cyrilzakka/clinical-trials huggingface dataset:
Observational Registry to Evaluate Real World Usage of PiCSO Impulse System in STEMI Patients as Part of Post-marketing Surveillance

A prospective, multicenter, single-arm, open label registry of commercially treated patients with PiCSO Impulse System.

This is a observational registry study. Patients with an ST-segment elevated anterior infarct eligible for PCI and commercial PiCSO treatment will be invited to participate in the PiCSO-AMI-IV study. After having given consent as per approved ethics committee requirements, the PCI of the culprit vessel should be performed per standard practices. After blood flow restoration, the coronary sinus (CS) will be cannulated through the femoral vein and the PiCSO Impulse Catheter will be placed in the CS to start the PiCSO therapy. After the procedure the patient will be followed for safety assessments at 30 days, 6 months, 1 year, 2 year and 3 years post index procedure.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years old
2. Culprit lesion in proximal or mid LAD
3. ST-segment elevation
4. Pre-PCI TIMI flow 0 or 1.
5. Symptoms onset time consistent with myocardial ischemia (e.g. persistent chest pain, shortness of breath, nausea/vomiting, fatigue, palpitations or syncope) ≤ 12 h.
6. Patient is deemed eligible for PCI
7. Consent as per approved national ethical committee specific requirements prior to the procedure.

Exclusion Criteria:

1. Patients with contraindications to percutaneous insertion or angiography
2. Patients with implants or foreign bodies in the coronary sinus
3. Known allergy to polyurethanes, PET or stainless steel
4. Known pregnancy or breast feeding
5. Known pericardial effusion or cardiac tamponade
6. Known central hemodynamically relevant left/right shunt
7. Patients with symptom onset \> 12 hours
8. Patients with previous CABG
9. Patients with a history of stroke, TIA or reversible ischemic neurological deficit within last 6 month.
10. Patients with coagulopathy
11. Patients under judicial protection, legal guardianship or curatorship.
Ultrasound Evaluation of Crohn's Disease

The purpose of this study is to assess the effectiveness of a new ultrasound technology for evaluating Crohn's disease.

The investigators will study the efficacy of ultrasound shear wave elastography and vascularity imaging for Crohn's Disease (CD) evaluation. Literature evidences demonstrate that bowel stiffness is correlated with fibrosis, while bowel vascularity and perfusion is correlated with inflammation. Therefore, the investigators expect the combination of shear wave elastography and vascularity imaging can increase the sensitivity and specificity of CD evaluation.

Ultrasound is safe, cost-effective, and widely accessible, thus provides an attractive alternative to the clinical standard Computed Tomography (CT), risks of radiation)) and Magnetic Resonance Imaging (MRI), more expensive and limited accessibility)).

Because ultrasound may not be able to image bowel loops deep in the body, its main role is for follow-up after initial screening by CT or MRI, especially for terminal ileum, which is easily accessible by ultrasound and the most frequently affected bowel segment for CD.

Eligibility Criteria:
Inclusion Criteria:

- Crohn's disease patients with involvement of terminal ileum (thickness \> 3mm).

Exclusion Criteria:

* Patients with change of medicine or going to surgery over the 6-months follow-up period.
* Patients with unreliable ultrasound images due to conditions such as large body habitus or poor ultrasound imaging window.
* Adults lacking capacity to consent.
* Vulnerable subjects such as prisoners.
* Pregnant women and nursing mothers.
* Patients with known or suspected right-to-left, bi-directional, or transient right-to-left cardiac shunts.
* Patients with history of hypersensitivity allergic reactions to ultrasound contrast agents.
Azacitidine Combined With Chidamide in the Treatment of Newly Diagnosed PTCL Unfit for Conventional Chemotherapy

This prospective, open-label, single-arm study will evaluate the efficacy and safety of azacitidine in combination with chidamide in treatment of newly diagnosed peripheral T-cell lymphoma unfit for conventional chemotherapy.

Peripheral T-cell lymphoma (PTCL is a distinct and heterogeneous histopathologic subtype of non-Hodgkin lymphoma (NHL), accounting for \~10%. CHOP regimen has been widely used in PTCL patients even with unfavourable prognosis, with 5-year overall survival rate of 38.5%. Elderly patients seldom benefit from conventional CHOP regimen. A study showed that CR rate was only 18.1% in elderly patients (median age of 80 years old, ranging from 56 to 93 years old).

