cyrilzakka/clinical-trials huggingface dataset:
Blinded Randomized Controlled Trial of Artificial Intelligence Guided Detection of Intracardiac Thrombus

To determine whether an integrated AI decision support can save time and improve the accuracy of detection of intracardiac thrombus, the investigators are conducting a blinded, randomized controlled study of AI-guided detection of intracardiac thrombus to electrophysiologist judgment in preliminary readings of echocardiograms.


Eligibility Criteria:
Inclusion Criteria:

1. Aged 18-80 years.
2. Willing to sign informed consent.
3. Patients diagnosed with atrial fibrillation Paroxysmal AF and Persistent AF according to the latest clinical guidelines

Exclusion Criteria:

1. End-stage disease with a mean life expectancy less than 1 year
2. New York Heart Association (NYHA) class III or IV, or last known left ventricular ejection fraction less than 30%
3. Previous surgical or catheter ablation for AF
4. Bradycardia and presence of implanted ICD
5. Uncontrolled hypertension: Systolic blood pressure (SBP) \>180 mmHg or diastolic blood pressure (DBP) \> 110 mmHg
6. Patients with Cardiovascular events including acute myocardial infarction, any PCI, valvular cardiac surgical, or percutaneous procedure within the past 3 months
7. Women of childbearing potential who are, or plan to become, pregnant during the time of the study
8. Have been enrolled in an investigational study evaluating devices or drugs.
Real-Time Support for Exercise Persistence in COPD

The purpose of this exploratory study is to determine the feasibility, acceptability, and efficacy of an exercise persistence intervention for patients with chronic obstructive pulmonary disease (COPD) following pulmonary rehabilitation (PR).

Exercise, a cornerstone of PR, is effective in improving dyspnea, functioning, and health related quality of life (HRQL) in patients with COPD. However, these improvements gradually dissipate following program completion. There are currently few successful interventions that support patients' persistence with community-based exercise after PR and that have closely monitored the potentially negative impact that COPD exacerbations have on exercise behaviors. Emerging technologies such as wirelessly enabled personal digital assistants (PDA) may provide an innovative means to support exercise persistence through real-time collaborative monitoring of exercise and signs and symptoms of COPD exacerbations and reinforcement to enhance exercise self-efficacy. Patient graduates of two PR programs who have COPD (n=20) will first undergo a 2-week run-in prior to being randomized to either the MOBILE (Mobilizing Support for Long-term Exercise) intervention or attention control for 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Moderate to severe COPD (FEV1/FVC \<70% and FEV1%\<80%)
* Ability to speak, read and write English
* Age 40 or older
* Willingness to complete a 6 month program

Exclusion Criteria:

* Illnesses such as bronchiectasis, active malignancies or other end stage diseases
* Plans to continue in a maintenance program after rehabilitation.
Endoscopic Ultrasound (EUS) Guided Fine Needle Aspiration (FNA) EUS-FNA of Solid Pancreatic Mass Lesions Using a Novel Corkscrew Technique: a Pilot Study

This research is being done to investigate if a new technique to biopsy the pancreas will lead to a larger amount tissue material that can be analyzed. Investigators have called the technique the "corkscrew" technique and believe it will allow obtaining a larger biopsy sample during the endoscopic ultrasound examination. The corkscrew technique uses a clockwise rotational movement to drive the needle into the pancreatic mass (like a wine bottle opener twists and buries itself into a cork). It is believed that this will lead to a better biopsy sample than the usual way and therefore result in a higher chance of a diagnosis.


Eligibility Criteria:
Inclusion Criteria:

* In-patients and out-patients between the age of 18 and 90 years with solid pancreatic masses presenting for EUS-Fine Needle Aspiration (FNTA)

Exclusion Criteria:

* Uncorrectable coagulopathy (INR \> 1.5)
* Uncorrectable thrombocytopenia (platelet \< 50,000)
* Uncooperative patients
* Pregnant women (women of childbearing age will undergo urine pregnancy testing, which is routine for all endoscopic procedures)
* Refusal to consent form
* Prior negative FNTA
* In situ metallic biliary stents
* Predominantly cystic lesions
* Inaccessible lesions to EUS
Home Based Adaptive Arm Training for Children

Twenty pediatric patients aged 5-17 years with Acquired Brain Injuries (ABI) will be randomized to receive either a bimanual-to-unimanual device home training program (10 subjects) or a conventional non-device home training program (10 subjects) for a period of 6 weeks.

