cyrilzakka/clinical-trials huggingface dataset:
Role of Circulating MicroRNAs in Pathogenesis of Aneurysms of the Abdominal and Thoracic Aorta - Study "Micro AAA"

The objective of this study is to establish whether patients with aortic aneurysm, compared to general population, have higher levels of selected miRNAs and whether there is significant association between the level of miRNA in circulating blood and the size of the aortic aneurysm or the risk of its rupture.

Aneurysm of the abdominal and thoracic aorta represents a major cause of cardiovascular morbidity and mortality. The course of this condition can stay asymptomatic for long, and its first manifestation can be acute rupture of the aneurysm sac with life-threatening bleeding. Detection of patients at risk and their early treatment significantly reduce the percentage of this potentially lethal complications.

Aortic diseases are most often degenerative processes with a varying involvement of genetic predisposition. In literature, a substantial number of genes were proved to affect the metabolism of the vessel wall and to determine production of structural proteins, which were associated with the vascular pathologies. Pathophysiologic mechanisms of lesions of the aortic wall have not been completely understood. Among other, they include endothelial dysfunction, chronic inflammation of the vessel wall, apoptosis of smooth muscle cells and degradation of the extracellular matrix, resulting in the loss of integrity of layers of the vessel wall and decrease in its strength, which leads to dilation, rupture or dissection. Apart from mutations in genes coding the structural proteins of the vessel wall, many other potential biomarkers were proposed for early diagnosis of aortic aneurysm. These include microRNA (miRNA), one-fibre chains of non-coding ribonucleic acid which are several nucleotides long and are involved in the gene expression through the mechanism of inhibition of mRNA translation or increase in its degradation. Recently, association of levels of these miRNAs to presence and growth of aortic aneurysms has been described.

Eligibility Criteria:
Inclusion Criteria:

study population:

* signed informed consent for participation to the study;
* age above 18 years;
* presence of untreated thoracic or abdominal aortic aneurysm (TAA or AAA);
* CT-verified diagnosis of AAA/TAA including measurement of the maximum diameter of the aneurysm.

control population:

* signed informed consent for participation in the study;
* age above 18 years;
* absence of a thoracic or abdominal aortic aneurysm (TAA or AAA).

Exclusion Criteria:

* life expectation above one year;
* history of myocardial infarction or unstable angina pectoris 1 month ago.
MRI Changes of Acute Kidney Injury in COVID-19

This is a prospective observational cohort study that will aim to recruit 60 participants who have had COVID-19, were admitted to hospital, required intensive care, and/or developed AKI during their hospital stay. Potential participants will be approached either by telephone by a member of the research team or via clinics (nephrology, post-ICU follow up clinics).

After the participants have read and understand the Participant Information Sheet, and had sufficient time (at least 24 hours) to consider their participation in this study, the investigators will ask them to sign a consent form, which shows their willingness to take part. The investigators will then collect information from their medical records about their hospital admission with COVID-19, including their age, ethnicity, medical conditions, length of hospital stay, tablets or any other treatments they received, as well as details of their stay in the ICU. The investigators will also arrange their first study visit which should be 3-6 months after they had been discharged from the hospital. During this first study day, the investigators will:

* Measure weight and height and take blood pressure.
* Take blood and urine samples.
* Ask participants to complete three questionnaires about their health, symptoms of fatigue and quality of life (SF-36, EQ-5D-5L and Fatigue Questionnaires).
* Measure the accumulation of toxins in the skin using a safe, quick (less than five minutes) and painless technique called skin autofluorescence. This involves placing the forearm on a piece of equipment that shines a light on the skin and measures the amount of light that is reflected back.
* Conduct an MRI scan of the kidneys, muscles, abdomen and heart. The MRI scan will take 60-70 minutes in total. The investigators will ask participants not to eat or drink anything two hours before the MRI scan.

After this visit, the investigators will ask participants to come back for two more study visits, which will be arranged at 12 and 24 months after their hospital discharge. These visits will consist of the same procedures and measurements done in the first study visit.

