cyrilzakka/clinical-trials huggingface dataset:
Emergency Stroke Unit for Acute Cerebrovascular Events ( ESU-ACE-C )

To compare the prognosis of patients with hyperacute ischemic stroke (who arrive at the emergency department within 4.5 hours of symptom onset) managed in a standard stroke unit adherent to guidelines versus managed in Emergency Stroke Unit (a new stroke unit based on low-field magnetic resonance imaging).

The first MRI machines in the 1970s and 1980s were low-field due to technological limitations. As technology advanced, the focus shifted to higher field strengths to achieve better image resolution and faster scan times. Recently, there has been renewed interest in low-field MRI due to advancements in hardware and software, making them more viable for specific clinical applications, including acute stroke. Prompt and accurate imaging is crucial for diagnosing ischemic stroke and determining the appropriate treatment (e.g., thrombolysis or thrombectomy). Research has demonstrated that low-field MRI can effectively detect acute ischemic changes and distinguish between ischemic and hemorrhagic stroke. By providing accessible, cost-effective, and safe imaging, it can facilitate timely and accurate treatment, particularly in settings where high-field MRI is not readily available. This prospective, multicenter, week-wise randomized controlled trial will compare the prognosis of patients with hyperacute ischemic stroke (who arrive at the emergency department within 4.5 hours of symptom onset) managed in a standard stroke unit adherent to guidelines versus managed in Emergency Stroke Unit (a new stroke unit based on low-field magnetic resonance imaging).

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years;
2. Patients who arrive at the emergency department within 4.5 hours of symptom onset\* (\*Symptom onset is defined by the "last seen normal" principle);
3. Presenting with ischemic stroke symptoms;
4. Pre-stroke mRS score 0-1;
5. Baseline NIHSS score ≥ 5;
6. Eligible for rt-PA/TNK thrombolysis;
7. Informed consent signed.

Exclusion Criteria:

1. Baseline NIHSS score \< 5;
2. Unable to undergo MRI because of claustrophobia;
3. Patients with cardiac pacemaker/brain pacemaker/insulin pump implantation;
4. Definite contraindication for rt-PA/TNK thrombolysis;
5. Patients with postictal hemiparesis (Todd's paralysis) or those with concomitant neurological/psychiatric conditions who are unable or unwilling to cooperate;
6. Pregnant women, nursing mothers, or reluctance to use effective contraceptive measures during the period of trial;
7. Participation in other interventional randomized clinical trials within 3 months before enrollment;
8. Patients deemed unsuitable for participation in this trial by the investigator or those for whom participation in this trial may result in greater risks.
Evaluation of the Contribution of NODDI Protocol Tractography in Brain Tumor Surgery

The objective of this study is to evaluate to what extent the capacity of the NODDI model can allow, in case of Malignant brain tumor patients with vasogenic edema, the elaboration of a reliable cerebral functional mapping in accordance with the data of direct electrical stimulation (DES) which is today the reference tool.

the patient's participation in this study implies an additional visit during which an MRI examination without injection of contrast medium will be performed, lasting approximately 40 minutes (including installation and de-installation).

This is a single-center, prospective, open-label study of neurosurgical patients.

Compared to their usual management, the participation of the patient in this study implies an additional visit during which an MRI examination without injection of contrast product will be performed, lasting approximately 40 minutes (including installation and de-installation).

The operative time, surgical procedures and postoperative follow-up are not modified in this study

Eligibility Criteria:
Inclusion Criteria:

* Patient 18 years of age or older,
* Patient who has read and signed the consent form for participation in the study
* Patient requiring surgery for a malignant brain tumor with vasogenic edema
* Patient with an estimated life expectancy of more than 3 months.

Exclusion Criteria:

* Patient under legal protection, guardianship or trusteeship
* Patient not affiliated to the French social security system
* Contraindication to MRI (patient with a pacemaker or cardiac defibrillator, implanted equipment activated by an electrical, magnetic or mechanical system, patient with hemostatic clips on intracerebral aneurysms or with orthopedic implants, claustrophobic patient)
* Psychiatric history
* Refusal to be informed of an abnormality detected during the MRI
* Pregnant or breastfeeding woman
Effectiveness of Physiotherapist's Communication Skills on Clinical Outcomes in Chronic Musculoskeletal Patients

The purpose of this study is to investigate the impact of the physiotherapist's communication on the clinical presentation of patients with chronic musculoskeletal pain.