The specific aims of this proposal are to:

Aim 1: Introduce home-based targeted upper limb training in children with hemiplegia from ABI (Acquired Brain Injuries) using a bimanual-to-unimanual training approach It is hypothesized that child-friendly home-based upper limb bimanual-to-unimanual training will lead to greater compliance and improved motor outcome on the Fugl Myer Scale compared to a conventional home training program.

Aim 2: Improve the understanding of the pattern of recovery of isolated joint movements in the pediatric population with hemiplegia following ABI.

It is hypothesized that individuals receiving device-based bimanual-to-unimanual training will show improvement in active range of motion across upper limb joints compared with a conventional home training program.


Eligibility Criteria:
Inclusion Criteria:

* Acquired Brain Injury at least 3 months prior to enrollment.
* Unilateral hemiparesis
* History of compliance with home exercise programs in the past.

Exclusion Criteria:

* Any social or medical problem that precludes compliance with the protocol
* Comorbid seizure disorder or other neurological disease
* Treatment with botulinum toxin or intrathecal baclofen in the 3 months preceding enrollment
* Implanted neuromodulatory or electronic device or other complicating illness
* Lack of capacity to consent
Acupuncture for Mucositis Pain in Cancer Care

This research is being done to see if acupuncture helps relieve mucositis pain in patients with leukemia who are undergoing chemotherapy. Many patients receiving chemotherapy develop mucositis (painful sores or blisters in the mouth or throat). Mucositis is not only a frequent complication in cancer care and extremely painful, but also increases the risks of infection and malnutrition and often leads to discontinuing or delaying the chemotherapy treatments.

Acupuncture is one of the oldest, most commonly used medical procedures in the world. The practice originated in China more than 2,000 years ago, and is widely used by doctors in Korea, China, Japan, and other countries to ease pain or various symptoms. In the past two decades, acupuncture has grown in popularity in the United States, and by 2002, an estimated 8.2 million adults in the US report having used acupuncture.

The term acupuncture describes a family of procedures involving stimulation of anatomical points on the body by a variety of techniques. The acupuncture technique that has been most studied scientifically involves penetrating the skin with thin, solid, metallic needles that are manipulated by the hands or by electrical stimulation. Acupuncture needles are metallic, solid, and hair-thin. People experience acupuncture differently, but most feel no or minimal pain as the needles are inserted. Some people are energized by treatment, while others feel relaxed.

Acupuncture has been used to ease some cancer treatment-related side effects such as nausea and vomiting. In this study we will assess the potential usefulness of acupuncture to ease the pain associated with mucositis.

Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed with leukemia (such as acute myelogenous leukemia) and receiving chemotherapy for induction, consolidation or re-induction or high dose preparative regimen for bone marrow transplantation in the Johns Hopkins Oncology Inpatient Services
* Participation in standard leukemia-treatment regimens
* Expectation of survival of three weeks for completion of the study

Exclusion Criteria:

* Acupuncture treatment within the previous 6 weeks
* Unable to achieve platelet count of at least 10,000 with platelet support
* Radiation therapy within one month of enrollment
* Pregnant women
* History of substance abuse, including alcohol and IV drug users
Preoperative Prediction of Acute Kidney Injury After Cardiac Surgery

Although acute kidney injury (AKI) frequently complicates cardiac surgery, methods to determine AKI risk are lacking. Renal functional reserve (RFR), the capacity of the intact nephron mass to increase glomerular filtration rate (GFR), represents maximal filtration capacity. We hypothesized that preoperative RFR would predict postoperative AKI.

