cyrilzakka/clinical-trials huggingface dataset:
Prevalence and Risk Factors of Pulmonary Hypertension in Patients with Myeloproliferative Neoplasms in Assiut University Hospital.

This study will evaluate the MPNs patients for the presence of PH by using a non invasive method ( Transthoracic echocardiography (TTE )) and correlate the clinical and laboratory data of these patients with development of PH aiming to identify risk factors for PH and parameters that can predict PH in MPNs patients and thus,identifying MPNs patients who require close monitoring \& screening for PH ,hoping that early detection and management of PH in MPNs patients can improve morbidity, prognosis and survival in those patients.

Pulmonary hypertension (PH) is a syndrome characterized by marked remodeling of the pulmonary vasculature and a progressive increase in the pulmonary vascular load. PH is a serious complex disorder that associated with high morbidity and mortality rates.

PH is a complication of various hematologic diseases including myeloproliferative neoplasms (MPNs) which are included in group 5 ph.

Myeloproliferative neoplasms (MPNs) are a group of diseases characterized by uncontrolled proliferation of at least one myeloid series due to an abnormal hematopoietic cell clone. There are different types of MPNs including polycythemia vera (PV), essential thrombocythemia (ET), chronic myeloid leukemia (CML), and primary myelofibrosis (PMF).

PH is defined as an elevation in the mean pulmonary artery pressure (mPAP) that is greater than or equal to 25 mmHg, which was measured at rest via right heart catheterization (RHC).

Systolic pulmonary artery pressure (sPAP) can be accurately estimated using Doppler transthoracic echocardiography (TTE), recent advances in noninvasive imaging led Doppler TTE to become the most widespread and well-recognized technique for non-invasive sPAP evaluation and the screening modality of choice for evaluating PH.

Active monitoring of PH in patients with MPN may be warranted. Identification of risk factors predicting PH in MPN patients promises early detection and possibly improved PH management and therapy.

Eligibility Criteria:
Inclusion Criteria:

1. Adult patients (≥18 years)
2. patients diagnosed with MPNs. including polycythemia vera (PV), essential thrombocythemia (ET), chronic myeloid leukemia (CML), and primary myelofibrosis (PMF)

Exclusion Criteria:

1. patients less than 18 years old.
2. patients with cardiac diseases involving the left side of the heart or congenital heart diseases.
3. patients with chronic lung disease and primary pulmonary hypertension.
4. patients with chronic kidney disease.
5. patients with inherited and acquired chronic hemolytic anemia.
6. patients with connective tissue diseases.
7. patients with with past or current pulmonary embolism.
Online Intervention for Cancer Patients

This study will focus on supporting cancer patients who often experience emotional challenges like anxiety and depression. It will test a two-week online program called Acceptance and Commitment Therapy (ACT), designed to help people manage difficult emotions and focus on what matters most in their lives.

The program will include short, easy-to-follow sessions covering helpful strategies like accepting distress and staying present in the moment. Participants will be randomly assigned to either join the ACT program or wait for the program while continuing their usual care. The study aims to determine whether the ACT program can reduce psychological distress, anxiety, and depression in cancer patients. The study will use a mixed-methods approach, combining both quantitative data (such as changes in distress, anxiety, and depression) and qualitative insights from participant interviews. This will help us gain a deeper understanding of how the ACT program may support the psychological distress of cancer patients.


Eligibility Criteria:
Inclusion Criteria:

* age 18 and above;
* diagnosed cancer with a clear disease course
* fluent in Chinese with the ability to read and understand questionnaires independently;
* ability to operate a smartphone independently;
* not participating in or intervening in other clinical studies.

Exclusion Criteria:

* younger than 18 years of age
* unable to use a smartphone
* have significant cognitive impairment or a serious systemic disease or psychiatric disorder
* concurrently participating in other clinical studies or undergoing other psychotherapy
Efficacy of SUN N4057 in Subjects With Acute Ischemic Stroke and Measurable Penumbra on Magnetic Resonance Imaging (MRI)

This research study is designed to evaluate the safety, tolerability, and efficacy of SUN N4057 (piclozotan) in subjects with acute ischemic stroke within 9 hours of the onset of symptoms.