The purpose of this study is to investigate the impact of the physiotherapist's communication on the clinical presentation of patients with chronic musculoskeletal pain. Sixty-nine (69) patients with chronic musculoskeletal pain in the cervical or lumbar spine, knee, or shoulder will participate. They will be randomly divided into three groups, each consisting of thirty-three (33) patients. One group (Experimental- Good communication skills) will watch the video in which physiotherapist will develop qualities of good communication while he explains about chronic musculoskeletal pain, the other group (Experimental- Poor communication skills ) will view the video in which the physiotherapist imparts information and explains chronic pain without enhancing his communication skills and lastly, the control group (control) that will not view any video.

Eligibility Criteria:
Inclusion Criteria:

* Participants should speak and understand the Greek language, as the questionnaires and the video will be in Greek
* Participants should experience pain in one of the following four different areas: cervical or lumbar spine, knee, or shoulder
* Pain of musculoskeletal origin
* Pain lasting more than 3 months, evident on most days of the week to be classified as chronic pain, with a pain intensity of at least 3/10 Numeric Pain Rating Scale.

Exclusion Criteria:

* Medication for neurological/psychiatric disorders
* Pain medication on the day agreed upon with the researcher, in order to minimize the potential influence of medication
* Undergoing surgery in the last six months
* Pregnancy or childbirth before 1 year
Interaction of Apelin and Angiotensin in the Human Forearm Circulation

The apelin-APJ system is a relatively new discovery. It has generated interest in part due to it's apparent ability to counteract the renin-angiotensin system, which is frequently overactive in many cardiovascular disease.

Angiotensin has a powerful ability to cause blood vessels constrict and reduces their diameter. One of the actions of apelin is to cause blood vessels to relax and the investigators specifically wish test the hypothesis that apelin will cause blood vessels constricted by angiotensin II to relax.


Eligibility Criteria:
Inclusion Criteria:

* \> 18 years old

Exclusion Criteria:

* Lack of informed consent
* Age \< 18 years,
* Current involvement in other research studies,
* Systolic blood pressure \>190 mmHg or \<100 mmHg
* Malignant arrhythmias
* Renal or hepatic failure
* Haemodynamically significant aortic stenosis
* Severe or significant co morbidity
* Women of childbearing potential.
* Any regular medication
* Previous history of any cardiovascular disease
Unequal Placental Sharing in Monochorionic Diamniotic Twins: an Observational Study

This is an observational study in 3 cohorts of monochorionic diamniotic (MCDA) twins. The aim of the study is to assess whether unequal placental sharing can be predicted in pregnancy and whether it is predictive of pregnancy outcome.

In all cohorts, serial ultrasound will be performed during pregnancy. MRI will be offered once during pregnancy. After delivery, placental examination will be performed.

In unselected MCDA twins, the investigators will assess the relationship between unequal placental sharing and the risk of fetal or neonatal loss. The investigators will also establish whether umbilical vein measurements or MRI can be used to predict placental sharing.

In cases complicated by twin-to-twin transfusion syndrome (TTTS), the investigators will look at the association between unequal placental sharing and intrauterine fetal demise after laser surgery.

In cases complicated by selective intra-uterine growth restriction (sIUGR), the the relationship between unequal placental sharing and the risk of fetal or neonatal loss and birth prior to 34 weeks will be assessed.

Furthermore, data on neurological outcome at 2 years of age in all cohorts will be collected.

Eligibility Criteria:
Inclusion Criteria:

* MCDA cohort

  * Ongoing monochorionic diamniotic twin pregnancy between 11 and 14 weeks, as determined by the crown rump length of the larger twin in spontaneous conceptions and by the date of insemination or embryonic age at replacement in pregnancies resulting from subfertility treatment
  * Women aged 18 years or more, who are able to consent
  * Written informed consent to participate in this study, forms being approved by the Ethical Committees
* TTTS cohort

  * Monochorionic diamniotic twin pregnancy, with gestational age defined in the first trimester as mentioned above
  * Complicated by TTTS according to the definition used in the Quintero staging of TTTS (DVP of donor \< 2 cm and DVP of receptor \> 8 cm before 20 weeks or \> 10 cm after 20 weeks
  * Undergoing laser surgery for TTTS
  * Women aged 18 years or more, who are able to consent
  * Written informed consent to participate in this study, forms being approved by the Ethical Committees
* sIUGR cohort