Azacitidine combined with romidepsin has been proved efficient in relasped or refractory PTCL, with CR rate of 55%. This prospective, open-label, single-arm study will evaluate the efficacy and safety of azacitidine in combination with Chidamide in treatment of newly diagnosed peripheral T-cell lymphoma unfit for conventional chemotherapy.

Eligibility Criteria:
Inclusion Criteria:

* Pathologically confirmed peripheral T-cell lymphoma based on 2016 WHO classification
* Treatment naive
* Age ≥ 18 years
* Unfit for converntional chemotherapy meeting criteria as following but not limited to: age ≥75, ECOG \>2，ADL\<100 or CCI\>1.
* Must has measurable lesion in CT or PET-CT prior to treatment
* Expected lifetime ≥ 3 months
* Informed consented

Exclusion Criteria:

* Has accepted localized or systemic anti-lymphoma treatment
* Has accepted autologous Stem cell transplantation before
* History of malignancy except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix prior to study treatment
* Uncontrollable cardio-cerebral vascular, coagulative, autoimmune, serious infectious disease
* Primary CNS lymphoma
* Left EF≤ 50%
* Lab at enrollment (Unless caused by lymphoma): Neutrophile\<1.5\*10\^9/ L ;Platelet\<75\*10\^9/L; ALT or AST \>2\*ULN; Creatinine\>1.5\*ULN
* Other uncontrollable medical condition that may that may interfere the participation of the study
* Not able to comply to the protocol for mental or other unknown reasons
* Patients with mentally disorders or other reasons unable to fully comply with the study protocol
* Pregnant or lactation
* HIV infection
* HBV-DNA and HCV-RNA undectable.
Smoking Cessation in Alcoholics

Most alcohol-dependent individuals are heavy smokers. The aim of this study is to evaluate whether a specific smoking cessation program (based on cognitive-behavioral therapy) for inpatient alcohol-dependent smokers is more effective than a control condition (treatment as usual).

The study is designed as a randomised, controlled trial conducted in an inpatient alcohol treatment institution. Shortly after alcohol detoxification, smokers are offered to voluntarily participate in a smoking cessation program. Participation is possible if patients either want to stop smoking or to reduce their consumption for at least 50%. Patients are asked about their smoking behaviour at the following time points: at admission (T0), after finishing the smoking cessation program or the control condition (T1), one month later by phone (T2) and six months later in a closing meeting (T3). Urine samples and CO-breath controls are taken to check both nicotine and alcohol abstinence.

Eligibility Criteria:
Inclusion Criteria:

* alcohol-dependent
* smoker
* intend to stop or reduce smoking for at least 50%

Exclusion Criteria:

* taking part in another smoking cessation program
* being pregnant
* not able to understand instruction due to cognitive impairment
A Comparison of Multidetector CT and TE in the Diagnosis of Congenital Cyanotic Heart Diseases

Multi-detector computed tomography angiography (MDCTA) provides high-resolution images of the heart and its vasculature, allowing for accurate anatomical assessment, detection of complex cardiac morphology,

evaluation of coronary artery anatomy, and identification of extracardiac anomalies including the coronaries, pulmonary arteries, aorta, and pulmonary or systemic veins, and it delineates vessel walls and also displays the airway, mediastinal abnormalities, and pulmonary parenchyma by using contrast media. This modality is particularly useful for evaluating complex cardiac anatomy and identifying potential surgical or interventional targets.

Eligibility Criteria:
Inclusion Criteria:

* age above 18 and less than 65.
* having Congenital Cyanotic Heart Diseases

Exclusion Criteria:

* heart surgery
* other heart issues
* not consented
Evaluation of Ocular Surface Tumors Using Anterior Segment Optical Coherence Tomography (OCT)

optical coherence tomography (OCT) can scan a range of ocular tissues and take high-resolution image sections during ophthalmic examination..

and recommended as a rapid, informative and quite reliable method of examination to differentiate benign from malignant ocular surface tumors.

The conjunctiva is an anatomical site with a prominent risk of squamous cell carcinoma development, which is a unique biological behavior. The superficial lesion with significant epithelial cell growth usually displays unique data, contributing to unusual ocular tumors.

