cyrilzakka/clinical-trials huggingface dataset:
STAND: iSchemic sTroke evAluated at Bed Side With ultrasouND

Ischemic strokes account for more than 80% of strokes. Ischemic strokes are caused by the occlusion of an intracranial artery by a thrombus, responsible for tissue ischemia related to a decrease in local cerebral blood flow (CBS). Thus, the management of patients with Ischemic strokes is based on the preservation of an area that maintains sufficient intracranial hemodynamics (IH) and achieves the fastest possible recanalization. The impact of the patient's position (supine or seated position) on the IH in the event of narrowing or occlusion of an artery is poorly assessed but may be of particular importance. In practice, variations in blood flow according to the positioning of the patient's body can be measured using a transcranial Doppler. It is a simple, non-invasive and painless examination that provides the patient's bed with data on the intracerebral hemodynamic profile of patients.

This study was implemented because there are no studies known to us that evaluate the effect of verticalization on intracerebral hemodynamics based on the presence of upstream arterial stenosis or occlusion and other multimodal evaluation data in transcranial Doppler.


Eligibility Criteria:
Inclusion criteria

* Patient over 18 years of age
* acute ischemic stroke or transient ischemic attack
* symptoms onset \< 48 hours
* Absence of homolateral or downstream intracranial stenosis or M1 occlusion
* Verticalization authorized by the referent clinician.
* Rankin's score before AIC/AIT ≤ 2
* Non-opposition to participation in the study

Criteria for inclusion of cases

- Carotid stenosis of more than 50% NASCET or an occlusion

Criteria for including witnesses - Absence of carotid stenosis greater than 50% NASCET or occlusion

Criteria for non-inclusion

- Disrupted vigilance
Evaluation of the GORE® EXCLUDER® Iliac Branch Endoprosthesis

The Iliac Branch Endoprosthesis (IBE) 12-04 study will be a prospective, nonrandomized, multicenter, single-arm evaluation designed to assess the safety and efficacy of the IBE Device in subjects with common iliac artery aneurysms (CIAA) or aorto-iliac aneurysms (AIA).


Eligibility Criteria:
Inclusion Criteria:

1. Common iliac aneurysm with or without concomitant abdominal aortic aneurysm
2. Adequate native anatomy to receive the EXCLUDER® and Iliac Branch Endoprostheses
3. An Informed Consent Form signed by Subject or legally authorized representative
4. Male or infertile female
5. Able to comply with protocol requirements including following-up
6. Life expectancy \> 2 years
7. Age \> 21 years
8. Surgical candidate

Exclusion Criteria:

1. Mycotic or ruptured aneurysm
2. Known concomitant thoracic aortic aneurysm which requires intervention
3. American Society of Anesthesiologists (ASA) Physical Status classification system class V (moribund patient not expected to live 24 hours with or without operation)
4. Renal insufficiency defined or patient undergoing dialysis
5. New York Heart Association (NYHA) Functional Classification class IV
6. Dissected, heavily calcified, or heavily thrombosed landing zone(s)
7. Tortuous or stenotic iliac and/or femoral arteries
8. Participating in another investigational device or drug study within 1 year of treatment
9. Systemic infection which may increase the risk of endovascular graft infection
10. Known degenerative connective tissue disease, e.g., Marfan or Ehler-Danlos Syndrome
11. Planned concomitant surgical procedure or major surgery within 30 days of treatment date
12. Known history of drug abuse
13. Known sensitivities or allergies to the device materials
Korean Post Marketing Surveillance for Comirnaty Injection (Bretovameran)

This study is to identify any problems and questions with respect to the safety of Comirnaty Injection (Bretovameran) during the post-marketing period.

All assessments are performed as part of normal clinical practice or standard practice guidelines for the subject population and healthcare provider specialty in the countries where this non-interventional study is being conducted.

This study is conducted under normal clinical practice in accordance with regulatory requirements. Therefore, the inclusion and exclusion criteria for study subjects are related to indications and contraindications outlined in the local product document. This study will not provide or make recommendations on any vaccine use. The vaccines are all given as part of the standard of care. All enrolled subjects have to meet the general prescription criteria for Comirnaty Injection (Bretovameran) according to the local product document and have to be enrolled at the doctor's discretion.