  * Monochorionic diamniotic twin pregnancy, with gestational age defined in the first trimester as mentioned above
  * Complicated by sIUGR defined as a discordance in EFW of ≥ 20%, with the percentage of discordance being calculated as (EFW larger twin - EFW smaller twin)/EFW larger twin x 100.
  * Women aged 18 years or more, who are able to consent
  * Written informed consent to participate in this study, forms being approved by the Ethical Committees

Exclusion Criteria:

* Age \< 18 years
* Inability to consent
T-cell-immunity During Standard Radiotherapy in Localised Prostate Cancer

Immunological effects of radiotherapy have been described before, but not evaluated in a time-dependant manner.

In order to identify a possible time frame for combination therapies, white blood cells are isolated of samples taken at different time points before during and after standard radiotherapy in patients with localised prostate cancer. The overall activity of the T-cell-system as well as tumor-specific T-cell-response are evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Localised prostate cancer (node negative)
* definitive radiotherapy
* informed consent

Exclusion Criteria:

* medication including steroids or immunosuppressants
Study of Peripheral Arterial Calcification

Aim of the work :

1. Using different calcification scoring systems to investigate the association between arterial calcification and clinical outcome following endovascular therapy

Peripheral arterial disease (PAD) is a worldwide health problem and its prevalence is increasing among aging population. Symptomatic PAD Is a major cause of major amputation with reduction of the functional capacity and quality of life . Arterial calcification is calcium crystallization deposits in the extracellular matrix of the intima and media . Medial calcification is usually associated with chronic kidney disease and diabetes mellitus, while intimal calcification comes usually as a part of atherosclerotic process . The relationship between calcification and PAD is well established . Arterial calcification is associated with increased risk of procedural failure and major amputation . Many calcium scoring systems have been proposed, including peripheral arterial calcium scoring scale (PACSS which highlights the pathologic location of calcification along with the length of the segment affected. The peripheral academic research consortium (PARC) suggested another calcium scoring scale that classified calcification into 4 major grades . The DEFENETIVE Ca++ have proposed another calcium severity scoring . Intravascular Ultrasound (IVUS) is highly sensitive to presence and location of atherosclerotic calcium .

The impact of intimal and medial vascular calcification on the safety and effectiveness of endovascular devices to treat symptomatic peripheral arterial disease (PAD) remains poorly defined warranting continued research to elaborate relationship between calcification and endovascular outcome.

Eligibility Criteria:
Inclusion Criteria:

1. patients with peripheral arterial disease
2. patients with disabling limb claudication
3. patients with rest pain
4. patients with minor tissue loss
5. patients admitted to vascular surgery department for endovascular intervention of a denovo lower limb arterial lesion

Exclusion Criteria:

* 1)Patient's age less than 50. 2)Patients with major tissue loss \[ Rutherford category 6\] 3)Patients with recurrent lesion after previous intervention. 4)Patients with double level arterial lesion. 5) Patients refusing to participate in this study
Efficacy of Three Online Well-Being Programs to Improve Work-Related Outcomes

Participants will be randomly assigned between three well-being programs, and assessed with questionnaires before and after the 8-week program, as well as 1-month after the end of the program.

Participants will be randomly assigned between three different well-being programs, with each program lasting 8-weeks and taking place on a simplified research version of the Happify platform. Well-being programs include the unchanged Happify platform, a version of the Happify platform that is designed to engage with specific activities but does not aim to promote positive emotion or reduce negative emotion (i.e., Placebo condition), and a version of the Happify platform that encourages thinking about well-being through quizzes and polls without providing any instructions for promotion (i.e., Wait-list Control). Participants will be asked to complete questionnaires before and after the 8-week program, as well as a 1-month follow-up questionnaire after the program is complete, at which point study participation will end.

Eligibility Criteria:
Inclusion Criteria:

* No prior experience on the Happify platform (new user registration)
* Full-time employment

Exclusion Criteria:

* None
Dalacin-T Gel Post Approval Study

To investigate, in a comparison vs. Acuatim cream (nadifloxacin cream), the efficacy and safety of Dalacin T Gel (clindamycin phosphate gel) as a therapeutic medication for acne vulgaris in acne vulgaris patients, including children ages 13 and up, in order to clarify the clinical positioning of Dalacin T Gel.


