study of Netarsudil Ophthalmic Solution in Subjects With Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT)

To evaluate the effect on trabecular outflow facility of Netarsudil ophthalmic solution 0.02% compared to placebo

Trabecular outflow facility is a measure of aqueous humor dynamics; effect of netarsudil on this parameter as well as on intraocular pressure and episcleral venous pressure was evaluated in this study. Netarsudil treatment was given in one eye and placebo given in contralateral eye for 7 consecutive days.

Eligibility Criteria:
Inclusion Criteria:

1. Must be 18 years of age or older
2. Diagnosis of open primary angle glaucoma(POAG) or ocular hypertension (OHT) in both eyes
3. Unmedicated intraocular pressure (IOP) \>20 mmHg and \< 30 mmHg in both eyes at first qualification visit
4. Best corrected visual acuity (BCVA) equivalent to 20/200 Snellen or better
5. Able to give informed consent and follow study instructions

Exclusion Criteria:

Ophthalmic:

1. Clinically significant ocular disease
2. Pseudoexfoliation or pigment dispersion component glaucoma, history of angle closure glaucoma, or narrow angles
3. Intraocular pressure ≥30 mmHg in either eye
4. A difference in IOP between eyes \>4mmHg at qualification visit
5. Use of more than two ocular hypotensive medications within 30 days of screening
6. Known hypersensitivity to any component of the formulation
7. Previous glaucoma surgery or refractive surgery
8. Keratorefractive surgery in either eye
9. Report of ocular injury in either eye within the six months prior to screening or ocular or non-refractive surgery within 3 months prior to screening
10. Recent or current ocular infection or inflammation in either eye
11. Use of ocular medication in either eye of any kind within 30 days of screening
12. Mean central corneal thickness greater than 620 μm in either eye
13. Any abnormality preventing reliable applanation tonometry of either eye
14. Lack of suitable episcleral vein prior to performing Episcleral Venus Pressure (EVP) measurement (applicable to 1 site only)

    Systemic:
15. Clinically significant abnormalities within 6 weeks prior to screening
16. Clinically significant systemic disease
17. Participation in any investigational study within 60 days prior to screening
18. Use of systemic medication that could have an effect on intraocular pressure within 30 days prior to screening
19. Women of childbearing potential who were pregnant, nursing, planning a pregnancy, or not using a medically acceptable form of birth control
Drug Interaction Study With NS2359 and Cocaine in Cocaine Experienced Volunteers - 1

The purpose of this study is to conduct a drug interaction study with NS2359 and cocaine in cocaine experienced volunteers.

This is a single-center, double-blind, placebo-controlled, randomized, single dose, fixed order, dose escalating inpatient design that will study oral NS2359 in cocaine experienced volunteers.

Eligibility Criteria:
Inclusion Criteria:

Male or Female, 18-45 yrs of age; females of child-bearing potential using appropriate method of birth control; be able to understand the procedure and agrees to participate via informed consent; must be cocaine dependent according to DSM-4 criteria; must be capable of providing written consent; must be able to comply with protocol requirement, CPU rules and regulations; must not be currently seeking treatment for cocaine abuse.

Exclusion Criteria:

Incapable of understanding the informed consent process; Additional criteria available during screening at the site.
Prevalence Study : Elderly Patients and Rehabilitation in ICU. Impact of Frailty.

Study design. The study FRAGIREA is a multicentric prevalence study on the frequency of frailty among elderly patients and the quality of management. The voluntary ICUs will have to include all patients ≥ 70 years on a limited period (1 month) or until the number of 15 inclusions is reached. The frailty is going to be evaluated by a frailty score adapted to the ICU, based on informations given by the patient's family.

It is a descriptive non-interventional study, aiming at the description of frequency of frailty and management of the patient in order to set-up a prospective future study on the potential role of early rehabilitation of ageing patients in ICUs.


Eligibility Criteria:
Inclusion Criteria:

* ≥ 70 year-old
* Prevision of a length of stay \> 24 hrs.
* Patient or relative who received information about the study and did not oppose it

Exclusion Criteria:

* Life expectancy \< 24 hrs
* Patients unable to communicate and no next of kin available.
* adults, non-emancipated minors, persons unable to receive information,
* persons placed under the safeguard of justice,
* subject participating in another search including an exclusion period still in progress at pre-inclusion
How Clinicians Manage Their Patients Who May Need Antithrombotic Care

This study aims to assess the knowledge and provide an opportunity for education to clinician attendees of the Canadian Cardiovascular Congress (CCC) meeting using a series of simulated patient case scenarios.