Eligibility Criteria:
Inclusion Criteria:

1. Adult patients aged 18 years or older.
2. Swab result positive for SARS-CoV-2.
3. Patients admitted to the hospital for ≥24 hrs.
4. Patients who received ICU care OR who sustained AKI stage 2/3 (as per KDIGO serum creatinine criteria).

Exclusion Criteria:

1. Patients \> 90 years of age.
2. Patients on haemodialysis or peritoneal dialysis or pre-existing CKD stage 5 (eGFR \<15ml/min/1.73m2).
3. Solid organ transplant.
4. Inability/refusal to give informed consent to participate.
5. Contraindications to MRI scan - claustrophobia, metal body implants, extensive tatoos, inability to lie supine for 1 hour.
The Impact of African American Women's Hair Care Practices and Hair Attitudes on Exercise Habits

The purpose of this research study is to better understand African American women's hair and hair styling practices and how these practices affect attitudes and viewpoints regarding exercise.


Eligibility Criteria:
Inclusion Criteria:

* Female between 21 and 60 years old.
* African, Afro-Caribbean, or African American decent.
* Able and willing to follow study procedures and successfully complete hair and exercise questionnaire/survey.

Exclusion Criteria:

* Unable to read or understand hair and exercise questionnaire/survey.
A Study to Learn About the Study Medicine Called PF-07799544 in People With Advanced Solid Tumors

The purpose of this clinical trial is to learn the safety and effects of the study medicine (PF-07799544) administered as a single agent and in combination with other study medications in people with solid tumors. This study is seeking participants who have an advanced solid tumor for which the available treatments are no longer effective in controlling their cancer. All participants in this study will receive PF-07799544. PF-07799544 comes as a tablet to take by mouth daily (initially 2 times per day, but this could change to once daily or another frequency). Depending on the part of the study, participants may also receive another study medicine.

* In the first part of the study, people with melanoma or other solid tumors may also receive encorafenib. Encorafenib comes as a capsule and is taken once per day.
* In the second part of the study, people with melanoma or other cancers with abnormalities in a gene called "BRAF" will receive PF-07799544 with other study medicines (for example, PF-07799933).

Participants may receive the study medicines for about 2 years. The study team will monitor how each participant is doing with the study treatment during regular visits at the study clinic.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of advanced/metastatic solid tumor including primary brain tumor for monotherapy phase 1a dose escalation
* Disease progressed during/following last prior treatment and no satisfactory alternative treatment options for monotherapy phase 1a dose escalation
* For Substudy B, histological or cytological diagnosis of advanced/metastatic melanoma
* For Substudy C, unresectable or adv/metastatic solid tumor progressed on, or with demonstrated intolerance to SOC, excluding melanoma,
* For Substudy B and C, measurable disease by RECIST version 1.1
* For Substudy B, evidence of a BRAF V600 mutation or BRAF Class II/III alteration in tumor tissue and/or blood
* For Substudy C, evidence of a BRAF founder alteration (non-V600 Class II/III BRAF alteration)

Exclusion Criteria:

* Brain metastasis larger than 4 cm
* History or current evidence of retinal vein occlusion (RVO) or concurrent neuromuscular disorder associated with elevated creatine kinase (CK)
Study of 18F-DCFPyL PET/CT Imaging in Patients With Prostate Cancer

This study evaluates the rate of radiological disease progression with the new 2nd generation positron emission tomography (PET) radiopharmaceutical, 18F-DCFPyL, in patients with metastatic castration (mCRPC) and non-metastatic (nmCRPC) castration resistant prostate cancer who have evidence of biochemical (PSA) disease progression without evidence of radiological disease progression on conventional standard radiologic testing (99mTc-methylene diphosphonate bone scan and CT).