Eligibility Criteria:
Inclusion Criteria:

* Acne vulgaris patients found by a investigator to have at least 10 inflammatory lesions (papules, pustules) on a portion of either a cheeks or the forehead, with an inflammation severity of moderate or worse.

Exclusion Criteria:

* Patients with, for example, acne elastosis, steroidal acne, necrotizing acne, or occupational acne.
Hemodynamic Optimization of Cerebral Perfusion After Endovascular Therapy in Patients With Acute Ischemic Stroke

Mechanical thrombectomy is a very effective treatment in patients who have suffered an acute ischemic stroke associated with intracranial large vessel occlusion. However, less than half of the patients achieve functional independence despite treatment. The optimization of blood pressure after mechanical thrombectomy based on the degree of recanalization achieved at the end of the procedure could improve the perfusion of the ischemic brain tissue thanks to the improvement of blood circulation provided by collateral circulation. For this, authorized hypotensive or hypertensive drugs will be used. Moreover, this individualized treatment would allow to decrease reperfusion injury and therefore decrease the risk of intracerebral bleeding complications and cerebral edema. Therefore, we designed a clinical trial in which the standard management of blood pressure after mechanical thrombectomy will be compared with a specific protocol in which blood pressure targets are applied according to the degree of recanalization obtained during the thrombectomy procedure. The beneficial effect and risk reduction of this treatment will translate into a better short and long-term outcome


Eligibility Criteria:
Inclusion Criteria:

* Patients with acute ischemic stroke and large intracranial vessel occlusion within 24 hours after the onset of symptoms in whom mechanical thrombectomy has been performed.
* Successful recanalization, defined as a TICI score of 2b, 2c, or 3.
* Previous score on the modified Rankin scale (mRS) of 0, 1, or 2.
* The patient or her legal representative gives informed written or verbal consent

Exclusion Criteria:

* ASPECTS score \<6
* Vertebral, basilar, A2, P2 and M3-4 occlusion
* History of intracerebral hemorrhage
* Pregnant or breastfeeding patient
* Patient with congestive heart failure or recent/unstable coronary artery disease (\<3 months)
* Dissection of aorta, cervical or cerebral or unruptured aortic / cerebral aneurysm or known arteriovenous malformation
* Any bleeding visible on baseline CT
* History of ventricular arrhythmias
* Use of MAO inhibitors
* Inclusion in other clinical trials.
A Study of SHR6390 in Advanced Solid Tumor Patients

SHR6390 is a small molecular, oral potent, selective CDK4/6 inhibitor. The purpose of this study is to investigate the safety/tolerability and the pharmacokinetic profile of SHR6390 in Chinese advanced solid tumor patients by using a "3+3" dose escalation.Preliminary efficacy will be also investigated in this study.


Eligibility Criteria:
Inclusion Criteria:

* Pathologically confirmed solid tumor and failed from all standard treatment
* Eastern Cooperative Oncology Group (ECOG) performance status: 0-1
* Life expectancy ≥ 3 months
* Adequate function of major organs, meaning the following criteria should be met within 14 days before randomization:

  * Hemoglobin \> 110g/L
  * Neutrophils \> 2.0×10\^9/L
  * Platelets \> 100×10\^9/L
  * Total bilirubin \< 1.5×the upper limit of normal (ULN)
  * ALT and AST ≤ 1.5×ULN (≤ 5×ULN, if existing liver metastases)
  * Creatinine ≤ 1 ULN
  * Left ventricular ejection fraction (LVEF) ≥ 50%
  * QTcF(Fridericia correction) male≤450 ms, female≤470 ms
* Good compliance of patient by physician's judgement
* Signed and dated informed consent

Exclusion Criteria:

* Previously received therapy of anti-tumor agent targeting at CDK4/6
* Less than 3 weeks from the last cell-toxicity chemotherapy, less than 6 weeks from last mitomycin or nitrosamine therapy
* Less than 3 weeks from any other anti-tumor therapy (including targets therapy, immunotherapy or other approved therapy)
* Having joined in other clinical trials within 4 weeks
* Uncontrolled/untreated brain metastasis (well-controlled/well-treated brain metastasis by physician's judgement is allowed)
* existing abnormal CTCAE≥grade 2 resulted from previous treatment(except grade 2 alopecia)
* uncontrollable symptomatic pleural effusion or ascites or require clinical intervention
* require continous treatment by steroids
* Factors influencing the usage of oral administration (e.g. unable to swallow, chronic diarrhea and intestinal obstruction, etc.)
* existing uncontrollable hypokalemia or hypomagnesemia
* history of serious allergy events or known being allergy constitution
* active HBV or HCV infection (HBV virus≥10e4 copies/ml, HCV virus≥10e3 copies/ml)
* History of immunodeficiency, acquired or congenital immunodeficiency, history of organ transplantation
* history of cardiac dysfunction, include(1)angina (2)clinical significant arrythmia or require drug intervention (3)myocardial infarction (4)heart failure (5) other cardiac dysfunction (judged by the physician); any cardiac or nephric abnormal ≥grade 2 found in screening
* Female patients who are pregnancy, lactation or women who are of childbearing potential tested positive in baseline pregnancy test childbearing female who refuse to accept any contraception practice
* determined by the physician, any coexisting disease might lead to life threatening complications or avoid the patients from accomplishing the treatment(e.g serious hypertension, diabetes, thyroid dysfunction,etc.)
* history of neuropathy or dysphrenia, including epilepsy and dementia
Study Evaluating Bazedoxifene/Conjugated Estrogen Combinations in Symptoms Associated With Menopause

The purpose of this study is to determine whether bazedoxifene/conjugated estrogens combinations are effective in the treatment of moderate to severe vasomotor symptoms associated with menopause.


Eligibility Criteria:
Inclusion Criteria:

* Generally healthy, postmenopausal women, aged 40 to 64, with last natural menstrual period completed at lease 6 months ago
* Intact uterus
* Seeking treatment for hot flushes and experiencing 7 moderate to severe hot flushes per day or 50 per week

Exclusion Criteria:

* History of active presence of thrombophlebitis, thrombosis, thromboembolic disorders
* History of active presence of stroke, TIA, heart attack or ischemic heart disease
* History of melanoma, breast or any gynecologic cancer at any time; history of any other cancer within the past 5 years
A Safety and Efficacy Study of DRM02 in Subjects With Rosacea

The purpose of this study is to determine whether DRM02 is safe and effective in the treatment of rosacea when applied twice daily for 6 weeks.

This is a double-blind, randomized, vehicle controlled, study enrolling 30 subjects with rosacea and designed to assess the safety, tolerability, and preliminary efficacy of DRM02.

Safety will be assessed during the study, through adverse events, local skin responses, urinalysis, serum chemistry and hematology laboratory testing, physical examination and vital signs.

Preliminary efficacy will be assessed through inflammatory lesion counts, the Investigator's Global Evaluation (IGE) and the Rosacea Signs and Symptoms (RSS) scale.

Eligibility Criteria:
Inclusion Criteria:

* Male or female 18 to 70 years of age.
* Clinical diagnosis of rosacea with a score of 2 or 3 on the Investigator's Global Evaluation (IGE) of Rosacea scale and at least 15 and not more than 40 papules.
* Subjects willing to minimize external factors that might trigger rosacea flare-ups.
* Male or non-pregnant, non-lactating females.
* Signed informed consent.

Exclusion Criteria:

* Severe self-reported facial sensitivity.
* Severe sun sensitivity.
* Ocular-only, phymatous rosacea or steroid rosacea.
* Use of topical rosacea treatments in the 4 weeks prior to baseline.
* Use of systemic corticosteroids within the 4 weeks prior to baseline.
* Use of systemic antibiotics in the 4 weeks prior to baseline.
* Use of systemic retinoids for in the 6 months prior to baseline.
* Use of topical retinoids in the 3 months prior to baseline.
* Use of light- or laser-based rosacea treatments in the past 2 months prior to baseline.
* Cosmetic procedures within the 2 months prior to baseline.
* Use of topical anti-aging medications in the 2 weeks prior to baseline.
* Subjects who have poor skin condition within 5 cm of the treatment area.
* Subjects who are current drug or alcohol abusers; have a history of immunodeficiency or are a poor medical risk because of other systemic diseases or active uncontrolled infections.
* Subjects with an unstable medical condition or a medical condition not adequately controlled with standard medical therapy.
* Subjects who are actively participating in an experimental therapy study or who have received experimental therapy within 30 days.
* Subjects who have a clinically significant laboratory value at screening.