This is an open-label, non-comparative, non-interventional, prospective, and multi-center study conducted in Korean health care centers by accredited physicians (investigator). The study population is Korean subjects who are scheduled for COVID-19 vaccination. Comirnaty Injection (Bretovameran) will be administered according to the "Dosage and Administration" of the authorized label. There is no visit or activity mandated by this study. The investigator will collect data from the subject's medical records and diary and record data on each subject's case report form (CRF).

Eligibility Criteria:
Inclusion Criteria:

* Korean subjects who are eligible for administration of Comirnaty Injection according to the locally authorized label
* Subjects with evidence of a personally signed and dated informed consent/assent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study

Exclusion Criteria:

* Subjects who involved in the contraindications of use indicated in the locally authorized label
* Subjects with a history of hypersensitivity to any ingredients of this product or this product
* Any subjects (or a legally acceptable representative) who does not agree that Pfizer and companies working with Pfizer use his/her information
CCSH (Compassion-Centered Spiritual Health) for Teams

Emory Spiritual Health has developed a Compassion-Centered Spiritual Health group-based intervention, called CCSH Interventions for Teams, and are enrolling staff and providers into the groups in this randomized study design. The groups will meet once every other week for 60 minutes for 8 weeks (4 sessions total).

The investigators will evaluate the feasibility and acceptability of this novel team-based intervention that includes mindfulness and compassion-based approaches with mixed-role oncology teams. Employees (n = 80; nurses, advanced practice providers (APPs), physicians, staff) working at an NCI- designated Comprehensive Cancer Center will be randomized by team (8-12 employees/group) to Compassion Centered Spiritual Health Team Intervention (CCSH-TI) or TAU (Treatment as Usual) group. The research objective is to evaluate the feasibility and acceptability of CCSH-TI, and to develop and validate a novel, low-burden ambulatory assessment "toolkit" to improve the measurement of psychological safety and burnout.

Current interventions to reduce provider burnout are only minimally effective. To overcome the barriers to achieving success in burnout prevention interventions, the investigators propose Compassion Centered Spiritual Health Team Intervention (CCSH-TI), a 4-session intervention delivered by healthcare chaplains to mixed-role interprofessional teams that includes mindfulness and compassion-based approaches to bolster resilience, compassion for self and others, and psychological safety. The research team will conduct a mixed-method feasibility and acceptability study of CCSH-TI with mixed-role oncology teams. Employees (n = 80; nurses, advanced practice providers (APPs), physicians, staff) working at an NCI-designated Comprehensive Cancer Center will be randomized by team (8-12 employees/group) to CCSH-TI or to TAU (Treatment as Usual) group, who has access to all well-being resources and activities available to them as employees. Self-report surveys and focus group discussions will be used to evaluate the feasibility and acceptability of CCSH-TI. The investigators will also collect self-report surveys, ecological momentary assessments (EMA), and the electronically activated recorder (EAR) data at 3 timepoints (before CCSH-TI (T1), immediately after completion of CCSH-TI (T2), and 12-weeks after completion (LT), and characterize data completion to evaluate the feasibility of data collection methods for a future randomized control trial. Informed consent will be obtained from study participants in-person. The duration of the study will be 22-23 weeks (from consent to completion of data collection).

Eligibility Criteria:
Inclusion Criteria:

* Full-time employees working in oncology teams at Winship Cancer Institute;
* Employees working in intensive care at Emory University St. Joseph hospital.

Exclusion Criteria:

* Less than 18 years old
VX-445/TEZ/IVA Expanded Access Program for Cystic Fibrosis (CF) Patients Heterozygous for F508del Mutation and a Minimal Function Mutation (F/MF Genotypes)

The purpose of this program is to provide elexacaftor(ELX, VX-445)/tezacaftor(TEZ)/ivacaftor(IVA) combination therapy to CF patients in critical need who are 12 years of age and older, heterozygous for F508del and a minimal function (MF) mutation in response to unsolicited physician requests.