The primary objective of the study is to determine the efficacy of a 72 hour infusion of SUN N4057 (piclozotan) in subjects with clinical findings of an acute ischemic stroke and a magnetic resonance imaging (MRI) demonstrating a measurable penumbra (perfusion-weighted imaging \[PWI\] minus diffusion-weighted imaging \[DWI\] volume). Efficacy will be determined by comparing the proportion of subjects with no growth in stroke lesion volume as assessed by DWI at Screening to stroke lesion volume assessed by FLAIR (fluid-attenuated inversion recovery) on Day 28 in the piclozotan group versus the placebo group.

Eligibility Criteria:
Inclusion Criteria:

General inclusion criteria:

* Males or females \>= 18 and \<= 85 years of age at randomization. Female subjects must be either:

  * Surgically sterile;
  * Postmenopausal for at least 1 year; or
  * Non-pregnant, confirmed by a serum pregnancy test, and using a method of birth control that is acceptable to the investigator.
* Neurological examination demonstrating localizing cortical signs
* Receipt of study drug less than 6 hours (50% of subjects) or between 6 and 9 hours, inclusive, (50% of subjects) after the onset of symptoms (for un-witnessed stroke, last time seen in normal state or at bedtime for un-witnessed stroke during sleep)
* Signed informed consent from subject or legally acceptable representative
* NIHSS score of 6 - 22, inclusive, or at least 2 on the aphasia item of the NIHSS with a location of MRI findings consistent with aphasia

MRI-determined inclusion criteria:

* Acute ischemic stroke with substantial cortical involvement in the middle cerebral artery (MCA) distribution, as verified by the Screening DWI abnormality and/or Screening PWI abnormality. (Note: white matter involvement, in addition to cortex, is not an exclusion.)

Exclusion Criteria:

General exclusion criteria:

* Two or more of the following:

  * Reduced level of consciousness (score \>= 2 on NIHSS Q1a)
  * Forced eye deviation or total gaze paresis (score of 2 on NIHSS Q2)
  * Dense hemiplegia (no movement) of upper and lower extremities (score of 4 on NIHSS Q5 regarding motor arm and a score of 4 on NIHSS Q6 regarding motor leg)
* Pre-stroke modified Rankin score \>= 2 at Screening
* Rapid neurological improvement from Screening up to the start of drug infusion
* Persistent systolic blood pressure (SBP) \> 220 mmHg and/or diastolic blood pressure (DBP) \> 120 mmHg (confirmed by at least three readings taken at least 3 minutes apart) prior to randomization. If subsequent readings are consistently below these levels, either spontaneously or following mild antihypertensive therapy, subject may be enrolled.

MRI-determined exclusion criteria:

* Intracranial hemorrhage as verified by Screening MRI. (Note: intracranial hemorrhage on pre-screen computerized tomography \[CT\] scan also excludes subject.)
iDAP Injection in the Treatment of Parkinson's Disease

The goal of this clinical trial is to evaluate the safety, tolerability and preliminary efficacy that iDAP has on Parkinson's disease (PD) patients.

Parkinson's disease (PD) is a common neurodegenerative disease in the middle-aged and elderly. It is the "third killer" of the middle-aged and elderly after tumors and cardiovascular and cerebrovascular diseases. Its main clinical manifestations are resting tremor, reduced voluntary movement, muscle rigidity, postural reflex impairment, and autonomic dysfunction, which seriously affect patients' work ability and quality of life. It is estimated that nearly 100,000 people in China become new Parkinson's patients every year. Experts from the World Health Organization predict that the number of Parkinson's patients in China will reach 5 million in 2030, which will be more than half of the world's total. As the disease progresses, the symptoms of Parkinson's patients will become increasingly severe. The high prevalence and high disability rate of Parkinson's disease bring heavy burdens to individuals, families, and society.

