cyrilzakka/clinical-trials huggingface dataset:
Impact of Nebivolol on Central Aortic Pressure

A randomized, cross-over, single-blind study to compare the effects of nebivolol and metoprolol on central aortic pressure and peripheral brachial pressure in patients with stable cardiovascular disease.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with history of hypertension
* Subjects who have received metoprolol for a minimum of 3 months

Exclusion Criteria:

* Patients who have had an acute myocardial infarction, coronary revascularization or who have been hospitalized for heart failure or cardiac arrhythmia in the past 6 months
Stand & Move at Work

A trial testing the efficacy of sit-stand workstations on decreasing sitting time and increasing light-intensity physical activity in samples of office worksites.

With traditional approaches to increasing MVPA (moderate to vigorous physical activity) in the workplace being unsustainable due to the requirement of deliberate and dedicated time away from work, this group-randomized trial will test the efficacy of sit-stand workstations on decreasing sitting time and increasing light-intensity physical activity (LPA) in a highly generalizable sample of office worksites using a multi-level intervention with high potential for dissemination.

Eligibility Criteria:
Inclusion Criteria:

Worksite-level inclusion criteria:

* Size: Small to moderate size worksite (20-60 employees)
* Schedule: \>80% of employees full time
* Occupation: Seated office work, primarily computer- and- telephone-based work, little movement or walking
* Wellness environment: Not currently undergoing a wellness program aimed at increasing activity at work
* Workstations: Willing to have sit-stand workstations installed at a worksite
* Willing to be randomized: Willing to be randomized to either intervention conditions

Member-level inclusion criteria:

* Age: 18 years and older
* Health status: Generally good health and able to safely increase LPA and reduce sitting time
* Employment status: Any sedentary job, sitting most of the say, little standing or walking
* Occupation: Traditional sitting desk, willing to have a sit-stand workstation installed at desk
* Workstation: traditional sitting desk;willing to have a sit-stand workstation installed at desk

Exclusion Criteria:

* contraindication to prolonged standing at work
Evaluation of Eye Health Benefits of Black Tomato Extract

Verification of the efficacy of black tomato extract for eye health.


Eligibility Criteria:
Inclusion Criteria:

* Age greater than 20 and capable of providing informed consent.
* Daily usage of 3C (computer, communication, and consumer electronics) for more than 6 hours (OSDI screening - those experiencing dryness and fatigue in the eyes).
* BMI between 22 and 35.
* High myopia population (-5.00 to -9.00D)

Exclusion Criteria:

* History of any eye surgery (e.g., strabismus surgery, refractive surgery).
* Presence of systemic diseases affecting the anterior surface of the eye.
* Long-term use of medications affecting the anterior surface of the eye.
Evaluation of Safety of SPARC0913 in Open Angle Glaucoma or Ocular Hypertension

The purpose of this study is to evaluate the long-term safety of SPARC0913. A multicenter, open label, non-randomized, uncontrolled, single group assignment, safety study of subjects with primary open angle glaucoma or ocular hypertension is planned. Subjects will receive study medication for a period of 24-weeks.

This is a multicenter, open label, non-randomized, single-arm, extension safety study to evaluate the long-term safety of SPARC0913. Subjects who completed the prior evaluator-masked clinical non-inferiority Study participated in the current study.

Eligibility Criteria:
Inclusion Criteria:

* Men and women aged ≥18 years
* Willing to participate and giving written informed consent
* Willing to commit to study medication-dosing, study visits and follow-up visits to complete evaluation
* Eligible to receive Latanoprost once a daily as monotherapy for treatment of glaucoma

Exclusion Criteria:

* History of allergic hypersensitivity or poor tolerance to latanoprost
* History of Substance abuse or addiction (alcohol drugs) in the past 3 years
* History of chronic use of concomitant medications in neurologic or psychiatric illness that would affect assessment of safety and effectiveness of the study medication
* Any abnormality preventing IOP measurement
HPV in Sinonasal Ca: Retrospective Analysis Association of Human Papilloma Virus (HPV) Serology and Behavioral Risk Factors

This is a case-control study designed to evaluate the role of anatomic site, gender and race in human papillomavirus-associated head and neck squamous cell cancers (HNSCC). We will explore the role of HPV, tobacco, alcohol and drug use, in HNSCC by tumor site with particular emphasis on the sinonasal cavity as well as differences in risk factors for HPV-positive HNSCC by gender and race.