Health conditions requiring antithrombotic therapy are highly prevalent in Canada, contributing substantially to healthcare costs and patient quality of life. For example, over 60,000 Canadians will experience a heart attack per year.1 Alarming statistics such as this warrant appropriate treatment approaches from clinicians who specialize in cardiovascular conditions. The CCC is a national conference during which individuals with an interest or expertise in cardiovascular health from across the country attend. Leveraging this unique opportunity by implementing a simple educational endeavour during the 2023 event can provide instrumental insights on the most appropriate treatments recommended from the latest clinical practice guidelines to a wide set of practitioners; this could, in turn, potentially improve patient health outcomes.

This endeavour will take place at a set date from October 25th to 29th, 2023. Attendees of the CCC who approach a booth set up by the lead investigator of this project will be presented with the study letter of information and consent form on a tablet (i.e., an iPad). After providing an electronic informed consent to participate, a series of patient case scenarios that require antithrombotic care and therapy will be shown. For each case scenario, the attendee (now, considered a study participant) will be asked to indicate the treatment approach that he/she would choose. And finally, after reviewing all case scenarios and selecting the best treatment approach to his/her knowledge, the participant will be asked to provide an email address (which could be an anonymized one) to send the most appropriate treatment approaches for each case scenario. This last step allows the participant an educational opportunity to learn what the best practice approach is based on the most up-to-date clinical practice guidelines. The approximate total duration of the study is one-hour in total.

Eligibility Criteria:
Inclusion Criteria:

* Any clinician (i.e., licensed medical doctor, nurse practitioner) attending the CCC's 2023 event from October 25th-29th, 2023 will be included in this endeavour so long as they have the ability to provide informed consent (i.e., can read, write, and understand the English language).

Exclusion Criteria:

* None
RTL Concussion Communication

This study is aimed at improving health outcomes for adolescents who sustain sport and recreation related concussions (SRRC) by enhancing Return to Learn (RTL). The study will conduct a quasi-experimental school-based 2 phase study involving 200 students with SRRC. The first phase will be descriptive to evaluate current standards (n=50). Phase 2 will compare students whod receive either standard of care RTL (n=75) or RTL augmented by a communication tool (RTC+; n=75).

Up to 3.8 million secondary school students are diagnosed with a sport and recreation related concussion (SRRC) annually in the U.S., which can have a detrimental impact on educational attainment, a social determinant of health (SDOH) that is linked with college admission and graduation, employment, income status and social class. This research will address this significant public health problem by gaining a deeper understanding of the relationships among SRRC and SDOH and examine the impact of concussion management team communication on return to learn (RTL) outcomes for students following an SRRC. This research has significant potential to improve RTL outcomes of secondary school students and may provide evidence to support policy-level changes to reduce disparities in SRRC management, especially among low-resource school districts.

The three research aims of this study will proceed as follows:

Aim 1 will examine the relationships among SDOH, SRRC-related symptoms, and RTL milestones among a diverse population of adolescents and young adult secondary school students following SRRC. This aim will be achieved by enrolling and tracking secondary school students who sustain an SRRC over a 12-month period.

Aim 2 will compare RTL milestones among secondary school students following SRRC who are managed by an interdisciplinary concussion management team that uses standard or care plus a communication tool intervention or only standard of care for the RTL process.

Aim 3 will examine differential RTL outcomes between groups (standard of care plus a communication tool intervention vs. only standard of care) based on SDOH, sex as a biological variable, and pre-injury health status among secondary school students following SRRC.

The study aims to reduce disparities in timely management of SRRC during the process of RTL, achievement of RTL milestones and improvement of SRRC-related symptoms in the context of SDOH.

Eligibility Criteria:
Inclusion Criteria:

* Student: enrolled in Alachua County Public Secondary Schools who are age 14 or older and have sustained a new SRRC and voluntarily enrolled in the OSMI (Orthopaedic Sports Medicine Institute) concussion management program
* Parent: primary point of contact for the assenting student verified through the school

Exclusion Criteria:

* Student: Age 13 or younger, Not enrolled in Alachua County Public Schools, Did not sustain SRRC during school year
* Parent: not a verified point of contact for the assenting student