Acute kidney injury (AKI) is a frequent complication in patients undergoing cardiac surgery with an estimated prevalence of 36%. However, clinicians have limited tools to preoperatively identify patients at risk for AKI and/or progression to chronic kidney disease, particularly in patients with normal resting glomerular filtration rate (rGFR). Renal functional reserve (RFR) describes the capacity of the intact nephron mass to increase GFR from baseline in response to stimuli (e.g., protein load). We hypothesized that the presence or absence of RFR could separate patients at risk for developing AKI from patients with better-preserved renal function and a more favorable short- and long-term prognosis despite identical rGFR. The aim of this study is to examine whether preoperative assessment of RFR is able to predict risk for AKI after cardiac surgery.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects older than 18 years
2. Subjects undergoing elective cardiac surgery
3. Subjects who signed informed consent forms

Exclusion Criteria:

1. Pregnancy
2. Chronic kidney disease ≥ stage III
3. Solitary kidney
4. Diabetes mellitus type 1
5. Recent cardiac arrest
6. Liver failure or cirrhosis
7. Total parenteral nutrition
8. Hemoglobin \<11 g/dl
9. Sepsis
10. History of malabsorption, chronic inflammatory bowel disease, short bowel, or pancreatic insufficiency
11. Transplant donor or recipient
12. Active autoimmune disease with renal involvement
13. Rhabdomyolysis
14. Prostate hypertrophy with International Prostate Symptom Score ≥20
15. Neoplasm

Withdrawal criteria:

All patients included in the study were to be followed up until the scheduled end of the study. Data collection could be terminated prior to the scheduled time only under the following conditions:

* General criteria

  1. A patient or his/her legal representative may refuse further participation in the study at any time (withdrawal of consent),
  2. The investigator may withdraw a patient from the participation in the study at any time for the following reasons:

     * a severe protocol violation,
     * the development of incidents/near-incidents/other severe clinical complications related to the study protocol
* Criteria related to the study

  1. Subjects who could not stop taking angiotensin-converting enzyme inhibitors and/or angiotensin II receptor blockers a minimum of 48 hours before the protein load.
  2. Subjects who received non-steroidal anti-inflammatory drugs within the 48 hours before the protein load.
  3. Subjects who received intravenous radiocontrast agents within the 72 hours before the protein load.
Von Willebrand Disease in the Netherlands

The primary aim of this study is to prospectively investigate the current bleeding tendency of children and adults with VWD.

Von Willebrand disease (VWD) is the most common inherited bleeding disorder, and is characterized by a defective platelet adhesion and aggregation. VWD is caused by a reduced (type 1), an abnormal function (type 2) or a complete absence (type 3) of von Willebrand factor (VWF).

In recent years, large retrospective cohort studies have provided valuable insights on the clinical presentation, bleeding phenotype, quality of life, diagnostics, genetics and treatment of patients with VWD. One of these large studies is the von Willebrand in the Netherlands (WiN) study, which is a nationwide cross sectional study of moderate and severe von Willebrand disease patients, that was initiated in 2007. Over 800 VWD patients were included in the WiN study, which was about 80% of all known VWD patients in the Netherlands. Although the WiN study and large retrospective studies in other countries provided important insights in understanding VWD, some significant challenges remain and large prospective studies are lacking to provide answers.

All large retrospective cohort studies have assessed the bleeding phenotype of patients with VWD using bleeding scores or retrospective questionnaires. Bleeding scores calculate the sum of all bleeding episodes during lifetime. Therefore, they provide useful information on the bleeding tendency during lifetime. However, bleeding scores do not provide information on the change of bleeding tendency. If a patient had a period in his or her lifetime in which he or she had many bleeding episodes, then the bleeding score is high. Though, the patient could have had those bleeds 30 years ago and did not have a bleeding episode since then. Therefore, bleeding scores do not provide information on the current bleeding phenotype of VWD patients. Furthermore, previous studies provided limited information on the frequency of mild bleedings, like gum bleeding or epistaxis, that occur in daily life but do not require therapy. Nevertheless, these bleeding episodes can cause a major impairment in quality of life. This is especially important in children, because school-going children with VWD have a lower quality of life and have a different bleeding tendency, characterized by more cutaneous bleeding (81%), oropharyngeal bleeding (64%) and epistaxis (56%).

Therefore, the primary aim of this study is to prospectively investigate the current bleeding tendency of children and adults with VWD.