Eligibility Criteria:
Inclusion Criteria:

* Histological confirmation of prostate cancer
* Patients receiving androgen deprivation treatment (ADT) with GnRH analogs, GnRH antagonists or bilateral orchiectomy of any duration.
* Cohort A: nmCRPC (status post- primary treatment with radical prostatectomy, radiation of any type or both)

  * Negative 99mTc-methylene diphosphonate bone scan and CT of the chest abdomen and pelvis within 6 weeks of 18F-DCFPyL PET/CT
  * Treatment with ADT with or without a second line novel AR targeted treatment (abiraterone, enzalutamide, or both) or 4 weeks after discontinuation of first generation antiandrogen (bicalutamide , flutamide, nilutamide- one or more permitted) for ≥ 12 months.
  * Rising PSA ≥ 10 ng/ml (confirmed by 2 determinations one week apart)
  * PSADT ≤ 9 months
* Cohort B: mCRPC

  * Treatment with ADT with or without abiraterone and or enzalutamide or both for ≥ 6 months and/or 4 weeks after discontinuation of first generation antiandrogen (bicalutamide , flutamide, nilutamide- one or more permitted).
  * PSA ≥ 2.0 ng/ml confirmed X 1 week apart, any PSADT
* Patients enrolled in other clinical trials are eligible if they satisfy all other criteria of eligibility.
* No new therapeutic interventions planned or scheduled to be instituted prior to the course of this study both on cohorts A and B before conventional radiologic progression is evidenced.
* Patients or their legal representatives must have the ability to read, understand and provide written informed consent for the initiation of any study related procedures.

Exclusion Criteria:

* Patient will be excluded from enrollment if he had a radioisotope within 5 physical half-lives prior to PET imaging
DPBRN Retrospective Cohort Study of Osteonecrosis of the Jaw

The purpose of this study was to determine the prevalence of ONJ in the patient population of 2 large HMOs and study the risk factors associated with the development of this condition.

The electronic database from Kaiser Permanente and HealthParnters of Minnesota were used to identify all ONJ cases that occured between 1994 and 2006 and then demographic, social and medical risk factors possibly associated with the disease were abstracted and analyzed.

Eligibility Criteria:
Inclusion Criteria:

* ONJ sufferers and control biphosphonate users older than 40, of any gender, race and ethnic origin
Coronary Access After Supra-Annular THV Implantation

To determine the optimal technique and equipment for selective coronary engagement specifically following Evolut THV implantation using commissural alignment.

Patients will undergo elective transfemoral TAVR with the Evolut THV. The operators will attempt to selectively engage both the right and left coronary arteries through standardized angiographic views. The CCI-CIC CoreLabs will adjudicate angiographic views, post-TAVR CT scan, and determine if the coronaries were selectively engaged. Catheter choice, adjunctive tools if needed (e.g guide extension, wires etc) and engagement technique will be at the discretion of the operator. All images and fluoroscopic views will be anonymized, saved and imported to the CCI-CIC Angiographic and CT CoreLabs.

Statistical analysis:

Patient baseline and outcome data will be presented as mean and standard deviation (SD) for normally distributed variables, median and interquartile range (IQR) for non-normally distributed variables, and frequency and proportion for categorical variables.

Eligibility Criteria:
Inclusion Criteria:

1. Patients undergoing elective transfemoral TAVR with the Evolut THV (Medtronic, Minneapolis, MN, USA).
2. Written informed consent to participate in the study.

Exclusion Criteria:

1. Hemodynamic or respiratory instability immediately prior to TAVR or during TAVR.
2. Advanced chronic kidney disease, defined as a GFR \<30 ml/min.
3. Valve-in-valve TAVR
4. Prior CABG
5. Aorto-ostial coronary artery disease.
6. Prior PCI of the left main or right coronary ostium
Randomized Trial Comparing Early "Trigger" Versus Delayed "Trigger" Timing in Cycles of Controlled Ovarian Stimulation.

This randomized trial will compare the efficacy of two different times of administration of medications for final oocyte maturation, commonly called a "trigger", in cycles of controlled ovarian stimulation (COS) for cycles in which all embryos will be cryopreserved ("freeze-all cycles").

This randomized trial will compare the efficacy of two different times of administration of medications for final oocyte maturation, commonly called a "trigger", in cycles of controlled ovarian stimulation (COS) for cycles in which all embryos will be cryopreserved ("freeze-all cycles").

1. The early trigger timing will be based on sonographic observation of at least three follicles reaching at least 17mm in diameter.
2. The delayed trigger timing will be based on at least three follicles reaching at least 22mm in diameter.

