cyrilzakka/clinical-trials huggingface dataset:
Atorvastatin and Clopidogrel HIgh DOse in Stable Patients With Residual High Platelet Activity

The purpose of this study is to evaluate if high-dose (80mg/day) atorvastatin might exert an adjunctive anti-platelet effect compared to high-dose clopidogrel (150mg/day) in stable patients with high on-treatment reactivity according to a point-of-care platelet function assay.

This is a prospective, randomized, open-label, control-active trial performed in elective patients candidates to coronary drug eluting stent implantation who presented high-on-treatment platelet reactivity, immediately before coronary intervention (PCI). All patients are treated with aspirin (100 mg/day) and standard-dose clopidogrel (600 mg as loading dose and 75 mg daily as maintenance dose)for at least 7 days before PCI. Platelet function is assessed by the VerifyNow P2Y12 assay (Accumetrics, San Diego, CA). Patients are eligible to be enrolled if they have high-on-treatment reactivity defined as P2Y12 reaction units (PRU) \>= 230, immediately before PCI. After PCI, patients are randomized to receive high-dose clopidogrel (150 mg daily) or high-dose atorvastatin (80mg/day) + high-dose clopidogrel (150 mg daily). Study visits and platelet function testing with the VerifyNow P2Y12 test are conducted at 7 and 30 days after randomization.

Eligibility Criteria:
Inclusion Criteria:

* Stable angina
* candidates to drug eluting stent implantation
* High on-treatment platelet reactivity according to a point-of-care platelet function test

Exclusion Criteria:

* chronic therapy with statins
* inability to provide informed consent
* intolerance to statins
* acute or chronic liver failure or ALT \> 2 times ULN
* known myopathy
* CKD stage IV or dialysis treatment
* pregnancy or breast-feeding
* malignancy
A Prospective Study of RISE for Physicians

The purpose of this study is to determine whether the RISE for Physicians program has a significant impact on physicians' burnout, resilience, insight, self-compassion, empowerment, and professional and personal mental health and well-being.

This study will include 36 subjects recruited from employed physicians and non-employed physicians with privileges at AdventHealth. The study will include data collection along with program participation. Program will consist of a 2.5 day retreat facilitated by a licensed mental health professional. Data collection will be at 3 timepoints and include 10 surveys that are expected to take 30 minutes to complete.

Eligibility Criteria:
Inclusion Criteria:

* AdventHealth employed or contract physician
* Or non-employed physician with AdventHealth privileges (hospital, emergency room, or AHMG practice)

Exclusion Criteria:

* A resident physician
* Advanced practice provider
* Executive leader
Impact of Metabolite Supplementation to Restore Mitochondrial Dysfunction During Septic Shock: a Preclinical Study

Septic shock is defined as a subset of sepsis with severe metabolism alterations, leading to organ failure. Septic shock is associated with a high mortality, around 40% according to the SEPSIS 3 definition.

Metabolic alterations are responsible for lactic acidosis, and results in mitochondrial dysfunction.

This study aims at evaluate the impact of exogenous metabolites on restoring mitochondrial function in septic shock patients with lactate acidosis.

Mitochondrial metabolism (quantitative analysis, mitochondrial function) in intact Peripheral Blood Mononuclear Cells (PBMC) will be isolate and analyse from patients at the early phase of septic shock (admission), at day 2 and 4. Participant's medical history will be recorded: renal and liver metabolism, severity scores and outcomes and the need for supportive care in the intensive care unit (ICU) until 28 days after admission.

Furthermore, the investigators will evaluate wether selected metabolites added to the cell culture medium may improve mitochondrial metabolism.

In this prospective study, the investigators will include patients admitted to the medical ICU of Angers University Hospital and meeting the SEPSIS-3 criteria for the definition of septic shock (Sequential Organ Failure Assessment (SOFA) score \> 2, hyperlactatemia \> 2 mmol/L and sepsis).

Blood samples will be collected during the usual care of initial resuscitation and analyzed in the laboratory INSERM (Institut national de la santé et de la recherche médicale) U1232 (University Hospital of Angers).

Mitochondrial metabolism will be analyzed in freshly isolated PBMC and after culture for 1-3 days, with or without the addition of selected metabolites to the cell culture medium.

The evolution of ketogenesis, mitochondrial function, acidobasic status will be assessed across the time (blood samples at day 2 and 4).

Survival, renal and liver metabolism, severity scores and outcomes and the need for supportive care in the intensive care unit (ICU) until 28 days after admission will be recorded.