Eligibility Criteria:
Inclusion Criteria:

* Historically lowest VWF:Ag and/or VWF:RCo and/or VWF:CB ≤ 0.30 IU/mL and/or FVIII:C ≤ 0.40 IU/mL
* Treatment at a Hemophilia treatment center in the Netherlands
* All types of VWD
* All ages

Exclusion Criteria:

- Other known bleeding disorders present.
Linking Endotypes and Outcomes in Pediatric Acute Respiratory Distress Syndrome

The overall goal of the study is to risk stratify pediatric Acute Respiratory Distress Syndrome (ARDS) patients and to identify sub-phenotypes with shared biology in order to appropriately target therapies in future trials. This is a prospective, multicenter study of 500 intubated children with ARDS, with planned blood collection within 24 hours of ARDS onset and subsequent measurement of plasma protein biomarkers and peripheral blood gene expression.

Investigators will measure pre-determined biomarkers with known or suspected association with ARDS severity or outcome. Simultaneously, investigators will measure gene expression of peripheral blood. Both plasma biomarkers and gene expression profiles will be analyzed using various machine learning techniques, including classification and regression tree, latent class analysis, and hierarchical clustering with the goal of identifying sub-phenotypes of ARDS. These sub-phenotypes will be examined for association with outcome (primary is 28-day mortality), and explicitly tested for variation in response to exogenous treatments (e.g., corticosteroids).

Eligibility Criteria:
Inclusion Criteria:

1. acute (≤ 7 days of risk factor) respiratory failure requiring invasive mechanical ventilation
2. age \> 44 weeks corrected gestational age and \< 17.5 years
3. invasive mechanical ventilation via endotracheal tube
4. bilateral infiltrates on chest radiograph
5. oxygenation index (OI) ≥ 4; or oxygen saturation index (OSI) ≥ 5 on 2 consecutive measurements at least 4 hours apart but \< 24 hours apart
6. invasively ventilated ≤ 7 days before meeting above radiographic and oxygenation criteria

Exclusion Criteria:

1. weight \< 3 kilograms
2. cyanotic congenital heart disease (other than Patent Foramen Ovale (PFO) or Patent Ductus Arteriosus (PDA))
3. tracheostomy at time of screening
4. invasively ventilated for \> 7 days when meet ARDS criteria above
5. cardiac failure as predominant cause of respiratory failure
6. primary obstructive airway disease (asthma, bronchiolitis) by judgement of clinician as the primary cause of respiratory failure
7. alternative known chronic lung disease as cause of respiratory failure (cystic fibrosis, eosinophilic pneumonia, interstitial pneumonitis, pulmonary hemosiderosis, cryptogenic organizing pneumonia)
8. severe neurologic morbidity not expected to survive \> 72 hours
9. any limitations of care at time of screening
10. previous enrollment in this study
The Effects of mETHotrexate Therapy on ST Segment Elevation MYocardial InfarctionS (TETHYS Trial)

Experimental studies suggest that anti-inflammatory and immunomodulatory drugs could reduce the inflammatory profile in acute ischemic disease and reduce the area of ischemia. Methotrexate is a drug that has shown promise in ischemic disease in animal studies.

Atherosclerosis and ischemic disease have clear association with inflammation. There is an anti-inflammatory action of methotrexate by increasing adenosine. Experimental studies demonstrate reduction of infarct induced in animals treated with methotrexate. We expect a reduction in the area under the curve of creatine kinase (CK), creatine kinase MB fraction (CK-MB) and Troponin I high sensitive, decreased levels of B-type natriuretic peptide (BNP) and improvement in left ventricular ejection fraction.

Eligibility Criteria:
Inclusion Criteria:

* Age over 18 years;
* Chest pain suggestive of acute myocardial infarction initiated within 12 hours;
* Electrocardiogram with ST-segment elevation greater than or equal to 0.2 mV in at least 2 contiguous leads;
* Choice of primary angioplasty

Exclusion Criteria:

* Prior acute myocardial infarction;
* Prior heart failure;
* Angioplasty in the last 3 months;
* Cardiac arrest or cardiogenic shock;
* History of renal insufficiency (serum creatinine greater than 2.0 mg/dl);
* History of alcohol abuse (consumption equal to or greater than 20 drinks per week);
* Illicit drug use;
* Evidence of rheumatoid arthritis;
* Neoplasia;
* Infectious diseases;
* Prior anemia (hematocrit below 30%);
* Use of anti-inflammatory hormonal or non-hormonal last week;
* Xanthines excessive consumption (more than two and a half cups of coffee or two and a half mate gourds);
* Pregnancy;
* Disagreement with the term of consent;
Regulatory T-cells and Crohn's Disease

Aim: the main aim of this study is to investigate if immune cells (regulatory T-cells, Th17 cells and other immune cell types) or biomarkers can be used to predict the response or lack of response to treatment with Infliximab. If so, characteristics of the immune cells may also unveil the mechanisms behind lack of response to Infliximab.