Eligibility Criteria:
Inclusion Criteria:

1. Patients who have F/MF genotypes AND who meet at least 1 of the following criteria:

* The percent predicted forced expiratory volume in 1 second (ppFEV1) is \<40 for a minimum of 2 months before the date of the request, OR
* Documentation of being active on a lung transplant waiting list or documentation of being evaluated for lung transplantation, but deemed unsuitable because of contraindications

Exclusion Criteria:

1. Patients with severe hepatic impairment (Child-Pugh Class C)
2. History of any other comorbidity that, in the opinion of the treating physician, might pose undue risk in administering ELX/TEZ/IVA to the patient
3. Pregnancy

Other protocol defined Inclusion/Exclusion criteria may apply
The Preventive Effects of Neurodynamic Mobilisation

In the study, 34 healthy sedentary male volunteers were randomly divided into two groups as NM (n = 17) and SHAM-NM (n = 17). After the initial evaluation of the individuals, femoral nerve NM and placebo NM techniques were administered three sets a day with ten repetitions for three days a week for three weeks. Three days after the end of the applications, the second evaluations were made and the DOMS creation protocol for the quadriceps femoris (QF) muscle was initiated. In order to trigger DOMS in individuals, 30 sets and 10 repetitions of eccentric knee extension (35°-95° flexion angles, 30°/sec speed) were performed on the dominant lower extremity with an isokinetic dynamometer. Baseline evaluations were repeated immediately after the DOMS protocol, and at hours 24, 48, and 72. During evaluations, muscle damage (serum creatine kinase (CK), lactate dehydrogenase (LDH), and inflammation (interleukin-6 (IL-6), tumor necrosis factor-alpha) biomarkers, pain (activity), pressure pain threshold, and performance (one-leg jump, vertical jump) parameters were measured.

The aim of this study was to investigate the effects of neurodynamic mobilization (NM) technique on muscle damage and inflammation biomarkers, and pain, pressure pain threshold, and functional status in delayed onset muscle soreness (DOMS). In the study, 34 healthy sedentary male volunteers were randomly divided into two groups as NM (n = 17) and SHAM-NM (n = 17). After the initial evaluation of the individuals, femoral nerve NM and placebo NM techniques were administered three sets a day with ten repetitions for three days a week for three weeks. Three days after the end of the applications, the second evaluations were made and the DOMS creation protocol for the quadriceps femoris (QF) muscle was initiated. In order to trigger DOMS in individuals, 30 sets and 10 repetitions of eccentric knee extension (35°-95° flexion angles, 30°/sec speed) were performed on the dominant lower extremity with an isokinetic dynamometer. Baseline evaluations were repeated immediately after the DOMS protocol, and at hours 24, 48, and 72. During evaluations, muscle damage (serum creatine kinase (CK), lactate dehydrogenase (LDH), and inflammation (interleukin-6 (IL-6), tumor necrosis factor-alpha) biomarkers, pain (activity), pressure pain threshold, and performance (one-leg jump, vertical jump) parameters were measured.

Eligibility Criteria:
Inclusion Criteria:

* Being in the age range of 20-32 years.
* Being male (Because gender difference in the magnitude of eccentric exercise-induced muscle damage might exist as shown in previous studies, only men were recruited in the present study.)
* Being inactive according to activity guidelines published by the American College of Sports Medicine (less than 30 minutes of moderate physical activity as five times a week).

Exclusion Criteria:

* Absence of DOMS symptoms,
* History of vascular disease,
* Recent injury or surgery to their lower extremity,
* Neurological impairments and regular use of pain and inflammation medications.
Arabic PRO Measures for Head and Neck Cancer Radiotherapy.

The goal of Arabic patient-reported outcome measures during radiotherapy for head and neck cancer is to test the patient-reported outcome measure (PROM) tools. PROM tools are not validated cross-culturally in Arabic-speaking patient populations, which limits their use in our clinical setting. Validation of these PROM tools will allow clinicians to identify the concerns related to our patient population and measure the outcome of our interventions. Main objectives are:

* To further validate (cross-culture) the PROM instruments related to head and neck cancer (HNC) in Arabic patients.
* To investigate the prevalence and severity of the patient-reported concerns and their relevance with demographics and clinical characteristics.