Anterior segment optical coherence tomography (AS-OCT), as a noninvasive, high-resolution imaging technique, provides crucial morphological and anatomical information in ocular surface tumors via visualizing the layer structure of the cornea and anterior segment, qualifying tumor morphology, and quantifying thickness and extension. AS-OCT can provide valuable information for helping in clinical diagnoses, differential diagnoses, prognoses, and evaluating responses to treatments as a significant imaging tool in ocular surface tumors.

The correct diagnosis and classification of ocular surface tumors are crucial aspects of their proper management.

the aim of the study • To evaluate the imaging characteristics of ocular surface tumors on high-resolution anterior segment optical coherence tomography (ASOCT).

optical coherence tomography (OCT) can scan a range of ocular tissues and take high-resolution image sections during ophthalmic examination..

and recommended as a rapid, informative and quite reliable method of examination to differentiate benign from malignant ocular surface tumors.

The conjunctiva is an anatomical site with a prominent risk of squamous cell carcinoma development, which is a unique biological behavior. The superficial lesion with significant epithelial cell growth usually displays unique data, contributing to unusual ocular tumors.

Anterior segment optical coherence tomography (AS-OCT), as a noninvasive, high-resolution imaging technique, provides crucial morphological and anatomical information in ocular surface tumors via visualizing the layer structure of the cornea and anterior segment, qualifying tumor morphology, and quantifying thickness and extension. AS-OCT can provide valuable information for helping in clinical diagnoses, differential diagnoses, prognoses, and evaluating responses to treatments as a significant imaging tool in ocular surface tumors.

The correct diagnosis and classification of ocular surface tumors are crucial aspects of their proper management.

the aim of the study • To evaluate the imaging characteristics of ocular surface tumors on high-resolution anterior segment optical coherence tomography (ASOCT).

Eligibility Criteria:
Inclusion Criteria:

* all patients presented with ocular surface lesion suspected to be neoplastic

Exclusion Criteria:

* all patients presented with ocular surface lesion proved by pathology not to be neoplastic
Connect Lung Outcomes With Bronchodilator Use

To determine the accuracy of the Respimetrix flow-volume monitoring device in measuring the patient's inspiratory capacity as compared to gold-standard measurements of inspiratory capacity on pulmonary function testing. Accuracy will be assessed before and after (A) pulmonary function testing and before and after (B) the administration of an inhaled bronchodilator medication.

1. Specific Aim #1: Compare the performance of the flow-volume test device to standard pulmonary function measurements.

   The investigators hypothesize that measurements of inspiratory capacity with the Respimetrix test device will:

   A. Accurately measure the inspiratory capacity as assessed on standard pulmonary function tests, and will B. Correlate with other measures of pulmonary function including spirometry (vital capacity, forced expiratory volume in 1 second) and lung volumes (total lung capacity, functional residual capacity and residual volume).
2. Specific Aim #2: Examine the ability of the flow-volume test device to track changes in standard pulmonary function measurements after the administration of an inhaled bronchodilator.

The investigators hypothesize that the Respimetrix test device will:

A. Accurately measure changes in inspiratory capacity in response to a standard dose of a short acting inhaled beta-agonist (4 puffs albuterol), B. Correlate with immediate changes in pulmonary function parameters including spirometry (vital capacity, forced expiratory volume in 1 second) and lung volumes (total lung capacity, functional residual capacity and residual volume).

Eligibility Criteria:
Inclusion Criteria:

* Patients 18 years of age or older who are being seen in the pulmonary clinic including Asthma and Chronic Obstructive Pulmonary Disease (COPD) patients.
* Patients must be willing and able to provide informed consent to participate in the study.
* Patients must be able to use a metered dose inhaler.

Exclusion Criteria:

* Contraindication to inhaler use
* Tracheostomy
* Incapacitating disability that interferes with the use of the inhaler or execution of the protocol
* Unable to understand informed consent (e.g., non-English speakers)
Interactive Spaced Education to Optimize Diabetes Care

Investigators are conducting a randomized controlled trial to determine whether an online team-based spaced education (SE) game can improve HbA1c levels among these patients with diabetes (primary aim). Secondary aims include determining the impact of the game on patients' pill possession ratio (PPR) of oral DM meds and their microalbumin/creatinine (M/C) ratio, ACE PPR, and ARB PPR.