Design: a prospective, observational study with three arms. In the treatment group, 35 patients with Crohn's disease about to start Infliximab-treatment are recruited. They have blood samples drawn at day 1 before first treatment, after 6 week, and again after 22 weeks of treatment. 12 healthy volunteers serve as a control group. Controls are only investigated once. All treatment and follow-up are according to national guidelines, and data from this study is not used by the clinicians.

Methods: the number of regulatory T-cells and pro-inflammatory T-cells (Th17 cells) is investigated using flow cytometry. From plasma and serum samples, various proteins (biomarkers), such as transforming growth factor beta (TGF-beta) and tumour necrosis factor alpha (TNF-alpha), are measured using immunoassays. Patient data (demographics and medical history) are extracted from various registries.

Primary analyses: patient response to Infliximab treatment is quantified using Harvey Bradshaw Index, and the response is then related to the number of regulatory T-cells, Th17 cells, and biomarker levels at baseline. The exact cut-off for response vs. non-respons will be determined and validated once all data is collected by an assessor blinded for the flow cytometry results and biomarker levels.

Plan for missing data: for patients with missing Harvey Bradshaw Index, we will first try to re-create the score using the patient records (information on well-being, abdominal pain, diarrhea, fistulae/abscesses, and extra-intestinal Crohn manifestations). If this is not possible, an experienced clinician will rate the patient's Infliximab response based on all available patient record data, but blinded for flow cytometry results and biomarker levels.

Eligibility Criteria:
Infliximab group

Inclusion Criteria:

* Crohn's Disease
* Starting Infliximab treatment
* Patient at the gastrointestinal department at Hvidovre Hospital or Køge Sygehus
* Can understand and write Danish
* European ancestry

Exclusion Criteria:

* Not able to consent in an ethical manner (e.g. severe mental illness)
* Significant co-morbidity (e.g. cancer, HIV)
* Other immunological disease (e.g. psoriasis)
* Current treatment with biological agents

Healthy controls

Inclusion Criteria:

* No current disease
* No daily drug use
* Can understand and write Danish
* European ancestry

Exclusion Criteria:

* Not able to consent in an ethical manner (e.g. severe mental illness)
* Significant co-morbidity (e.g. cancer, HIV)
* Other immunological disease (e.g. psoriasis)
* Current treatment with biological agents
Managing AsThma AnD Obesity Related Symptoms (MATADORS) Feasibility Study

The purpose of this 4 week pilot study is to test the use of a mobile application (also commonly referred to as an app) designed to help increase self-management strategies among youth that have asthma and obesity. The data obtained from this study will facilitate refinement of the app and interventional approaches for a future larger scale study to increase youth self-management of their clinical conditions, symptom management, and health maintenance as they transition to adulthood.


Eligibility Criteria:
Inclusion Criteria:

* Youth-Caregiver Dyad Inclusion Criteria:

  * Male and female youth aged 10 - 17 years
  * Adult primary caregiver (18 years and older)
  * English speaking
  * Youth diagnosis of asthma
  * Prescribed inhaler treatment for asthma
  * Youth Body Mass Index at or above the 85th percentile for age and sex based on the Centers for Disease Control (CDC) growth charts
  * Must own a smartphone (iOS) with working Wi-Fi access and/or cellular data plan
  * Prescribed inhaler treatment for asthma

Exclusion Criteria:

* Diagnosis of cognitive impairment
* Inability or unwillingness of youth participant to assent and/or primary caregiver/legal guardian/representative to give informed consent
* Inability or unwillingness to participate in the audio recording interview session or complete study procedures