cyrilzakka/clinical-trials huggingface dataset:
Magenta Elevate™ First-in-Human Clinical Study in High-Risk PCI Patients

The Elevate™ First-In-Human (FIH) study is designed to evaluate the initial safety and device functionality of the Elevate™ percutaneous Left Ventricular Assist Device (pLVAD) System in patients undergoing non-emergent, high-risk percutaneous coronary interventions.

The Elevate™ System FIH study is planned as a prospective, single-arm, interventional study of up to 20 patients.

The Magenta Elevate™ is a temporary (≤ 6 hours) ventricular support device indicated for use during high-risk percutaneous coronary interventions (HR-PCI) performed electively or urgently in hemodynamically stable patients, with severe coronary artery disease.

The Magenta Elevate™ Pump is a catheter-mounted, self-expanding and retrievable pump, designed to unload the left ventricle by actively transporting blood from the left ventricle into the ascending aorta.

Eligibility Criteria:
Inclusion Criteria:

1. Non-emergent, percutaneous coronary intervention is planned in at least one stenotic lesion of a native coronary artery or bypass graft (de novo or restenosis)
2. Ejection fraction of ≤ 45% and at least one of the following:

   1. Intervention on an unprotected left main coronary artery
   2. Intervention on a last patent coronary conduit
   3. Three-vessel disease (in case of left coronary artery dominance, the combination of a Left Anterior Descending Artery (LAD) lesion and a proximal Left Circumflex Artery (LCX) lesion qualifies as three-vessel disease)
3. Femoral artery diameter compatible with the use of Elevate™
4. Subject signed informed consent

Exclusion Criteria:

1. Subject age \< 40 or ≥ 83 years
2. Cardiogenic shock
3. Left ventricular mural thrombus
4. Presence of a mechanical aortic valve or a heart-constrictive device
5. Aortic stenosis
6. Moderate or severe aortic regurgitation (≥ 2+ by Transthoracic Echocardiography)
7. Severe peripheral vascular disease
8. Aortic pathology, such as aortic aneurysms, extreme tortuosity or calcifications that could pose an undue additional risk to the placement of a pLVAD device
9. Chronic renal dysfunction (serum creatinine ≥ 3.5 mg/dL)
10. Uncorrectable abnormal coagulation parameters (defined as platelet count ≤ 75,000 or INR ≥ 2.0 or fibrinogen ≤ 1.5 g/L)
11. Active systemic infection
12. Stroke or transient ischemic attack within 3 months of enrollment
13. Female subjects who are pregnant or breast-feeding
Increasing Treatment Adherence in Co-Occurring Psychiatric and Drug Use Disorders

The investigators are proposing a study of treatment adherence in co-occurring psychiatric and drug use disorders (COD). The proposed study uses a 3-cell/condition design, within which 75 adult outpatients with co-occurring psychiatric disorders and drug abuse/dependence (CODDA) will be randomly assigned to one of the following brief, 8-week, manual-guided interventions following a 2-week "Assessment Only" baseline period:

1. Adherence Feedback (AF); this condition will entail weekly, 20-25 minute sessions of AF, which is a procedure that represents a technological advancement developed by Cramer et al. (1989, 1995, and 1999) and is based on the use of adherence data from the microelectronic monitor in Medication Event Monitoring System (MEMS) caps,
2. AF + Contingency Management (AF + CM); in this condition, participants will receive AF, as described above, PLUS contingency management. CM is based on the behavioral learning theory, which suggests that the occurrence of a behavior is increased as a function of the rate at which it is positively reinforced or rewarded, or
3. AF + Motivational Enhancement Therapy (AF + MET); in this condition, patients will receive AF, as described above, PLUS motivational enhancement therapy. MET is based on the idea that an effective way to motivate behavior change is to assist patients in clarifying their ambivalence (i.e., reasons for and against changing/adhering), utilizing a series of strategies based on client-centered psychotherapy, self-efficacy theory, and social psychology.

The study will allow the evaluation of three hypotheses:

1. AF + MET is superior to AF + CM,
2. AF + MET is superior to AF alone, and
3. AF + CM is superior to AF alone.

Primary outcome measures are:

1. rates of adherence to medication (i.e., selective serotonin reuptake inhibitors or SSRIs), as measured by MEMS caps and self-report,
2. rates of counseling attendance, and
3. reductions in illicit drug use, including achievement of abstinence, as assessed by twice-weekly urine toxicology tests and self-report.