The participants will be given tasks to complete 6 tools survey before, during, and after radiotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Adults aged 18 or above and who is planned for receiving and who is currently receiving and who had already received radiotherapy for the HNC at King Saud University Medical City.

Exclusion Criteria:

* Individuals who are less than 18 years, presence of debilitating disease (e.g. heart failure) or who lack the capacity to read, understand and sign the informed consent and those.
Pharmacokinetics of a Single 14C-labeled Dose of Risedronate or Alendronate Followed by Once-a-week Unlabeled Oral Dose

The primary objective of this study is to compare the urinary excretion of 14C-labeled risedronate and alendronate over 28 days.


Eligibility Criteria:
Inclusion Criteria:

* have medical history documentation verifying postmenopausal status of at least 2 years (natural or surgical). If not documented, confirmation will be required using estradiol \< 20 pg/mL and follicle stimulating hormone (FSH) \> 40 IU/mL;
* have osteopenia or osteoporosis (\< 1.002 g/cm2 Lunar or \< 0.882 g/cm2 Hologic) as determined by DXA of the lumbar spine (AP or PA view, L1-L4). This corresponds to a T-score of approximately \< -1.5.

Exclusion Criteria:

* any clinically significant out-of-range laboratory values and vital signs,
* a clinically significant cardiovascular, hepatic, renal, or parathyroid disease, in the opinion of the Investigator
* a known hypersensitivity to bisphosphonates
Clinical Trial to Evaluate the Safety and Effectiveness of a Canaloplasty Device in Subjects With Open-Angle Glaucoma

Clinical Trial to Evaluate the Safety and Effectiveness of a Canaloplasty Device in Subjects with Open-Angle Glaucoma


Eligibility Criteria:
Inclusion Criteria:

1. Subjects qualifying for cataract surgery
2. Subjects with diagnosis of open-angle glaucoma in at least one eye with unmedicated IOP of 22-34 mmHg.

Exclusion Criteria:

1. Patients who cannot be washed-out of IOP-lowering medications.
The Effects of Circadian Gene on Sleep and Associated Symptoms in Breast Cancer Patients Under Chemotherapy

The purpose of this study is the evaluation of effect of circadian gene on sleep and other symptoms in breast cancer patients under chemotherapy.

In this study, the investigators are going to examine the effect of genetic polymorphism on sleep, anxiety, depression and other cancer-related symptoms in patients with breast cancer who have started chemotherapy after surgery. No intervention was intended and blood sample was taken with other routine laboratory tests.

Eligibility Criteria:
Inclusion Criteria:

* Age: 18-70
* Patient with breast cancer without metastasis
* Patient received cancer surgery and medically stable
* Patient will undergo chemotherapy for the first time in life
* Patient have signed on the informed consent, and well understood the objective and procedure of this study

Exclusion Criteria:

* Patient received chemotherapy or radiotherapy
* Patient had another cancer before
* Patient have metastasis
* Patient with severe medical condition
* Patient had taken psychiatric medication more than 1 month in life
* Patient worked the night shift for more than 1 month in 6 months
The Role of Inflammation in Myocardial Infarction

The aim of this research is to study the prognostic role of a selected combination of cytokines and adipokines in patients with myocardial infarction, as well as to determine their role in the development of adverse cardiac remodeling.

After an acute myocardial infarction (AMI) the inflammatory response seems to have a central role and is connected to major adverse outcomes such as ischemia-reperfusion injury, adverse cardiac remodeling, infarct size, and poor prognosis. The concept of monitoring inflammatory markers as predictors of post-myocardial prognosis is gaining more momentum. Finding the appropriate inflammatory biomarker that would serve as a prognostic marker after an AMI and could stratify the risk for adverse outcomes, could be extremely useful.

INFINITY is a multi-center, prospective, observational cohort study, aiming to assess the complex role of inflammation in the post-AMI period. The study plans to include 120 consecutive patients above 18 years old admitted to the four centers participating in the study.