Participants will be randomized to one of two cohorts: (1) the intervention cohort will participate in an online team-based game on diabetes self-management education (DSME) and will receive a paper documents on American history, and (2) the 'attention control' cohort will participate in an online team-based game on American history and will receive a paper documents on DSME. Each game would consist of 2 questions per week x 25 weeks = 50 questions total per arm. The questions are delivered via email by the Qstream platform to the participants. Upon clicking on a hyperlink in the email, participants select an answer that is downloaded to a server. They are then provided with the answer to and explanation of the question, along with additional educational materials. Using an adaptive methodology, the spacing and content of the game material will be individualized for each clinician based on their performance. Home-based testing of HbA1c and M/C ratio will be conducted by patients at enrollment, 6 months and 12 months. If successful, this SE game will improve diabetes management among VA patients and improve patient outcomes. Given the growing use of email and the Internet by patients, SE games could be easily expanded to a broad audience of VA patients with varying health problems across the country. With content tailored to meet specific needs, SE games can be utilized as tools to improve patients' clinical outcomes by bolstering their health management behaviors.

Eligibility Criteria:
Inclusion Criteria:

* Patients in the northeastern Veterans Affairs hospital system who are taking oral diabetes medications, have a PPR\<80%, and have a HbA1c \>7.5.

Exclusion Criteria:

-
Hemodynamic Changes of Upper and Lower Extremities After Spinal Anesthesia

The aim of this study is to evaluate the changes of venous flow, volume, and resistance in upper (basilic v.) and lower (popliteal v.) extremities of the elderly healthy patients compared with elderly hypertensive patients who undergoing spinal anesthesia for transurethral prostatectomy.


Eligibility Criteria:
Inclusion Criteria:

* \> 65yr men
* who undergoes spinal anesthesia for elective TURP
* normotensive/hypertensive

Exclusion Criteria:

* vascular disease
* contraindications for spinal anesthesia
Unveiling Patient Experiences in Testicular Cancer Clinical Trials

Clinical research participation has historically been heavily biased toward specific demographics.

Several people will be invited to enroll in this study so that it may collect a variety of data about testicular cancer clinical study experiences and identify barriers to participation as well as the causes of participants' failure or withdrawal.

People with testicular cancer who are invited to take part in medical research will benefit from the analysis of the data.


Eligibility Criteria:
Inclusion Criteria:

* Aged ≥ 18 years old and ability to provide written informed consent obtained prior to participation in the study and any related procedures being performed
* Diagnosis of testicular cancer
* No prior treatment for testicular cancer

Exclusion Criteria:

* Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
* Enrolled in another research study
* Inability to provide written informed consent
Tear Analysis in the Diagnosis of Multiple Sclerosis

In the primary progressive multiple sclerosis, the detection of oligoclonal bands in cerebrospinal fluid is critical for the diagnosis. However, lumbar puncture for cerebrospinal fluid collection is considered relatively invasive. Our hypothesis is that oligoclonal bands detection in tears is possible and useful for the diagnosis of multiple sclerosis.

The objective of the present study is to assess concordance between oligoclonal bands detection in tears and in cerebrospinal fluid. We will include patients with primary progressive multiple sclerosis and we will compare results of oligoclonal bands detection by isoelectric focusing in cerebrospinal fluid and tears. Tears will be collected using a Schirmer strip. This would circumvent the practice of invasive lumbar punctures currently used in multiple sclerosis diagnosis.

Eligibility Criteria:
Inclusion Criteria:

* 18 years old or more
* Progressive neurological deficit after 12 months
* At least 9 T2 brain lesions of minimum 3 mm evidenced by MRI and/or four or more T2 lesions of minimum 3 mm with positive Visual Evoked Potential and/or positive spinal cord MRI (at least two focal T2 lesions)

Exclusion Criteria:

* Asiatic persons
* recurrent forms of the disease
* Persons wearing contact lenses
* Ocular Infection
* Corticoid treatment at least 30 days before sampling
* immunosuppressive or immunomodulatory treatment 3 months before sampling
Effectiveness of Additional Acupuncture Therapy for Lung Cancer Patients

This study aims for evaluating the effectiveness, safety and feasibility of additional acupuncture therapy for lung cancer patients who are under chemotherapy in an inpatient setting. The acupuncture therapy will be administered during a resting period between cycles of chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age
* Karnofsky Performance Status (KPS) 60% or more
* Undergoing antineoplastic chemotherapy for lung cancer
* Able to provide informed consent

Exclusion Criteria:

* Brain metastasis, stroke or major psychiatric diseases
* Active infection
* Severe heart disease
* Serious systemic diseases such as uncontrolled hypertension and diabetes mellitus
* Acupuncture therapy within the previous three months
* Communication disorder
* Unwillingness to participate in the trial
* Severe immunocompromised state (absolute neutrophils count \< 1000/cubic mm)
Mobile Health Delivered Lifestyle Intervention Program in Patients With NASH

There is a clear unmet clinical need for effective lifestyle intervention in patients with nonalcoholic steatohepatitis (NASH). Patients have self-identified multiple barriers to effective lifestyle intervention can be removed with a mobile health (mHealth) platform.

This study will be a proof of concept study to evaluate weight loss efficacy of Noom Healthy Weight (HW), a mHealth lifestyle intervention, in patients with NASH.


Eligibility Criteria:
Inclusion Criteria:

* Adults age \>18 years
* NASH defined as:
* Liver biopsy with evidence of steatohepatitis (NAS \>=4) or;
* Imaging study (e.g., ultrasound, CT, MRI) with hepatic steatosis and one of the following:
* Fibroscan kPa \>8.2 or;
* FAST \> 0.35 or;
* FIB-4 \>= 1.45 or;
* Possession of a smartphone

Exclusion Criteria:

* Active or recent (\<90 days) participation in lifestyle intervention program, including weight-loss program
* Active weight-loss supplement use
* Cirrhosis
* Inability to provide informed consent
* Institutionalized/prisoner
* Other chronic liver disease (e.g., viral hepatitis)
* Recent Noom use (\<180 days)
* Secondary cause of hepatic steatosis, including significant alcohol consumption (men \>30g/d, women \>20g/d)
* Severe medical comorbidities/psychiatric illness at the discretion of the study PI
A Phase 2 Study of Berberine Ursodeoxycholate (HTD1801) in Patients With Type 2 Diabetes Inadequately Controlled With Diet and Exercise

The goal of this clinical trial is to evaluate the efficacy and safety of berberine ursodeoxycholate (HTD1801) compared to placebo in patients with type 2 diabetes inadequately controlled with diet and exercise alone.

This Phase 2 randomized, double-blind, placebo-controlled trial will evaluate the efficacy and safety of HTD1801 compared to placebo after 12-weeks of treatment.

To ensure stabilization of glycemic control, eligible patients will first participate in a 4-week single-blind run-in period where investigators will provide guidance on lifestyle modification, concomitant medications, and procedures for self-monitoring of blood glucose. Following this period, patient eligibility will be reassessed. Eligible patients will be randomized 1:1:1 to receive HTD1801 500 mg twice daily (BID), HTD1801 1000 mg BID, or placebo BID.

Eligibility Criteria:
Key Inclusion Criteria:

* Have been diagnosed with type 2 diabetes mellitus according to the 1999 World Health Organization (WHO) criteria
* Have followed dietary and exercise interventions for at least 8 weeks prior to screening
* Have HbA1c ≥7.5% to ≤11.0% (screening) and ≥7.0% to ≤10.5% (pre-randomization)
* Have fasting plasma glucose \<13.9 mmol/L (screening and pre-randomization)
* Have a body mass index ≥18 kg/m\^2 to ≤40 kg/m\^2

Key Exclusion Criteria:

* Have type 1 diabetes mellitus or specific type of diabetes mellitus (pancreatic injury-induced diabetes mellitus, diabetes mellitus caused by Cushing's syndrome or acromegaly, etc.)
* Have had diabetic ketoacidosis or hyperglycemic hyperosmolar state within 6 months prior to screening
* Have had 2 or more Grade 3 hypoglycemic events within 12 months prior to screening
* Have unstable or treatment-requiring proliferative retinopathy or macular degeneration, severe diabetic neuropathy, diabetic foot, or intermittent claudication within 6 months prior to screening
* Have been taking any weight loss medication or dietary supplement, have participated in a weight loss program, or have adhered to a special diet within 4 weeks prior to screening
* Have continuously used insulin or an insulin analogue for more than 14 days within 12 months prior to screening
* Have used 2 or more classes of hypoglycemic medications for more than 8 weeks within 12 months prior to screening
* Have used any glucose-modifying medications within 8 weeks prior to screening
* Have had weight gain or loss ≥5% from screening to randomization