Secondary outcomes include reductions in psychiatric symptomatology and rates of re-hospitalization. The investigators will also evaluate the relationship between adherence and primary and secondary outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Currently being treated with any class of psychotropic medication
* Have used illicit drugs or abused prescription drugs within the past year
* Are not adhering completely to their medication

Exclusion Criteria:

* Current major depressive episode
* Active suicidal/homicidal ideation/intent
* Current manic episode
* Visiting nurse or living in a facility that distributed medications
Single Dose Escalation Study of 131I-Sibrotuzumab in Patients With Advanced or Metastatic Non-small Cell Lung Cancer

Study to determine the maximum tolerated dose (MTD) and safety profile of a single-dose administration of sibrotuzumab (50 mg) conjugated to an increasing dose of 131 I isotope.


Eligibility Criteria:
Inclusion Criteria:

* Evidence of advanced, non-resectable, and/or metastatic non-small cell lung cancer and at least one previous conventional treatment for advanced disease
* Eastern cooperative Oncology Group (ECOG) performance status of 0 or 1
* Measurable or evaluable disease, determined by World Health Organization (WHO) criteria using standard imaging modalities, including ultrasound, X-ray, CT and/or Magnetic Resonance Imaging (MRI). Bone scans and/or antibody scans are not to be used to determine the extent of the disease
* Expected survival of ≥ 16 weeks
* At least 18 years of age
* Platelet count ≥ 100 x 10\*\*9/L
* Absolute neutrophil count ≥ 2.0 x 10\*\*9/L
* Aspartate aminotransferase (AST) ≤ 3 x upper limit of normal or \< 5 x upper limit of normal if liver metastases are present
* Total bilirubin ≤ 2mg/dL
* Serum creatinine ≤ 2mg/dL
* Ability to provide written informed consent

Exclusion Criteria:

* Known brain metastases
* Exposure to an investigational agent within 30 days prior to receiving the scout dose
* Incomplete recovery from surgery or incomplete healing of an incision site or evidence of infection
* Treatment with cytotoxic chemotherapy, radiation or immunosuppressive therapy within the 30 days (42 days for nitrosoureas and/or mitomycin C) of the scout infusion. Patients using inhaled corticosteroids are considered eligible for enrollment
* Serious illnesses, i.e., active infections requiring antibiotics, bleeding disorders or other serious illnesses precluding the use of either 131I or sibrotuzumab
* Women who are breast-feeding or pregnant
* Men and women who were sexually active and are unwilling to utilize a medically acceptable method of contraception
* Hypertrophic skin disease or autoimmune disease that possibly involves over-expression of fibroblast activation protein (FAP), which can be targeted by the antibody. These diseases include active inflammatory arthritis, cirrhosis, and keloids
* Unstable angina pectoris. Patients prescribed medication to control their angina pectoris must have been on a fixed dose for at least 1 month prior to screening to be eligible for trial enrollment
* Myocardial infarction within 3 months prior to screening
* New York Heart Association (NYHA) Heart failure stage III or IV, or a left ventricular ejection fraction of ≤ 40 %
* Impaired lung function, measured by a decrease in forced expiratory volume at one second (FEV1) to less than 50 % of the predicted normal value
The Effect of Smile Designs on Aesthetic Perception

The goal of this observational study is to examine the effect of designs using different aesthetic dental proportions made with the digital smile design program on the aesthetic perception of individuals of different ages, gender, and educational status.

The main questions it aims to answer are:

1. The golden ratio is the most aesthetic ratio known and accepted in dentofacial structures.
2. There is no significant difference between the aesthetic perception of dental students, dentists, specialist dentists and laypeople.

Participants will answer:

* The first 5 questions related that demographic data such as age, gender, and educational status.
* The smile designs of a woman and a man, prepared according to 8 different principles, will be evaluated by the participants according to the Likert scale.

Researchers will compare the 4th and 5th-grade students of a dentistry faculty, dentists, specialist dentists and laypeople to see the effect of smile design on facial aesthetic perception.