Eligibility Criteria:
Inclusion Criteria:

* Ages between 45 and 75 years;
* Diagnosed to be Parkinson's disease patients according to MDS Parkinson's disease diagnostic criteria;
* Disease history 4-20 years;
* Hoehn and Yahr Stage 2-4;
* Stable dose of dopamine for more than 3 months;
* Improvement of MDS-UPDRS part III;

Exclusion Criteria:

* Patients who have previously undergone brain surgery;
* Past use of stem cell therapy or participation in stem cell clinical research;
* Cognitive impairment;
* History of mental disorders;
* Patients with other serious systemic diseases;
* Past or current metastatic malignant tumors.
Diagnostic Accuracy of Handheld vs Traditional Ultrasound

Patients receiving a point-of-care ultrasound will be randomized into a portable, handheld device or a traditional cart-based ultrasound machine to compare diagnostic capability.

Patients who require a point-of-care ultrasound examination of their kidneys, gallbladder, heart, lung, or aorta will be enrolled. Once enrolled, the patient will be randomized to receive the point-of-care ultrasound using a portable, handheld ultrasound or a traditional cart based model. The ultrasound examinations will be performed by emergency medicine post-graduate year 1-3 residents or an ultrasound fellow and reviewed by the supervising emergency medicine attending physicians credentialed in performing and interpreting point-of-care ultrasound.

Based on the clinical presentation, the provider will perform one of the following ultrasounds: cardiac to assess ejection fraction ( \<50%, 30-50%, \<30%), lung to assess for presence or absence of B-lines, gallbladder to assess for the presence or absence of gallstones, renal to assess for the presence or absence of hydronephrosis, or aorta to assess for the presence or absence of an aneurysm. The diagnostic accuracy of the portable, handheld and the cart-based model will be assessed using the following as the diagnostic standard: cardiology-interpreted echocardiogram, radiology-interpreted ultrasound or computed tomography, or quality review of the point-of-care ultrasound by 3 ultrasound fellowship trained physicians.

Eligibility Criteria:
Inclusion Criteria:

1. English and Spanish-speaking patients, who require a gallbladder, cardiac, renal, aorta, or lung ultrasound based on the discretion of the treating physician.

Exclusion Criteria:

1. All other non-English and non-Spanish speaking patients
2. Vulnerable groups
3. Patients unable to consent
Trial of Endobronchial Ultrasound Guided Fine Needle Aspiration Techniques

Endobronchial ultrasound-guided transbronchial fine needle aspiration (EBUS-TBNA) techniques have not been well studied. The investigators will conduct a randomized study comparing the diagnostic yield and specimen quality of EBUS-FNA performed with and without suction applied.

Consecutive patients with suspected malignant peribronchial masses or lymph nodes undergoing endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) will be enrolled. All participants will have 4 needle aspirations of each targeted peribronchial lesion. Two needle aspirations will be performed while applying suction and 2 needle aspirations will be performed without applying suction in random order. The investigators will compare the diagnostic yield and the quality of the specimens obtained using the two techniques.

Eligibility Criteria:
Inclusion Criteria:

* Adult undergoing EBUS at AUBMC for suspected malignancy

Exclusion Criteria:

* Coagulopathy
* The lesion cannot be sampled because of intervening tumor or blood vessels.
A Pilot Observational Study to Assess the Ability of Continuous 'Home' EEG to Accurately Diagnose Narcolepsy and Demonstrate Response to Treatment

The goal of this pilot observational study is to assess the ability of continuous 'home' EEG to accurately diagnose Narcolepsy in children and young people with hypersomnia. The main question\[s\]it aims to answer are:

* can ambulatory home monitoring using a Dreem headband with a 'life as usual' unrestricted protocol allow accurate diagnosis of Narcolepsy, compared to gold standard in-patient PSG and MSLT
* which EEG derived sleep parameters and study duration yield most diagnostic accuracy

Participants undergoing investigation for hypersomnia will additionally be asked to wear a Dream Headband at night for weeknights, then continuously for 48 hours over the weekend. The data from the headband will then be analysed to see if it can predict the results of the polysomnography and MSLT that form routine clinical care.


Eligibility Criteria:
Inclusion Criteria:

* Participants already under investigation within GSTT children and adult sleep service for hypersomnolence
* Age 12 to 25 years of age at recruitment
* Participants able to understand patient information (information including DH instructions written only in English for this initial observational study) and who can provide written informed consent or assent.

