cyrilzakka/clinical-trials huggingface dataset:
Cardiac Energetics and Function in Normal Human Ageing

Normal aging is characterized by altered cardiovascular function. Our preliminary data with MR imaging and spectroscopy in normal subjects without cardiovascular disease or hypertension show that age-related cardiac dysfunction is characterized initially by impaired relaxation of the heart (40 - 60 years), and then at \> 60 years altered contraction and impaired myocardial energetics. For the first time, the investigators will test whether the functional and energetic effects of normal aging can be reversed by acutely reducing stiffness of peripheral blood vessels using an ACE inhibitor. This will potentially have important insights into how normal aging affects the heart, and how potential treatments could be used to attenuate this process.

Normal aging is characterized by altered cardiovascular function. Our preliminary data with MR imaging and spectroscopy in normal subjects without cardiovascular disease or hypertension show that age-related cardiac dysfunction is characterized initially by diastolic dysfunction (40 - 60 years), and then at \> 60 years altered systolic strains and impaired myocardial energetics. The investigators propose to study the mechanism of these findings in subjects with normal aging without any cardiovascular disease, hypothesizing that increased vascular stiffening contributes to impaired energetics and left ventricular function. For the first time, the investigators will test whether the functional and energetic effects of normal aging can be reversed by acutely reducing afterload using an ACE inhibitor. This will be tested at 2 ages (40-60 and \> 60 years), so that the intervention tests the hypothesis soon after the abnormalities develop (40-60 years - diastolic dysfunction; \> 60 years energetics and altered strains). This will potentially have important insights into how normal aging affects the heart, and how potential treatments could be used to attenuate this process.

Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects between the ages of 20 and 80 years

Exclusion Criteria:

* Any cardiovascular condition including hypertension, or on any cardiovascular therapy.
* Blood Pressure \> 150 mmHg systolic, and/or \> 90 mmHg diastolic
* Claustrophobia
* Implanted metal prosthesis
* Chronic renal failure requiring dialysis
* Diabetes mellitus.
Controlling Myopia Progression With Soft Contact Lenses

This study is to investigate whether novel soft contact lens optical designs can slow myopia progression.

The study will be a prospective, randomized, single blind, bilateral dispensing study

Eligibility Criteria:
Inclusion Criteria:

1. Myopic subjects between 8 and 12 years of age.
2. The subject best sphere contact lens correction must lie between -0.75D (best of the two eyes) and -5.00D (worst of the two eyes)
3. Astigmatism must be less than or equal to 1.00D
4. 1.00D or less difference in spherical equivalent between the two eyes
5. The subject must have a best-corrected visual acuity of 0.8+2 (20/25+2) and spherical equivalent refraction visual acuity of 0.820/25) or better in both eyes
6. The subject must have at least 8D of accommodation
7. The subject and subject's parent or legal guardian must read and sign the STAEMENT OF INFORMED CONSENT
8. The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.

Exclusion Criteria:

1. Any ocular or systemic allergies or diseases that may interfere with contact lens wear.
2. Systemic disease or autoimmune disease or use of medication (e.g. antihistamine), which may interfere with lens wear.
3. Clinically significant (grade 3 or 4)corneal edema, corneal vascularization, corneal staining, or any other abnormality of the cornea, which may contraindicate contact lens wear.
4. Clinically significant (grade 3 or 4) tarsal abnormalities or bulbar injection that might interfere with contact lens wear.
5. Any ocular infection.
6. Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
7. Any infectious disease (e.g., hepatitis, tuberculosis) or an immunosuppressive disease (e.g. HIV)
8. Diabetes
9. Anisometropia of greater than 1.00D
10. Astigmatism of greater than 1.00D in either eye
11. Eye injury or surgery within eight weeks immediately prior to enrollment for this study.
12. Pervious refractive surgery, rigi contact lens wear, orthokeratology, keratconus or other corneal irregularity in either eye.
13. Strabismus in either eye
14. Pupil orr lid abnormality or infection in either eye
15. Central corneal scar in either eye
16. Aphakia in either eye
17. Contraindications to contact lens wear such as dry eye or history of prior unsuccessful contact lens wear.
18. History of participation in prior clinical trials aimed to control myopia progression
19. Surgically altered eyes, ocular infection of any type, ocular inflammation
20. Subject has anterior chamber angle grade 2 or narrower
US National OCS Liver Perfusion (OLP) Registry

This Registry is a sponsor-initiated, multi-center, observational, post-approval registry with an independent academic oversight.