Eligibility Criteria:
Inclusion Criteria:

* Anyone who can answer the survey online

Exclusion Criteria:

* individuals under the age of 18
Red Flags for Cardiac Examination for Early Detection of Congenital Heart Disease

The study done to identify the relation between the presence of abnormal clinical cardiac findings and the echocardiographic findings in newborn infants.

A full history will be taken, complete general systemic and cardiac examination will be done. All patients with abnormal physical cardiac examination in the neonatal period (≤ 28 days of age) according to the inclusion criteria will have echocardiographic examination.

Eligibility Criteria:
Inclusion Criteria:

* • Abnormal heart rate (\< 90/min or \< 160 per min )

  * Comfortable tachypnea ( RR \> 60/min without other manifestations of respiratory distress)
  * Abnormal heart sounds (muffled, accentuated, single )
  * Abnormal precordial activity
  * Murmur: ( ≥ grade 3 intenisty, holosystolic timing, maximum intensity at upper left sternal border or with upright positing, diastolic murmur, harsh or blowing quality )
  * Abnormal oxygen saturation \<90% in any extremity Oxygen saturation gradient \> 3% difference in extremities.
  * Blood pressure gradient \>10 mmHg higher in arms \>10 mmHg lower in legs
  * Abnormal femoral pulses
  * Weakened pulses
  * Absent pulses
  * Hepatomegaly
  * Family history of cardiac disease

Exclusion Criteria:

* Newborns with disorders affecting the heart as anemia, septicemia, respiratory disorders as respiratory distress syndrome, pneumonia, hypoplastic lung, renal impairment, hypertension, metabolic disease, syndromatic CHF
The New Combined PET-MR System NextGen PET-MR With Syngo MR XA80A: Evaluation of Diagnostic Image Quality and Usability (Software and Hardware) in the Clinical Setting.

This clinical investigation is used to evaluate the novel PET-MR scanner and it is a clinical investigation under MDR.

The focus is on the evaluation of the diagnostic image quality in a clinical setting, considering the speed of the examination and the new functionalities to minimize the patient's lying times. Based on the assessment, the defined protocols and measurement sequences are further improved as necessary to optimize the clinical value of the sequences and user interface components.


Eligibility Criteria:
Inclusion Criteria:

* Adult test subjects for whom a PET-MR examination is indicated and will be performed, or
* Test subjects for whom a PET-CT examination is indicated and will be performed
* Test subjects of legal age who have given their written informed consent to participate in the clinical investigation
* Written consent of the test subject to be informed in the event of suspected clinically relevant incidental findings
* Written consent to the disclosure of a clinically relevant incidental finding to a subsequent physician (release from the duty of confidentiality)
* The test subject´s written consent that the recorded image data may be made available to Siemens Healthcare A/S in pseudonymized form
* Test subjects whose weight does not exceed the permissible weight limit of the patient table (200 kg).

Exclusion Criteria:

* Metal in and on the body that causes stress to the test subject during an examination in the FoV of the combined PET-MR system
* All pacemakers and other implants
* Pregnancy: The exclusion of test subjects of childbearing potential is carried out based on a positive pregnancy test
* Test subjects who indicate an increased sensitivity to loud noises
* Test subjects who are incapable of giving consent.
Evaluation of Decision Capacity of ICU Patients Under Sedatives. A Prospective Observational Multicenter Study.

This prospective observational multicenter study is intended to investigate the impact of sedatives on the decision capacity of intensive care units patients.

Medicine has recently turned from paternalism to patient-centered decisions giving them back autonomy to determine their own treatments and end-of-life directives. Main prerequisite is patient's competence to fully understand information given from medical staff, integrate it and resituate comprehensive willing.

Informed decision-making necessitates patient's ability to appropriately communicate and interact with its environment. Intensive care unit (ICU) patients are often intubated -rendering oral communication impossible- and get sedated with various medications (hypnotics and opioids). Despite an apparently appropriate communication, some of them are confused. Confusion is regularly under diagnosed in ICU settings and necessitates specific tools to be detected, such as CAM-ICU (Confusion Assessment Method in ICU). While not confused, a patient might lack decision-making capacity, meaning that despite obvious communication, more elaborated cognitive function remains uncertain and often inappropriate. Decision-making capacity can be evaluated with dedicated scores such as the Johns Hopkins adapted cognitive examination (ACE). This score has recently been formally translated into French.