Exclusion Criteria:

* Any physician diagnosed sleep disorder (e.g. sleep apnea)
* Any physician diagnosed medical or psychiatric disorder that could explain their excessive daytime sleepiness
* Regular use of either prescribed or recreational medication that affects sleep
* Participation in another concurrent research study
Evaluation of EarlySense Home Care Tele-monitoring Device -For Early Detection of Deterioration For Cardiac Patients at Home

The aim of this study is to evaluate the relevance of the information as provided by the EarlySense Home care Tele-monitoring system can provide relevant flagging information for clinicians to identify the patients at higher risk to proactively assess patients' condition

Study objectives include:

1. Assess if and to what extent the flags provided by EarlySense Home care tele-monitoring provides relevant clinical information that can help case managers / nurses of home care agency to detect patients who need further assessment and perhaps early intervention to minimize hospitalization (re-admission to hospital).
2. Use data to further optimize a decision algorithm utilizing changes in physiological data over time (i.e., hours to days) which may identify patients at higher risk for poor outcomes (flagging algorithm).
3. Assess the acceptability of the EarlySense Home care device by clinicians
4. Assess the acceptability of the EarlySense Home care device by patients at home and their families, in their own home as determined by a provided questioner

Eligibility Criteria:
Inclusion Criteria:

* Age 21 and up
* Any patient hosted in Shelev with geographically resident over 50 km from Sheba Medical Center/ Shelev
* Patients agrees to sign the consent form and comply with study protocol.

Exclusion Criteria:

* Patients do not agree to sign the consent form
* Planned readmission within 30 days of discharge from hospital
* Going home to hospice care.
* Patients with cognitive constraints or disabilities
16 Week Efficacy and 2 Year Long Term Safety and Efficacy of Secukinumab in Patients With Active Ankylosing Spondylitis

This study will assess the efficacy and safety of secukinumab in patients with active ankylosing spondylitis who are intolerant to or have had an inadequate response to NSAIDs, DMARDs and / or TNFα inhibitor therapy.


Eligibility Criteria:
Inclusion criteria:

* Male or non-pregnant, non-lactating female patients at least 18 years of age
* Diagnosis of moderate to severe AS with prior documented radiologic evidence (X-ray) fulfilling the Modified New York criteria for AS (1984)
* Patients should have been on NSAIDs with an inadequate response
* Patients who are regularly taking NSAIDs as part of their AS therapy are required to be on a stable dose
* Patients who have been on an anti-TNFα agent (not more than one) must have experienced an inadequate response

Exclusion criteria:

* Chest X-ray with evidence of ongoing infectious or malignant process
* Patients with total ankylosis of the spine
* Patients previously treated with any biological immunomodulating agents except for those targeting TNFα
* Previous treatment with any cell-depleting therapies
* Other protocol-defined inclusion/exclusion criteria may apply
In Vivo Versus Augmented Reality Exposure for Small Animal Phobia

The aim of this study is to explore the differential efficacy of in vivo exposure versus augmented reality exposure in the treatment of specific phobia (small animals).

The hypothesis is: There will not be significant statistical differences in the efficacy of in vivo exposure therapy versus augmented reality exposure in the treatment of specific phobia (small animals).

Among anxiety disorders, specific phobias are highly prevalent (around 7.2% and 11.3% in the general population). Cockroach or spider phobia is a type of specific phobia, animal type. The gold standard for the treatment of specific phobia (included small animal phobia) is in vivo exposure. Most phobia sufferers (60-80%) never seek treatment. Besides, not all patients benefit from in vivo exposure, given that an important amount of them do not accept the intervention or drop out (around 25%) when they are informed about the intervention procedure.