Eligibility Criteria:
Inclusion Criteria:

* Cases:

  * Patients must be 18 years of age or older with a confirmed or suspected diagnosis of sinonasal cancer
  * Patients must have either a routine diagnostic biopsy of primary tumor or surgical resection planned as part of routine care (to allow for the collection of tumor sample for the study) or grant access to archival material, from a previously performed biopsy.
  * Willing to provide 20 mL blood sample
  * Ability to understand and the willingness to sign a written informed consent document
* Controls:

  * Must be 18 years of age or older within the categories of age, gender, and race needed to match cases
  * Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

* Cases:

  * Presence of medical or psychiatric condition affecting ability to give voluntary, informed consent
  * Participants who do not speak English and do not agree to use of a telephone or video interpreter will be excluded. However, if there is a hearing, literally or minor fluency issue and the participant requests assistance from a family member or the study coordinator, this individual may still enroll and receive this assistance to ensure they fully hear and understand everything being asked
* Controls:

  * Presence of medical or psychiatric condition affecting ability to give voluntary, informed consent
  * Participants who do not speak English and do not agree to use of a telephone or video interpreter will be excluded. However, if there is a hearing, literacy or minor fluency issue and the participant requests assistance from a family member or the study coordinator, this individual may still enroll and receive this assistance to ensure they fully hear and understand everything being asked
  * No prior diagnosis of head and neck cancer, except basal cell cancer
  * No previous radiation therapy of the head and neck
Creation of the BioBank, Early Detection and Discovery Biomarkers

To establish a multidisciplinary research structure for tissue repository that facilitates projects that bridge specialties that normally may or may not interact.

To establish a multidisciplinary research structure that facilitates projects that bridge specialties that normally may or may not interact. The tissue bank will build the platform for a novel application of translational research that links cutting edge molecular laboratory techniques to clinical outcome studies in a fast and direct manner. Tissue banks can be used for numerous discovery applications such as the identification and structural characterization of human genes, expression analysis, or discovery proteomics. Biological specimens, when coupled with standardized treatment and outcome data, will be essential resources for the identification, characterization, and validation of biomarkers that are predictive of disease and treatment.

Eligibility Criteria:
Inclusion Criteria:

* Male and female volunteers

Exclusion Criteria:

* N/A volunteers
Study of Pegilodecakin (LY3500518) With Nivolumab Compared to Nivolumab Alone Second-line Tx in Participants With Metastatic Non-Small Cell Lung Cancer

To compare the efficacy of pegilodecakin in combination with nivolumab versus nivolumab alone in participants with metastatic non-small cell lung cancer as measured by objective response rate.

This is an open-label, multi-center, randomized, Phase 2 study designed to compare the efficacy and safety of pegilodecakin in combination with nivolumab versus nivolumab alone in participants with stage IV / metastatic wild type non-small cell lung cancer and tumors with low tumor expression of PD-L1 (0-49%).

Eligibility Criteria:
Inclusion Criteria:

1. Participants must have histologically or cytologically confirmed Wild Type NSCLC that is stage IV / metastatic or recurrent
2. Participants must have received at least one prior systemic therapy that was not an anti-PD-1, anti-PD-L1 and/or anti-CTLA-4 treatment for the advanced stage of the disease
3. Participants with tumor tissue low expression of PD-L1 as defined by Tumor Proportion Score (TPS) 0% - 49%
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
5. Participants with measurable disease by spiral computed tomography (CT) or magnetic resonance imaging (MRI) per Response Evaluation Criteria in Solid Tumor (RECIST) v.1.1 criteria
6. Participants that have completed prior radiotherapy or radiosurgery at least 2 weeks prior to randomization

Exclusion Criteria:

1. Participants with active central nervous system (CNS) metastases or carcinomatous meningitis
2. Participants with any serious or uncontrolled medical disorder or active infection with the hepatitis virus or the human immunodeficiency virus (HIV)
3. Participants with Grade 1 (NCI-CTCAE v.4.03) toxicities attributed to prior anti-cancer therapy (other than alopecia and fatigue) prior to randomization
4. Participants that have received nivolumab
5. Participants that have received therapy with anti-tumor vaccines or other immuno-stimulatory antitumor agents
6. Participants with a history of severe hypersensitivity reactions to monoclonal antibodies
7. Participants that have received therapy with anti-PD-1, anti-PD-L1, anti-PD-L-2, anti-CD-137, and/or anti CTLA-4 antibodies
8. Participants receiving any investigational agent within 28 days of first administration of trial treatment
9. Pregnant or lactating women
Antibiotherapy During Therapeutic Hypothermia to Prevent Infectious Complications

Mild therapeutic hypothermia is currently recommended in management of cardiac arrests with shockable rhythm. In mechanically ventilated patients who were resuscitated after out-of-hospital cardiac arrests, mild therapeutic hypothermia side effects are conductive for infectious complications and especially for ventilator-associated pneumonia (VAP).

Despite high incidence of VAP and other infectious complications, it is not currently recommended to use antibiotic prophylaxis on the responsible germs. Yet VAP incidence could be decreased if an antibiotic therapy was systematically given to patient treated with mild therapeutic hypothermia after a cardiac arrest. Several retrospective studies showed less infectious complications but also decreased morbidity and mortality related to these complications when antibiotic therapy was given early to patients treated with therapeutic hypothermia after cardiac arrest.

Multicenter add-on randomized controlled double-blind trial assessing the efficacy of preventive antibiotics amoxicillin-clavulanic acid vs placebo to prevent occurrence of early VAP after out-of-hospital cardiac arrest receiving mild therapeutic hypothermia, in addition to usual VAP prevention measures.

Eligibility Criteria:
Inclusion Criteria:

* Older than 18 years-old, intubated and mechanically ventilated after out-of-hospital resuscitated cardiac arrest secondary to shockable rhythm
* Hospitalized in an ICU
* Mild therapeutic hypothermia procedure (32° to 35°C) scheduled (24 to 36 hours)
* Delay from ROSC to randomisation \< 6 hours
* Consent from family members or emergency consent

Exclusion Criteria:

* Pregnancy
* Out-of-hospital cardiac arrest secondary to non shockable rhythm and In-hospital cardiac arrest
* Need for cardiac support by cardiopulmonary bypass
* Ongoing antibiotic therapy or during the week before
* Ongoing or concomitant pneumonia
* Known chronic colonization with MRB
* Hypersensitivity to the active substances, to any of the penicillins or to any of the excipients.
* History of a severe immediate hypersensitivity reaction (e.g. anaphylaxis) to another beta-lactam agent (e.g. a cephalosporin, carbapenem or monobactam).
* History of jaundice/hepatic impairment due to amoxicillin/clavulanic acid, according to the latest version of the SmPC.
* Previous lung disease
* Predictable decision of early care limitation
* Patient under guardianship or curatorship
* Moribund patient
* Participation to another trial within 30 days
Supporting Use of AC Through Provider Profiling of Oral AC Therapy for AF

The SUPPORT-AF study aims to improve rates of anticoagulation (AC) in atrial fibrillation (AF) patients by developing and delivering supportive tools and educational materials to providers treating patients with AF. The investigators hypothesize that AC percentage will increase among providers receiving tools and educational content.

Nearly 1 million patients with atrial fibrillation (AF) who meet guideline criteria for anticoagulation (AC) are being left untreated, often due to providers over-estimating risks of bleeding and falling and under-estimating risks of stroke. The objective of this project is to improve rates of adherence to AC guidelines by creating supportive and educational materials for cardiology as well as primary care providers to evaluate the risks and benefits of prescribing AC to patients with AF. The investigators will email providers individual auto-updating reports containing their AC prescription rate compared to their peers and compared to practice level AC prescription goal. This report will also contain a list of the provider's AF patients who are eligible to receive AC based on their CHA2DS2-VASc stroke risk score ≥ 2 and a list of eligible AF patients with upcoming appointments to focus providers on an actionable group of patients with whom they might review the use of AC. The investigators will also message providers through the EHR prior to an upcoming appointment with an eligible patient reminding them to discuss AC if they deem appropriate. In addition, the investigators will directly engage with providers through academic teledetailing to educate providers on AC and address misconceptions and barriers to initiating or resuming AC in AF patients.