The influence of sedatives on decision-making capacity remains unknown to date. This prospective observational multicentre study is intended to investigate the impact of sedatives on the decision-making capacity of ICU patients. Furthermore, each sub-score of the ACE (orientation, language, registration, attention and calculation, and recall) will be investigated according to sedatives types. Patients' decision-making capacity will be clinically assessed by physician, resident and nurse in charge, blindly of ACE result.

Eligibility Criteria:
Inclusion Criteria:

* Mechanically ventilated patient (intubation or tracheotomy)
* Not delirious (negative CAM ICU)
* Calm and alert (RASS -1 to +1) since at least 12 hours and less than 72 hours
* Receiving sedatives and/or analgesics and/or medications interfering with neurological functions
* Adult patients with social security coverage

Exclusion Criteria:

* Brain injured patients (traumatic brain injury, ischemic or hemorrhagic stroke, sub-arachnoid hemorrhage, intra-parenchymal bleeding, hypoxic post cardiac arrest)
* Known cognitive disorders (MMSE \< 20)
* Neurodegenerative disease
* Pregnant woman
* Protocol refusal by the patient or closest next-of-kin
Intraoperative Volume Management and QT Interval

QT interval changes is measured during all phases of the operation. The protocol is focusing at intraoperative bleeding events and is also observing QT interval changes during anesthetic and operative procedures.

Prolongation of the QT interval is associated with functional torsade de points, re-entry, and sudden death (see reference). Variations of QT-interval caused by changes in the volume status of the patient during an operation remained unclear. QT interval changes will be monitored during the surgery with the focus of the influence of sudden blood loss, volume substitution by crystalloids, blood and blood products. The effect of surgical procedures on the QT-interval (e.g. clamping of kidney artery) will be observed as well as the association of intra-operative QT-interval alterations with postoperative complications.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists physical status classification 2 - 3
* patients after consent

Exclusion Criteria:

* Children,
* pregnant women,
* patients not able to consent
A Study of Azithromycin in HIV-Infected Patients

To assess the dose proportionality of azithromycin concentrations and toleration when delivered in tablet formulation to HIV-infected patients.

The need exists to further assess the antibacterial agent azithromycin at differing doses in an HIV-infected population.

The need exists to further assess the antibacterial agent azithromycin at differing doses in an HIV-infected population.

Patients are randomized to receive azithromycin at 1 of 2 doses in a two-treatment, two-period, cross-over study. Dosing visits are separated by at least 14-day wash-out periods.

Eligibility Criteria:
Inclusion Criteria

Patients must have:

* HIV seropositivity.
* CD4 count \<= 500 cells/mm3.
* NO active AIDS opportunistic infection.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

* Other active intercurrent illness.
* Any condition possibly affecting drug absorption (e.g., ulcers, gastrectomy, HIV-associated enteropathies.
* Signs or symptoms of severe illness that would preclude study participation.
* Known allergies to macrolide antibiotics.

Patients with the following prior condition are excluded:

Clinically important change in baseline status within 4 weeks prior to study entry.

Prior Medication:

Excluded:

* Investigational drugs including treatment IND drugs within 4 weeks prior to study entry.

Known drug or alcohol dependence.
Accuracy of a Rapid Diagnostic Test for Cutaneous Leishmaniasis in Morocco

The aim of this study is to estimate the accuracy of CL Detect Rapid Test™ compared to a composite reference standard test (Direct examination of skin smears + PCR test) in patients with clinically suspected Cutaneous Leishmaniasis disease in Morocco.

Study participants are recruited in nine health centers located in fourthree CL endemic provinces. The RDT under evaluation (index test) is the CL Detect™ Rapid Test (InBios, USA); a membrane-based amastigote antigen (peroxidoxin) detection test. The reference standard consists of two tests: direct examination of skin smears and PCR. For each patient, the health professional takes one dental broach sample and four skin smear samples from a single lesion. The dental broach sample is used for the RDT, which is done once. The skin smear samples are sent to provincial laboratories for microscopy testing and to reference laboratories in Morocco and Belgium for PCR testing by ITS1 PCR, Hsp70 genotyping and parasite load determination. Readers of index and reference tests do not have access to clinical information or any other test results. The results of the test under evaluation (RDT) and the molecular tests (PCR) are not communicated to the patient or her/his physician, as case management has to follow current clinical guidelines.