TransMedics has contracted with United Network for Organ Sharing (UNOS) the Federal manager of the U.S. national transplant outcomes registry to obtain data that is routinely collected by the Organ Procurement and Transplantation Network (OPTN) on all transplanted organs in the U.S. for both the OCS liver transplanted patients as well as patients transplanted using other preservation modalities. Additional data will be collected by participating centers using OCS Liver perfusion.


Eligibility Criteria:
All liver transplant recipients.
Heart Health NOW (Previously Known as FAST PACE NC)

The objective of this study is to determine if primary care practice support accelerates the dissemination and implementation of patient-centered outcome results (PCOR) findings to improve heart health and increases primary care practices' capacity to incorporate other PCOR findings in the future.

The burden of cardiovascular disease in North Carolina remains large. The latest data available show an annual cardiovascular death rate of 263 per 100,000 explaining almost one-third of deaths in the state. Disease progression is largely determined by several risk factors including elevated blood pressure or cholesterol, not using aspirin for prevention, and tobacco use. Primary care practices as currently organized have been unable to get more than half these patients to achieve recommended targets for risk factor reduction. Small independent practices, in particular, lack resources for enhanced practice support to improve cardiovascular care.

This study will enroll 300 primary care practices to evaluate the effect of primary care support on evidence-based cardiovascular disease (CVD) prevention and organizational change process measures. Each practice will start the trial as a control, receive the intervention at a randomized time point, and then enter a maintenance period 12 months after starting the intervention. All practices will receive 12 months of the intense intervention including onsite quality improvement (QI) facilitation, academic detailing, electronic health record (EHR) support, and, through the North Carolina Health Information Exchange (HIE), a shared statewide utility providing whole population analytics, care gap identification, benchmarking, and an external reporting mechanism which otherwise would not be available to independent practices.

A successful intervention would prove that practice facilitation supported by effective informatics tools is an effective method of translating PCOR findings into practice. Discernible reductions in cardiovascular risk in 300 practices covering over an estimated 900,000 adult patients would likely lead to prevention of thousands of cardiovascular events within 10 years.

Eligibility Criteria:
Inclusion Criteria:

* Primary care practice in North Carolina with 10 or fewer providers in a single location
* must have implemented an EHR and either be connected to or have agreed to connect to the HIE.

Exclusion Criteria:

* practices with more than 10 providers in a single location
* practices receiving practice facilitation services beyond the usual support provided by Area Health Education Centers (AHEC) or the Community Care of North Carolina (CCNC) program through their parent organization.
* practices without an EHR
* practices where the central practice organization either bars the practice from our program or provides onsite facilitation services equal to or greater than the 4-6 hour standard contact with a QI coach
Effects of the Soluble Mediators of Mastocytes on the Intestinal Epithelial Barrier and of the Enteric Nervous System During the Syndrome of the Irritable Bowel

Patients with irritable bowel syndrome (IBS) have increased intestinal permeability. In addition, mucosal soluble mediators are involved in the pathophysiology of pain in IBS. The investigators aimed to investigate:

1. paracellular permeability in colonic biopsies of IBS patient
2. the ability of soluble factors from colonic biopsies to reproduce in vitro these alterations


Eligibility Criteria:
Inclusion Criteria:

* Patients needing coloscopy

Exclusion Criteria:

* Disrupted coagulation results
* Cancer even healed
* Known food allergy.
* Alcohol consumption \>30g/day
Effects of Nitrous Oxide: A Dose-Response Analysis - 5

The purpose of this study is to conduct experiments to examine subjective and reinforcing effects of nitrous oxide. Mood altering and psychomotor effects will be tested on non-drug abusers and preference procedures will be used to assess reinforcing effects. To examine the subjective, psychomotor, and reinforcing effects of nitrous oxide in healthy volunteers. This is a dose-response analysis.