A panel of inflammatory cytokines and adipokines will be recorded. A venous blood sample will be collected on patient admission (H0), 6-12 hours after admission (H6-12), 24-48 hours after admission (H24-48), and at the 30-day visit (D30). Blood will be collected for routine laboratory tests, as well as to measure the levels of the cytokines IL-6, IL-10, IL-18, IL-17, and the adipokines leptin, apelin, and chemerin.

60 carefully selected patients will consist of the control group. The control group will consist of individuals to whom the obstructive coronary artery disease would be ruled out either by invasive or non-invasive coronary angiography or by myocardium perfusion SPECT or stress echocardiography. The patient and control group will be matched at baseline by equating certain clinical characteristics of interest between the exposed and unexposed groups.

The study will test the hypothesis that circulating plasma levels of the above inflammatory biomarkers reflect different clinical manifestations of coronary artery disease and correlate with coronary anatomy, the severity of coronary artery disease, and the prognosis in a 6-month follow-up period. Finally, will investigate whether the integration of the above inflammatory biomarkers into the already established prognostic risk stratification model, GRACE score, could further improve its predictive power.

Eligibility Criteria:
Inclusion Criteria:

1. ACS (ST-ACS, NSTE-ACS, UA) referred for coronary angiography
2. Above 18 years old
3. Consent form obtained

Exclusion Criteria:

1. Chronic Renal Failure (CRF) stage IV (e GFR \< 29 ml/min or creatinine \> 2 mg/dl)
2. Chronic Liver Disease (CLD) (ALT \> 2 times upper normal limit)
3. Chronic Inflammation and/or autoimmune diseases
4. Active Ca
5. Recent CVA (less than 1 month)
6. Recent (within 2 weeks) use of glucocorticoid drugs or immunosuppressive agents
7. Acute or chronic infection, major surgery, or trauma in the last month
8. Previous heart transplantation
9. Poor life expectancy
10. Cardiogenic shock
11. Cardiac arrest
Functional Navigation in Surgery of Cerebral Tumors and Vascular Malformations

The purpose of the study is to assess accuracy, advantages of functional neuronavigation and calculate safe distance from motor areas to brain tumors and vascular malformations in image-guided surgery.

Functional images (functional magnetic resonance imaging (fMRI), transcranial magnetic stimulation (TMS), tractography) loaded in neuronavigation are called functional navigation. It is usually combined with anatomical data and allows to display eloquent brain areas. Currently there are plenty of studies concerning possibilities of it's use. In our research we plan to confirm this data and to supplement them with calculating a safe distance from motor areas to various mass lesions in preoperative scans where neurological deficits is not likely to appear after surgery. In case of success this data can be a foundation for further researches specifying indications for use of intraoperative neuromonitoring and possibility of it's replacement with functional navigation in some cases.

The purpose of the study is to assess accuracy, advantages of functional neuronavigation and calculate safe distance from motor areas to brain tumors and vascular malformations in image-guided surgery. For each patient a surgeon intraoperatively will assess locations of motor cortex and corticospinal tract found with direct cortical and subcortical stimulation and capture them. After surgery he will compare this data with functional preoperative scans and virtual motor centers constructed based on tractography. Influence of various factors on precision of functional navigation will be studied and safe distance between motor brain areas and mass lesion borders will be calculated.

Eligibility Criteria:
Inclusion Criteria:

* all intracranial tumors
* arteriovenous malformations
* cavernous malformations
* supratentorial localization
* newly diagnosed
* age 18-79 years
* unaltered consciousness
* error of patient registration in neuronavigation no more than 2 mm
* possibility to perform "positive mapping" strategy

Exclusion Criteria:

* contraindications to magnetic resonance imaging or transcranial magnetic stimulation
* inability to build tractography in neuronavigation
* predicting of intraoperative brain shift 6 mm and more without possibility to correct it
* real intraoperative brain shift 6 mm and more without possibility to correct it
* previously performed brain radiotherapy
* pregnancy
* breast feeding