Eligibility Criteria:
Inclusion Criteria:

1. Adult female at least 18 years of age and less than 35 years of age intending to undergo ovarian stimulation for a cycle of IVF with all embryos to be frozen that attain the blastocyst stage.
2. Anticipated at least normal ovarian response evidenced by at least 8 antral follicles observed on ultrasound or a serum level of at least 1.5 ng/ml AMH.
3. Ability read and understand English sufficiently to obtain informed consent.
4. Patients with prior IVF cycles are allowed, but no patient can undergo more than one cycle with oocyte collection under this study.

Exclusion Criteria:

1. Any cycle type that would preclude immediate culture to blastocyst stage (e.g. oocyte banking).
2. Any condition that, in the opinion of the physician or principal investigator, would place the patient at undue risk under this protocol or would otherwise make the protocol inappropriate for that subject.
Meaning-Centered Psychotherapy at Home

The purpose of this study is to train nurses from the VNS Health Visiting Nurse Service to deliver Meaning-Centered Psychotherapy for Palliative Care Patients (MCP-PC) to homebound people, and to evaluate how effective MCP-PC is for people with cancer.


Eligibility Criteria:
Participant Inclusion Criteria:

Nurses (all phases):

* Per self-report, providing direct care services at VNS Health
* Per self-report, fluent in English\*\*
* Per self-report, is age 18 or older

Patients (all phases):

* Per health record and/or self-report, is a patient in the VNS Health home health agency division (post-acute care)
* Per health record and/or self-report, is age 18 or older
* Per health record, has a cancer diagnosis and a rating of ≥ 2 on Symptom Control Scale
* Per health record and/or self-report, fluent in English\*\*
* Has a score of ≥ 4 on Callahan cognitive screener
* Has a score of ≥ 4 on Distress Thermometer (N/A for Training Case Participants)

  * Language verification: For both nurses and patients, prior to enrollment, all will be asked the following two questions by a Clinical Research Coordinator (CRC) to verify

English fluency necessary for participation in the study:

1. How well do you speak English? (must respond "very well" or "well" when given the choices of Very well, Well, Not well, Not at all, Don't know, or Refused)
2. What is your preferred language for healthcare? (must respond English)

Participant Exclusion Criteria:

Nurses (all phases):

* Per self-report, planning to leave position at VNS Health in the next 6 months

Patients (all phases):

* Per health record and/or self-report, has a diagnosis of Alzheimer's, dementia, or other organic brain disorder and in the judgment of the PIs is unable to meaningfully participate.
* Per health record, has impaired decision-making capacity
* Per health record and/or self-report, is permanently placed in a nursing home
* Per health record and/or self-report, is currently receiving Hospice care
Safety, Tolerability and Pharmacokinetics of Etelcalcetide in Healthy Male Volunteers

The purpose of this study is to characterize the safety and tolerability of etelcalcetide in healthy young males.


Eligibility Criteria:
Inclusion Criteria:

* Male between 18 and 45 years of age who have provided written informed consent
* Subject is judged to be in good health based on medical history, physical examination, and routine laboratory tests

Exclusion Criteria:

* History or presence of any significant acute or chronic illness (e.g., cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, or neurologic disease) according to the investigator
* History of any ongoing medical condition requiring treatment with prescription medication
* History of asthma, severe allergies including skin reactions or prior anaphylactic type reactions
* Clinically significant abnormalities on screening clinical examination or laboratory safety tests
* History of drug or alcohol abuse
The RELIEF Study - Researching the Effectiveness of Lumbar Interventions for Enhancing Function

Low back pain (LBP) is one of the most common reasons for seeking medical care and accounts for over 3.7 million physician visits/year in the U.S. alone. Ninety percent of adults will experience low back pain in their lifetime, 50% will experience recurrent LBP, and 10% will develop chronic pain and related disability.

While there is growing evidence for the clinical effectiveness of alternative and complementary therapies to treat low back pain, little is known on the physiologic consequences and effects of these treatments. Further, additional data is needed to understand how these different treatment techniques effect clinical changes in pain and disability. The lack of empirical data hinders acceptance by the wider scientific and health-care communities, and it also limits the development of rational strategies for using alternative and complementary therapies.