Eligibility Criteria:
Please contact site for information.
YUKON Choice Versus TAXUS Liberté in Diabetes Mellitus

Revascularisation procedures such as percutaneous coronary intervention are associated with overall worse outcomes in patients with diabetes mellitus. Implantation of coronary stents is associated with higher restenosis rates compared to non-diabetic individuals.

There is only limited data available on the efficacy and safety of the novel Yukon Choice drug-eluting stent system specifically in patients with diabetes mellitus. The trial will determine the efficacy and safety of the novel Yukon Choice stent system compared to the well established Taxus Liberté stent system. The primary endpoint will be "in-stent late lumen loss" at 9 months as determined by invasive angiography.


Eligibility Criteria:
Inclusion Criteria:

* age \> 18 years
* diabetes mellitus
* symptoms (stable or unstable angina pectoris) or objective evidence of myocardial ischemia
* one or more de novo lesions in 1, 2 or 3 native coronary arteries
* clinically significant diameter of stenosis (50-99 % according to visual assessment of operator)
* lesion must be covered by stent length of no more than 24 mm and stent diameter of no more than 3,5 mm
* vessel diameter of no more than 4 mm in vessel area adjacent to stenosis
* informed consent

Exclusion Criteria:

* unprotected left main disease
* complete occlusion of target vessel
* in-stent-restenosis
* stenoses of bypass grafts
* indication for bypass surgery
* bifurcation lesions (side branch \> 2,0 mm)
* thrombus in target lesion as visualized by angiography
* allergy or contraindication to concomitant medication (clopidogrel, aspirin, heparin, contrast media)
* acute myocardial infarction within preceding 48h
* participation in another trial
* pregnancy
* severe disorder of coagulation or platelet function
Effects of Empagliflozin on Cardiac Microvasculature and Insulin Sensitivity in Subjects With Type 2 Diabetes

The aim is to test in T2DM patients, whether, compared to placebo, 12 weeks of SGLT-2 inhibitor improves post-absorptive, post-insulin infusion or postprandial insulin action to enhance Cardiac Muscle vascular function and whether changes correlate with improved GV or postprandial hyperglycemia

The investigators will study 32 T2DM subjects measuring cardiac muscle vascular function before and after a 4 hour insulin clamp ( protocol A) and before and after a mixed meal (protocol B). Then subjects will be randomized into 2 groups: Group 1 will undergo a 12 week intervention of Empagliflozin, and Group 2 will do 12 weeks of Placebo. The intervention will be single blinded. At the end of the 12 week intervention subjects will repeat protocol A and B.

The study's primary objective is to assess whether, compared to placebo, 12 weeks of Empagliflozin improves post-absorptive or postprandial insulin action to enhance myocardial perfusion (MP) and whether changes of MP correlate with improved glucose variability or postprandial hyperglycemia

Eligibility Criteria:
Inclusion Criteria:

* A1C \> 6.5 and \<9%
* Never on SGLT-2i (eg: Jardiance, Invokana, Farxiga, Steglatro)
* On stable dose of oral hypoglycemic agents \>3 months
* On stable dose of other medications for \>3 months
* BMI-\<35

Exclusion Criteria:

* • Smoking presently or in the past 6 months

  * Taking insulin
  * BP \>160/90
  * BMI \>35
  * History of congestive heart failure, ischemic heart disease, severe pulmonary disease, liver or kidney disease.
  * Any vascular disease such as myocardial infarction, stroke, peripheral vascular disease
  * History of cancer or psychiatric disease
  * Presence of an intracardiac or intrapulmonary shunt (we will screen for this by auscultation during the physical exam by PI).
  * Pregnant or breastfeeding.
  * Known hypersensitivity to perflutren (contained in Definity)
  * Screening O2 saturation \<90%
  * History of recurrent UTI/bladder/kidney infections-eGFR is below 45 mL/min/1.73.
Feasibility of Combined Genomics/Transcriptomics for Patients With Lymphoma

To learn more about the usefulness of molecular testing with the Molecular Functional (MF) Portrait (a commercial test conducted by the sponsor of this study, BostonGene) in guiding lymphoma care.