Information and Communication Technologies (ICT) like Virtual Reality (VR) and Augmented Reality (AR) are pioneer applications that can improve treatment adherence and acceptance. There exist some studies offering preliminary evidence of the efficacy of AR for the treatment of small animal phobia. However, there are not any controlled study exploring the differential efficacy of ICT-based exposure interventions versus in vivo exposure. In the present study the differential efficacy of AR exposure versus in vivo exposure for the treatment of small animal phobia is explored with a between subject randomized controlled trial. A pre-treatment assessment will be conducted in order to establish the diagnosis and evaluate the main outcome measures. All participants will receive an intensive exposure session following Öst guidelines, (in vivo exposure in one experimental condition and AR exposure in the other experimental condition). After the treatment a post-treatment assessment will be carried out as well as follow-up assessments at 3- and 12-month after treatment completion.

Eligibility Criteria:
Inclusion Criteria:

* Be between 18-65 years of age.
* To meet current DSM-IV-TR criteria for specific phobia (animal type)
* Have as the major presenting complaint anxiety in, and avoidance of, a large range of situations involving spiders or cockroaches.
* A minimum of 1 year duration of the phobia.
* To have scores over 4 in phobic avoidance (on a scale of 0 to 8).
* Express a willingness to participate in the study.

Exclusion Criteria:

* To be able to put a hand inside the container with a spider or cockroach during the behavioral test.
* Have other psychiatric problem in immediate need of treatment.
* Have psychotic or organic symptoms.
* Have heart or lung disease.
* Current alcohol or drug dependence or medication.
The Efficacy of Neoadjuvant Atezolizumab Treatment in Patients With Advanced Urothelial Bladder Cancer

Recently, promising evidences that blocking PD-1 and PD-L1 is an efficacious way to treat advanced stage bladder cancer patients. Atezolimumab is the first PD-L1 inhibitor approved by US FDA for advanced UBC in June 2014. These novel agents will become the standard therapy for unhopeful UBC patients who fail to respond to cisplatin-based chemotherapy and finally, the first-line treatment would be changed from cisplatin-based chemotherapy to immune check point inhibitors for advanced UBC, particularly neoadjuvant setting.

Additionally, along with enormous analysis of genomic landscape of bladder cancer, a consensus was reached regarding the existence of a group of Basal-Squamous-like tumors - designated BASQ - characterized the high expression of KRT5/6 and KRT14 and low/undetectable expression of FOXA1 and GATA3. This novel molecular classification can improve the identification of optimal patient population for different treatment modalities. Specifically, luminal type and basal type may have different treatment response and prognosis after initial definitive treatment, such as neoadjuvant treatments.

However, there is no evidence for this topic, particularly the clinical efficacy of neoadjuvant PD-L1 inhibitors according to the BASQ classification in patients with advanced urothelial bladder cancer.


Eligibility Criteria:
Inclusion Criteria:

* ≥18 years of age
* Histologically confirmed muscle-invasive urothelial carcinoma
* Patients undergoing radical cystectomy
* Advanced status requiring neoadjuvant systemic therapy
* ECOG performance status score of 0 or 1
* Adequate organ and hematologic functions
* Available IHC data for the BASQ classification

Exclusion Criteria:

* Non-urothelial carcinoma histology
* Active autoimmune disease or inflammatory bowel disease
* Prior severe or persistent immune-related adverse events
* Previous exposure to anti-PD-1 or anti-PD-L1 therapy
* Requirement for 10 mg/d of prednisone or equivalent
* Inadequate liver, kidney function and hematologic dysfunction
* Inoperable case, such as untreated CNS metastases
* No available archival tumor tissue for evaluating the BASQ classification
Cocaine in Parotid Saliva, Blood and Urine - 4

The purpose of this study is to establish the use of parotid saliva as a means of detecting and quantifying cocaine and its metabolites.


Eligibility Criteria:
Please contact site for information.
Greatest International Antiinfective Trial With Avelox

The observation period for each patient covered an initial treatment period with Avelox® plus optional 2 long-term follow-up periods (6 and 12 months).For each patient, the physician documented data at any initial visit (baseline) and at least one short-term follow-up visit (=initial treatment period).Optionally, long-term follow-ups (6 and 12 months) were documented, and a patient questionnaire was filled in.


Eligibility Criteria:
Inclusion Criteria:

* Outpatients with diagnosis of AECB and decision taken by the investigator to prescribe moxifloxacin

Exclusion Criteria:

* Exclusion criteria must be read in conjunction with the local product information