Eligibility Criteria:
Inclusion Criteria:

* University of Massachusetts providers caring for patients aged 18 years and older with ICD-10 diagnostic code consistent with AF or atrial flutter who had a visit with a primary care provider or
* cardiovascular medicine specialist in the previous one year with the diagnosis of AF present as an active diagnosis in the electronic medical record (EHR).

Exclusion Criteria:

* University of Massachusetts providers who do not care for patients aged 18 years and older with ICD-10 diagnostic code consistent with AF or atrial flutter who had a visit with a primary care provider or
* cardiovascular medicine specialist in the previous one year with the diagnosis of AF present as an active diagnosis in the EHR.
Endovascular Aneurysm Repair (EVAR) Gate Study

This study will evaluate a randomized comparison of direct versus snare techniques for cannulation of contralateral gate during an endovascular aneurysm repair (EVAR) procedure.

This information will be used to determine if primary snaring is superior to retrograde cannulation in decreasing procedural time and radiation exposure.

Endografts currently FDA-approved for abdominal aortic aneurysm (AAA) repair are modular systems,comprised of a main body (Aortic Trunk) and two legs (Ipsilateral Leg Endoprosthesis and a contralateral leg endoprosthesis). In placement of the endograft the main body and ipsilateral limb are deployed from a retrograde common femoral artery approach. From the contralateral femoral artery, cannulation of the contralateral gate is required to deploy the contralateral iliac limb.Cannulation of the contralateral limb gate is the portion of the operation that requires the most "wire skills." Depending on the patients' body type, angulations of the aorta and the size and volume of the AAA, this portion of the procedure can be technically difficult. This portion may become lengthy and discouraging if the surgeon fails to cannulate the gate using a particular approach. Cannulation of the contralateral limb gate from a retrograde femoral artery approach is commonly achieved by first using a maneuverable guidewire and steerable catheter. Antegrade or crossover cannulation involves passing a guidewire from the ipsilateral limb to the contralateral limb gate of the endograft, which can be accomplished with a curved catheter. The wire may be retrieved on the contralateral limb using a snare device. The problem and why it is important -- difficulty in accessing the contralateral gate leads to increase procedural time and excess exposure to radiation. The standard of care is retrograde cannulation with the use of crossover snare techniques as a secondary adjunct if retrograde cannulation fails. In this study we will compare retrograde cannulation to primary snaring.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18
* Patient is undergoing EVAR repair with a commercially available endograft
* Willing to give consent
* Procedure is Elective

Exclusion Criteria:

* Declines to participate
* Unable to provide consent
* Urgent AAA repair
* Participating in another study
DAILIES TOTAL1® Soft Contact Lenses - Post-Market Clinical Follow-up Study

The purpose of this study is to continuously assess the visual performance and safety of DAILIES TOTAL1 soft contact lenses in a real world setting and broader patient base through routine clinical practices. This activity will be used to continuously support delefilcon A (sphere, toric, and multifocal) soft contact lens regulatory requirements and standards.

This study includes a Baseline visit and a Year 1 visit.

The Baseline visit is defined as the first office visit where an eye care professional provided an in-person office biomicroscopy exam to the subject before or during which a DAILIES TOTAL1 sphere, toric, or multifocal soft contact lens prescription was released. The Baseline visit will be retrospective. All assessments at baseline will be obtained from chart reviews.

The Year 1 visit is defined as the visit that occurs 1 year (-2/+4 months) since the Baseline visit during which period the subject is wearing prescribed lenses and a contact lens examination is performed. The Year 1 visit can be either retrospective or prospective in subjects 7 to less than 18 years of age. For subjects 18 years of age and older, the Year 1 visit will be retrospective.