Primary Objective:

• To determine the feasibility and turnaround of clinical WES and transcriptome sequencing

Secondary Objectives:

* To determine the frequency of actionable DNA and RNA alterations
* To determine the concordance of DNA and RNA alterations
* To determine the frequency of molecularly matched therapy
* To determine the feasibility of identifying mechanism(s) of acquired resistance with genomic profiling
* To determine the feasibility of molecularly matched therapy to acquired resistance alterations

Exploratory Objectives:

* To determine the feasibility of prioritizing targets with precision analytics
* To determine clinical outcomes in patients receiving molecularly matched therapy
* To determine the role of additional emerging diagnostic technologies

Eligibility Criteria:
Patient Eligibility:

Inclusion Criteria:

1. Male/female patients who are at least 18 years of age on the day of informed consent signing.
2. Patients must have a histologically documented diffuse large B-cell lymphoma requiring therapy.
3. Provision of written informed consent for the study.

Exclusion Criteria:

1. None
The Effect Of Antenatal Corticosteroids On Early And Late Perinatal Outcomes

In this study, the investigators aims to evaluate whether antenatal corticosteroid administration to women likely to give birth in the late preterm period will reduce early and late neonatal complications and contribute to the literature in this sense.

This study is a single-center prospective case-control study investigating the effect of antenatal corticosteroids administered in the late preterm period on early and late perinatal outcomes. 459 patients who gave birth between 34-37 weeks between June 1,2021 to October 1,2022 in the Obstetrics and Gynecology Clinic of the University of Health Sciences were included. Patient were divided into two groups antenatal corticosteroid administration (n:231) and non-administration (n:228). Postpartum early and late perinatal outcomes were compared between these two groups.

Eligibility Criteria:
Inclusion Criteria:

* All pregnant women who had normal vaginal delivery, cesarean section or operative delivery between 34-37 weeks
* Singleton pregnancies resulting in a live birth

Exclusion Criteria:

* Twin pregnancies
* All births before 34 weeks or after 37 weeks
* Pregnant women with intrauterine ex fetus
* Fetuses with major congenital and chromosomal abnormalities
* Pregnant women who administrated antenatal corticosteroids for any reason before 34 weeks
A Universal Medication Schedule to Promote Adherence to Complex Drug Regimens

This study will leverage available technologies and test strategies to impart the Universal Medication Schedule (UMS) in primary care to help patients understand, consolidate, safely use, and adhere to their complex medication regimens.

The study investigators will conduct a patient-randomized controlled trial using a 2x2 factorial design to compare the effectiveness of interventions, alone or in combination, to one another. 1505 English and Spanish-speaking patients who are ≥ 50 years old, from a federally qualified health center (FQHC) in Chicago, and prescribed ≥ 3 Rx medications will be randomized to receive: 1) Enhanced Usual Care (EHR tools), 2) EHR tools + SMS, 3) EHR + Portal, or 4) EHR + SMS + Portal.

The study aims to:

1. Compare the effectiveness of the UMS EHR tools, with or without SMS and/or Portal interventions.
2. Evaluate the 'fidelity' (reliability) of each strategy and explore patient, staff, physician, and health system factors influencing the delivery of the interventions, alone and in combination
3. Assess the costs required to deliver each of the interventions from a health system perspective

Due to an NIA administrative hold, the interventions were not implemented as planned. Hence it was determined that the primary analysis would be "per-protocol" rather than intent-to-treat to assess the effect of the interventions under optimal conditions. Participants who either received the initial 6 weeks of SMS messaging continuously, or logged on to the patient portal and completed at least one survey will be considered as receiving the intervention. Those who have not received the initial 6 weeks of texting or completed at least 1 portal survey will be considered as enhanced usual care.

Eligibility Criteria:
Inclusion Criteria:

* age 50+
* English or Spanish speaking
* Prescribed 3+ medications
* Primarily responsible for administering own medication
* Owns a cell phone and feels comfortable receiving texts
* Access and proficient in using internet at home and has a personal email address

Exclusion Criteria:

* Major cognitive, visual, or hearing impairment
* Doesn't meet inclusion criteria.
COVID-19 Vaccine Boosters in Patients With CKD

This study is a 12-month, four-arm parallel-group randomized control trial of Pfizer-BioNTech versus MODERNA COVID-19 (Corona Virus disease 2019)vaccine boosters in chronic kidney disease and dialysis patients with poor humoral response following COVID-19 vaccination, in collaboration with 5 dialysis centers in Ontario and British Columbia, Canada .