Eligibility Criteria:
Inclusion Criteria:

* Report history consistent with chronic low back pain
* Average pain intensity at least mild when assessed with a numerical pain scale
* At least mild disability when assessed with a questionnaire
* Meets criteria for clinical prediction rule

Exclusion Criteria:

* A history of certain neurological, cardiorespiratory, and musculoskeletal disorders
* Have active cancer or be blind
* Report recent use of certain medications and treatments
* Report being pregnant, lactating, or that she anticipates becoming pregnant in the next 3-months
* Have too high body mass or unexplained weight loss
* Have clinical depression
* Have pending litigation related to the low back pain or are receiving any type of disability services
* Current drug or alcohol use that would interfere with adherence to study requirements
Endotracheal Intubation in Prehospital Scenario

We therefore designed this randomized crossover study to compare C-MAC with Macintosh laryngoscope in emergency intubation performed by paramedics according to three different intubator positions.


Eligibility Criteria:
Inclusion Criteria:

* give voluntary consent to participate in the study
* maximum 1 year of work experience in medicine
* minimum 50 clinical intubations
* paramedics

Exclusion Criteria:

* not meet the above criteria
* wrist or low back diseases
COVID-19 Study Assessing the Safety and Tolerability of Co-Formulated Anti-Spike (S) SARS-CoV-2 Monoclonal Antibodies (Casirivimab+Imdevimab) in Adult Volunteers

The primary objective of the study is to assess the safety and tolerability of co-formulated subcutaneous (SC) and intravenous (IV) casirivimab+imdevimab

The secondary objectives of the study are to:

* Explore variability in the drug concentration profiles of casirivimab and imdevimab after co-formulated subcutaneous (SC) or intravenous (IV) administration
* Characterize the immunogenicity of casirivimab and imdevimab in serum over time


Eligibility Criteria:
Key Inclusion Criteria:

1. Is healthy, or has chronic medical condition(s) that per the opinion of the investigator is (are) stable, well-controlled, and not likely to require medical intervention through the end of study
2. Does not require medication(s) for co-morbid condition, or has received stable medication(s) for co-morbid condition(s) for at least 6 months prior to screening
3. Weighs between ≥60 kg and ≤100 kg at the time of screening
4. Has SARS-CoV-2-negative reverse-transcriptase polymerase chain reaction (RT-PCR) from a sample collected ≤72 hours prior to randomization, using local assay and sample collection and assay standards
5. Has completed a full course of COVID-19 vaccination more than 6 weeks prior to randomization

Key Exclusion Criteria:

1. Has active respiratory or non-respiratory symptoms consistent with COVID-19 in the opinion of the Investigator
2. Has recent SARS-CoV-2 infection that resolved within 6 weeks prior to randomization
3. Prior use of casirivimab+imdevimab at any time prior to randomization
4. Prior, current, or planned use during the study of any of the following treatments: COVID-19 convalescent plasma, other monoclonal antibodies against SARS-CoV-2 (eg, bamlanivimab and etesevimab, sotrovimab), intravenous immunoglobulin (any indication), or any other investigational, authorized, or approved agent intended for COVID-19 treatment or prevention (with the exception of COVID-19 vaccines)
5. Treatment with another investigational drug in the last 30 days or within 5 half-lives of the investigational drug, whichever is longer, prior to screening
6. Body mass index (BMI) ≥28 kg/m2
7. Medically-attended acute illness, systemic antibiotics use, or hospitalization for any reason within 30 days prior to screening
8. Acute exacerbation of a chronic pulmonary condition (eg, chronic obstructive pulmonary disease \[COPD\], asthma exacerbations) in the past 6 months prior to screening
9. Uncontrolled hypertension, in the opinion of the investigator
10. History of heart failure hospitalization, diagnosis of a myocardial infarction, stroke, transient ischemic attack, unstable angina, percutaneous or surgical revascularization procedure (coronary, carotid, or peripheral vascular), or intracardiac device placement (eg, pacemaker) within 12 months prior to screening
11. Cancer requiring treatment currently or in the past 5 years, except for non-melanoma skin cancer or cervical/anus in-situ
12. Is pregnant at screening

Note: Other protocol-defined Inclusion/ Exclusion Criteria apply