Eligibility Criteria:
Inclusion Criteria:

* All patients aged 18 or more
* Patients with criteria for septic shock according to SEPSIS 3 definition (presumed sepsis, with persisting hypotension requiring vasopressors to maintain mean arterial pressure \> 65 mmHg and having a serum lactate \> 2 mmol/L despite adequate fluid expansion).
* Admitted in the ICU of Angers University Hospital

Exclusion Criteria:

* Minor patients (aged less 18)
* Patient subject to legal protection measures
* Refusal of the patient or his family
* Preexisting mitochondrial disease
* Patient with aplasia
* Pregnant or parturient women
Evaluating 18F-FDG PET/CT With Liver SUVmax-based Criteria for Prognosis of Patients With Natural Killer/T-cell Lymphoma

The purpose of this study is to evaluate whether a semi-quantitative interpretation using the liver SUVmax as reference can better interpret 18F- FDG PET/CT and predict disease progression during chemotherapy or survival in NK/T-cell lymphoma.

In this study investigators develope a semi-quantitative interpretation using the liver SUVmax as reference to interpret 18F-FDG PET/CT. Positive lesions in PET were indicated as SUVmax of residues higher than the threshold or new 18F-FDG avid lesions. Investigators compare the prognostic accuracy of the liver SUVmax-based criteria with the 5-PS criteria and ΔSUVmax interpretation with respect to predicting disease progression during chemotherapy or survival in NK/T-cell lymphoma. Furthermore,investigators improve the prognostic ability of interim PET/CT by comparing the results to the clinical prognostic factors.

Eligibility Criteria:
Inclusion Criteria:

* newly diagnosed NK/T-cell lymphoma
* treated using an anthracycline-containing regimen
* minimal follow-up at 6 months after the completion of first-line treatment
* complete medical history and clinicopathological data

Exclusion Criteria:

* secondary malignant disease
* serious infection or inflammation (e.g., HIV)
* primary central nervous system lymphoma
* hepatic or renal dysfunction.
AcQMap 2.1 With Electro-Magnetic Tracking System Feasibility Study (EMT Feasibility Study)

Non-Significant Risk Clinical Study

Clinical Investigational Use Only for the purposes of collecting electromagnetic tracking data to validate the use of the device in a clinical setting.

The EMT Feasibility Study is a prospective, multi-center, feasibility study designed to demonstrate the feasibility of EMT solution in conjunction with the AcQMap 2.1 System's existing capabilities.

The objective of the study is to demonstrate the ability of the AcQMap 2.1 System to support EMT in conjunction with the existing impedance localization capabilities. The new EMT technology is expected to continuously provide fully synchronized and similar localization information to the impedance-based localization information associated with the location of the catheter's magnetic sensor position.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female 18 years of age or older.
2. Currently scheduled for the ablation of an atrial arrhythmia utilizing the diagnostic AcQMap 2.1 System.
3. Willing and able to give written informed consent.

Exclusion Criteria:

1. In the opinion of the investigator, any contraindication to the planned ablation, including anticoagulation contraindications, atrial thrombus, renal failure, or sepsis.
2. Current enrollment in any study protocol sponsored by Acutus Medical
3. Any other condition that, in the judgment of the investigator, makes the participant a poor candidate for this procedure, the study, or compliance with the protocol (includes vulnerable patient population, mental illness, addictive disease, extensive travel away from the research center, etc.).
Study to Learn More About Outcomes Reported by Patients Suffering From Type 2 Diabetes Using a Digital Data Collection Tool

In this study researchers want to gain more information on patients who are treated with Metformin for their Type 2 Diabetes. Adult female and male patients with a prescription of a Metformin containing drug will be invited to the study in a public pharmacy after the decision for treatment with Metformin has been made by the treating physician. The pharmacist will provide interested participants access to a special phone App and participants are asked to complete via this phone App a questionnaire on their health situation with special focus on their Type 2 Diabetes. This includes questions on complications and self-care activities in relation to their diabetes, questions on quality of life and health history. There will be no extra visit to the treating doctor or a pharmacy. The study is aiming to have the questionnaire completed by 300 participants.


Eligibility Criteria:
Inclusion Criteria:

* Adult female or male patient
* Valid prescription for a Metformin containing drug approved in Germany
* Decision to initiate treatment with Metformin was made by the treating physician as part of the routine treatment practice
* Signed informed consent

Exclusion Criteria:

- Not applicable
Return to Work With Post Stroke Communication Disorders

Approximately a quarter of stroke survivors are of working age, and it is well-known that disabilities caused by stroke can lead to difficulties returning to work. In addition to the economic cost, being out of the workplace due to disability has major psychosocial costs for the individual, causing reduced sense of purpose, quality of life, and standard of living. Communication problems (which can affect reading and writing, as well as producing and understanding speech) are not as visible as other stroke-related problems such as a weak arm or difficulties walking. However, they can cause major problems for returning to work because of the importance of communication across a vast range of work activities, for example as a means to engage with colleagues, to share information in order to solve problems and resolve conflicts, and as a means to ensure health and safety. There has been little research into the effects of communication problems on returning to work after a stroke, so the investigators want to explore this issue. Specifically, the investigators want to find out what helps and what hinders people with communication disorders following a stroke when they attempt to return to work; what information and support is most helpful to them; how this information and support should be given and by whom. The investigators aim to do this by interviewing people across NHS Grampian who have the experience of attempting to return to work with post-stroke communication problems. The investigators will then look at all the interviews together and find the common feelings or experiences that the participants mentioned. The findings will be written up and shared widely with professionals and with stroke survivors. The knowledge gained will help the investigators to plan a programme to help people with these problems to return to work.