Patients will be randomized to MODERNA or Pfizer-BioNTech COVID-19 vaccine, they may have received either MODERNA or Pfizer-BioNTech COVID-19 vaccine for their initial two doses of vaccine, and will be stratified by their initial vaccine type (MODERNA or Pfizer-BioNTech ) prior to randomization, which will result in four study groups.

MODERNA : Nucleocapsid Modified messenger RNA BioNTech: Bio-Pharma new Technology

Eligibility Criteria:
Inclusion Criteria:

* Patients with Chronic Kidney Disease (CKD)stage 3b-5 defined as an eGFR( estimated glomerular filtration rate ) of less than 45ml/min/1.73m2 or less will be eligible. Stage 5 CKD will include patients receiving in-center hemodialysis, home dialysis (home hemodialysis or peritoneal dialysis), vaccinated with two doses of the COVID-19 vaccine will be eligible for a third dose to be given 2-12 months following the second dose.
* Age ≥18 at the time of study enrolment

Exclusion Criteria:

* Patients not vaccinated against COVID-19 vaccination.
* Patients who received heterologous first two doses of vaccine
* Patients with a severe allergic reaction to prior COVID-19 vaccination or any of the ingredients.
* New COVID-19 infection
Bimatoprost Ophthalmic Solution in Increasing Eyebrow and Eyelash Growth in Patients Who Have Undergone Chemotherapy for Breast Cancer and in Healthy Participants

RATIONALE: Bimatoprost ophthalmic solution may help increase eyebrow and eyelash growth in patients who have undergone chemotherapy.

PURPOSE: This randomized clinical trial is studying how wells bimatoprost ophthalmic solution works in increasing eyebrow and eyelash growth in patients who have undergone chemotherapy for breast cancer and in healthy participants.

OBJECTIVES:

Primary

* To assess the effectiveness of bimatoprost ophthalmic solution in expediting regrowth of eyebrows and eyelashes in patients who have undergone chemotherapy for breast cancer and in increasing eyebrow growth in healthy participants with no known underlying disease as assessed by two physicians and an aesthetics expert on a scale of 0-4.

Secondary

* To assess the effectiveness of this treatment as assessed by patient self-report on a scale of 0-4.
* To assess the psychological impact of this treatment as assessed by patient-completed questionnaires.

OUTLINE: Patients are randomized to 1 of 2 intervention arms.

* Arm I: Patients apply topical bimatoprost ophthalmic solution to base of upper eyelid margins OR to eyebrow region once daily for 4 months in the absence of unacceptable toxicity.
* Arm II: Patients apply topical placebo solution to base of upper eyelid margins OR to eyebrow region once daily for 4 months in the absence of unacceptable toxicity.

Patients complete questionnaires at baseline and monthly for 5 months about changes in eyebrows/eyelashes, side effects of treatment, and the psychological impact of treatment. Photographs of eyebrows or eyelashes and surrounding skin are taken at baseline and monthly for 5 months and reviewed by a physician and aesthetics expert.

After completion of study treatment, patients are followed up at 1 month.

Eligibility Criteria:
Inclusion Criteria:

* Meets 1 of the following criteria:
* Diagnosis of breast cancer (group 1)
* Completed chemotherapy within the past month that has resulted in eyebrow alopecia or eyelash hypotrichosis
* Eyebrow score of 0-2 or eyelash score of 0-2 on the study's qualitative eyebrow or eyelash growth chart
* Has no known underlying disease (group 2)
* Desires thicker, fuller, or more numerous eyebrows

Exclusion criteria

* pregnant
* does not Speak a language adequately covered by study translator services
* cognitive impairment
* history of trauma or burn to the eyebrow region, alopecia areata, or trichotillomania
* known diagnoses possibly underlying or contributing to the state of the eyebrows including, but not limited to, telogen effluvium or anagen effluvium (group 2)
* active ocular disease (group 1)
* thyroid hormone level abnormalities (group 2)
* More than 2 years since prior ocular surgery (group 1)
* prior topical medication for increasing eyebrow growth within 30 days od starting study treatment
* concomitant chemotherapy for the treatment of cancer (group 1)
* concomitant therapy for eyelash or eyebrow growth