Eligibility Criteria:
Key Inclusion Criteria:

* At baseline: 7 years of age or older for sphere and toric wearers, 40 years of age or older for multifocal wearers.
* Wearers of delefilcon A (sphere, toric, or multifocal) soft contact lenses of the same design in both eyes who have already begun use of the lens type and have purchased at least 3-month supply of lenses at baseline.
* Best corrected distance visual acuity (BCVA) 20/25 or better in each eye at baseline.
* Other protocol-defined inclusion criteria may apply.

Key Exclusion Criteria:

* Any ocular disease or condition that would contraindicate contact lens wear at baseline.
* Use of systemic or ocular medications that would contraindicate contact lens wear at baseline.
* Other protocol-defined exclusion criteria may apply.
Registry of Sustained Immunity to COVID-19 Among ESKD Patients

This is a multi-center, prospective registry study of subjects undergoing hemodialysis for treatment of end-stage renal disease in a DaVita center.

The objective of this study is to understand whether and to what degree anti-SARS-CoV-2 antibodies mitigate the risk of subsequent SARS-CoV-2 infection and COVID disease within the ESKD population.

This is a multi-center, prospective registry study of subjects undergoing hemodialysis for treatment of end-stage renal disease in a DaVita center.

The objective of this study is to understand whether and to what degree anti-SARS-CoV-2 antibodies mitigate the risk of subsequent SARS-CoV-2 infection and COVID disease within the ESKD population.

Following informed consent, participants will undergo baseline serologic characterization for anti-SARS-CoV-2 IgM and IgG. The study is planned to align with the present wave of COVID-19. Enrollment will continue until the total sample size of 2500 is reached or until the study sponsor determines. Should there be a subsequent wave of COVID- 19, participants will be actively surveiled for evidence of SARS-CoV-2 infection and for COVID-19 disease. The relationship between baseline serologic status and subsequent infection/disease will be determined.

This study will have 2 distinct phases.

Phase 1 (baseline characterization) start will be triggered by the sponsor and may start at different times at the active sites. Participants will be consented and enrolled and blood will be collected for anti-SARS-CoV-2 antibodies.

Phase 2: Start will be triggered by the sponsor in the fall of 2020 and each geographic study location may be triggered to start at separate times. Study participants will be followed prospectively for incidence and severity of COVID-19. Study visits will commence upon sponsor trigger and will occur once monthly for 4 months.

Eligibility Criteria:
Inclusion Criteria:

* Between ≥18 and 80 years of age, inclusive.
* Ability to provide informed consent.
* Currently receiving hemodialysis treatment for end-stage kidney disease at a DaVita dialysis center.

Exclusion Criteria:

-
Creatine and GAA for Brain Oxygenation

The main aim of this randomized controlled trial is to evaluate cerebral blood oxygenation after 7-day administration of a creatine-guanidinoacetic acid (GAA) mixture in healthy adults before, during, and after a series of cognitive tests.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-30 years
* Absence of metabolic disorders or other health complications
* Provision of signed informed consent

Exclusion Criteria:

* History of dietary supplement use within the preceding 4 weeks
* Lack of consent to randomization
* Concurrent participation in other studies
Manicaland VMMC Uptake Through Behavioural Incentives Trial

Primary Objective The purpose of this study is to evaluate the impact of an interactive VMMC education session offered by a circumcised health worker and contribution to transport costs for accessing VMMC along with either (1) conditional economic compensation for wages or (2) lottery-based economic incentives on the uptake of VMMC.

Hypothesis VMMC education session offered by a role model - a young male health worker who has been previously benefited from VMMC services in this community - addressing risks of HIV infection, benefits of VMMC, and the fear of pain associated with VMMC, with/without a conditional fixed or lottery-based financial incentives off-setting present-biased preferences, will improve risk perception and increase uptake of VMMC in HIV-negative young men.

Study outcomes The primary outcomes for the study will be risk perception measured in a follow-up survey at 6 months and proportion of men taking up VMMC within 6 months measured through self-reports and matched to program records.


Eligibility Criteria:
Inclusion Criteria:

* Men
* Age 15-29 years

Exclusion Criteria:

* Participants testing HIV-positive at baseline
* Self-reporting have already undergone circumcision