Eligibility Criteria:
Inclusion Criteria:

Adults (aged 18 years of age and over) will be eligible if:

* they have had a stroke (excluding Transient Ischemic Attacks, or mini strokes) within the last 2 years
* they were in paid employment or actively seeking work at the time of their stroke
* they are attempting or have attempted (whether or not successfully) to return to paid employment since their stroke.

Exclusion Criteria:

Individuals will be excluded if:

* they lack the capacity to consent
* they are considered to have insufficient English language skills to be able to engage effectively in an interview, given that this is a small-scale study which will not have the resources to fund interpreter services
* they have a diagnosis of a learning disability, dementia or another comorbidity deemed to be as or more significant than the stroke in their experience of return to work.
Compare Endoscopic and Open Methods of Vein Harvesting for Coronary Artery Bypass Grafting

There is no shared vision relating to integrity and quality of the conduit after the impact on the vein wall during vein harvesting. In this connection, the investigators studied the initial state of the venous conduit, interoperation damages of the vein and postoperative wound complications while using two methods of GSV harvesting.

The great saphenous vein (GSV) remains one of the most commonly used conduits due to its ease of harvest, availability and versatility \[1\] Traditional harvesting of GSV is open vein harvesting, which involves an extended leg incision. This technique is associated with a significant morbidity and wound complications occur in 2-24% of cases.

Minimally invasive techniques endoscopic vein harvesting (EVH), have therefore been developed to reduce post-CABG leg wound complications. Last time the endoscopic vein harvesting is the method of choice in many centers as it allowed reduction of post-surgical complications as compared to the open method. Although long-term graft patency following EVH has been questioned cohort studies have reported that the technique is safe and effective.

The possibility to use lymphoscintigraphy for evaluation of lower limb lymphatic system after vein harvesting for the coronary artery bypass surgeries was reported before. Nevertheless, the state of the lymphatic system after vein harvesting remains to be poorly studied.

Currently, there is no shared vision relating to integrity and quality of the conduit after the impact on the vein wall during vein harvesting. In this connection, the investigators studied the initial state of the venous conduit, interoperation damages of the vein and postoperative wound complications while using two methods of GSV harvesting.

Eligibility Criteria:
Inclusion Criteria:

* subjects with multivascular lesion of the coronary artery to whom coronary artery bypass surgery was indicated.

Exclusion Criteria:

* urgent coronary artery bypass surgery with unstable haemodynamics;
* previous coronary artery bypass surgery;
* chronic venous insufficiency С4-С6 under СЕAR classification;
* previous limb surgeries.
McNeel Eye Center Corneal Crosslinking Study

This study will investigate the effectiveness in treating keratoconus, pellucid marginal degeneration and post LASIK iatrogenic ectasia utilizing fluence rates and treatment times of Corneal Cross Linking other than the original FDA approved protocol of 3mw/cm2.

Patient recruitment will include a patient population of 100 individuals from 15 years to 50 years old with established keratoconus, pellucid marginal degeneration or post-LASIK ectasia determined by keratography. A solution of transepithelial riboflavin .25% will be applied every three minutes for 30 minutes or until complete corneal penetration is observed. Then the cornea will be irradiated with UV light at fluence rates of 9mw/cm2 for 10 minutes or 18 mw/cm2 for 5 minutes. Post procedural evaluation will take place at day one, day 7 day 30, day 90, day 180 and day 365. Pretreatment keratography, uncorrected acuity, best corrected acuity will be compared at follow up days beginning on day 30.

Eligibility Criteria:
Inclusion Criteria:

* Males or females between the ages of 15 and 50 with keratoconus diagnosed topographically with or without other corneal ectatic disease.

Exclusion Criteria:

* Prior corneal transplantation, pregnancy, inability or unwillingness to adhere to follow up protocol.
Telehealth-Enhanced Assessment and Management After Stroke-Blood Pressure

TEAMS-BP is a multicenter, participant-randomized controlled trial designed to compare the effectiveness of Intensive Tailored Telehealth Monitoring (ITTM) versus Intensive Clinic Management (ICM) on Blood Pressure (BP) control and patient activation for BP management following stroke

The Feasibility phase will allow for a period in which to pilot implementation and evaluation of all systems for data acquisition, clinical management, and collection of 3-month outcomes. The study uses a parallel, 2-arm design with 1-to-1 randomization to treatment group. Randomization will be performed at the participant level, stratified by center, age (18-74, 75+), and race (Black/African American, non-Black/African American).