Eligibility Criteria:
Inclusion Criteria:

* Participants with suspected Cutaneous Leishmaniasis wound(s) in apparently healthy state
* Who is able to learn the Information sheet and sign the Informed consent form by them selves or by their parents with the presence or not of a witness (for illiterate people)
* Who satisfy the following criteria :

  * with an ulcerative lesion in any accessible part of the body to perform the dental broach and the scraping.
  * Just one ulcerative lesion by patient could be selected (The newest and the less infected)
  * Lesion should be less than 04 months of age

Exclusion Criteria:

* Patients with only nodular, papular, macular or nodulo-papular suspected CL forms
* Patients with ulcerative lesions with a suspected bacteria origin which could disappear after a short course of antibiotic treatment.
* Patients who already received during the last two months, prior to signing the consent, a physical treatment (e.g. cryotherapy, thermotherapy, Laser) or a traditional treatment (e.g. burn, acide, traditional scraping)
* Patients presenting other disease with the need to take anti-parasite treatments
* Patient with a acute or chronic disease needing hospitalization
* Patient who already received antimoniate treatment incomplete or complete duration and dose against CL
* Any situation that could engage the security of the patient or of the health professional (e.g. People with a psychiatric trouble or a mental handicap )
* For children less than 12 years old, the decision of participation is mainly based on the condition that their parents are able to learn and understand the information sheet and sign the informed consent form
Molecular Imaging Assessment of ACL Viability

The objective of this study is to answer the following questions:

1. Does the appearance of the reconstructed anterior cruciate ligament (ACL) vary in appearance on PET/MRI depending on graft type and time after surgery?
2. What is the appearance of the native ACL on Positron Emission Tomography/Magnetic Resonance Imaging (PET/MRI)?

This Phase I feasibility trial will evaluate knee injuries utilizing a standard of care non-contrast 3 Tesla (T) MRI. In addition, knee injuries will be assessed with a low dose (1/5 of the dose given for standard of care PET scans) fluorodeoxyglucose (FDG) PET research scan with CEST sequences. Patients enrolled in this study will include both those with and without a history of ACL repair; however, patients receiving the standard of care MRI will not be currently suspected of having an ACL injury based on physical examination and history.

Patients with and without a history of ACL reconstruction will undergo a low dose FDG PET scan in the same setting as their MRI. The PET examination will be performed such that the early phase of imaging is performed prior to the MRI and the delayed phase is completed immediately following the MRI. This dual-phase scanning will allow for both assessment of the vascularity of the graft as well as its metabolic activity.

Patients will be asked to provide study personnel with authorization to their medical records regarding the outcome of the knee graft. This authorization will be provided for 10 years from date of signed consent.

Comparisons of the finding in normal and reconstructed ligaments as well as between graft types based on time from reconstruction will demonstrate the feasibility of this imaging technique and allow for generation of an imaging based hypothesis that will provide metabolic activity of the graft in a post-operative knee.

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients between 18 and 60 years of age.
* Patients scheduled for a standard of care MRI at OSU.

Exclusion Criteria:

* Patients with a suspected ACL injury.
* Patients who are pregnant or lactating.
* Patients who are prisoners.
* Patients who are unable to provide consent.
* Patient with significant renal insufficiency, i.e. an estimated glomerular filtration rate (eGFR) less than 30 mL/min/1.73m2.
* Patients who exhibit noticeable anxiety and/or claustrophobia or who exhibit sever vertigo when they are moved into the MR.
* Subjects with any type of bioimplant activated by mechanical, electronic, or magnetic means (e.g., cochlear implants, pacemakers, neurostimulators, biostimulators, electronic infusion pumps, etc.).
* Subjects with any type of ferromagnetic bioimplant that could potentially be displaced or damaged.
* Subjects that have vascular or aneurysm clips, or metallic staples from a surgical procedure.
* Subjects with permanent tattoo eye liner (may contain metallic coloring).
* Subjects that may have shrapnel imbedded in their bodies, such as from war wounds, metal workers and machinists (metallic fragments in or near eyes), severe auto accident victims.