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of ischemic stroke defined as acute brain, spinal cord, or retinal infarction based on objective evidence on imaging (such as a focal area of restricted diffusion on Magnetic Resonance Imaging \[MRI\]) in a defined vascular distribution or clinical evidence of focal ischemic injury based on symptoms persisting \> 24 hours; or spontaneous hemorrhagic stroke defined as a focal collection of blood within the brain parenchyma that is non-traumatic and identified by brain computed tomography (CT) or brain MRI
* Age ≥18 years
* Discharged directly home from acute care or inpatient rehabilitation
* SBP\>130 at the post-acute clinic visit (within 21 days of discharge) \& at Study Visit 1 (within 31 days of discharge)
* Able to read and understand English or Spanish
* Have access to a functioning smartphone or tablet with broadband access (required for the intervention)
* Willing to install and use a study-compatible physical activity monitoring application on their smartphone or smartphone of a qualifying caregiver
* Stated agreement to participate in either intervention to which they are assigned and attend all required study visits
* Consent to receiving Short Message Service (SMS) required as part of the study interventions
* Provision of a signed and dated informed consent form

Exclusion Criteria:

* Subdural hematoma or subarachnoid hemorrhage
* Current participation in another stroke clinical trial precluding dual enrollment
* Presence of terminal illness, such as cancer, that limits life expectancy to \<1 year
* Diagnosis of end-stage renal disease defined as permanent kidney dysfunction requiring the use of hemodialysis or peritoneal dialysis
* Pregnancy, lactation or planning to become pregnant
* Late-stage Alzheimer's disease or related dementia
* Transitioned to a facility such as skilled nursing or long-term care prior to enrollment
* Any condition that in the opinion of the study investigator would preclude the participant from being able to safely participate in the trial
Helping Those With Mental Illness Quit Smoking

This study tests whether pre-cessation interventions known to be effective in the general population will increase acceptance of evidence-based treatment, engagement and compliance with that treatment and initial quitting success. One hundred and seventy two patients will be recruited from 13 Community Support Programs (CSPs). CSPs provide community based care to those diagnosed with persistent and serious mental illness. All participants will receive two group sessions (40 minutes each) modeled after "Kicking Butts", a group-based quitting preparation program used for the past four years in two Milwaukee CSP programs run by Wisconsin Community Services. Individuals will then be randomly assigned to the experimental and control conditions (n=86 each). Experimental subjects will receive four evidence-based preparatory interventions (motivational interviewing, smoking reduction, practice quit attempt, and pre-quit use of nicotine replacement medication) (25 - 30 minutes each). Attention control subjects will also receive four individual sessions of the same duration. However their individual sessions' content will be a discussion of the personal relevance of the group material and will not include any of the preparatory interventions. Data will be collected via brief surveys taken pre-intervention, at the end of the last individual session, and three months later and from a database provided by the Wisconsin Tobacco Quit Line (WTQL).


Eligibility Criteria:
Inclusion Criteria:

* current smoker (smoking daily or smoking at least 10 cigarettes per week) (use of other tobacco products permitted such as chew and snuz in addition to smoking)
* not willing to make a quit attempt
* willingness to use the nicotine patch
* plans to remain in the area for the next five four months.

Exclusion Criteria:

* current use of any cessation medicine (nicotine patch, nicotine gum, nicotine lozenge, nicotine inhaler, nicotine nasal spray, bupropion, Wellbutrin, Zyban,Chantix or varenicline)
* previous serious skin reaction or other allergic reaction to using the nicotine patch
* stroke, heart attack or abnormal electrocardiogram in past four weeks
* pregnancy, plans to get pregnant or nursing
* exclusive use of other tobacco products (non-smoker tobacco user)
* having a court-ordered guardian, or an activated power of attorney for health or observation by researchers during the consent procedure that suggests diminished decision making capacity
Cronic Pressure Wounds and Relation With Gender

There is no exact scientfic data about gender relationship with cronic pressure wounds (CPW). This research is aimed first to reveal gender relationship with CPW and aimed secondarily to reveal the gender related couse(es).

There is no exact scientific data about gender relationship with cronic pressure wounds (CPW). Researches about this subject is generally related to prevention and management of the process. But gender difference is not exactly researched in the literature. This research is aimed first to reveal gender relationship with CPW and aimed secondarily to reveal the gender related couse(es).

Eligibility Criteria:
Inclusion Criteria:

* Cronic pressure wound patients

Exclusion Criteria:

* Operated cronic pressure wounds