cyrilzakka/clinical-trials huggingface dataset:
Predictive Factors for Successful Outcome After Pulmonary Veins Ablation to Treat Paroxysmal Atrial Fibrillation

Atrial fibrillation is the most common serious abnormal heart rhythm affecting about 2% to 3% of the population, being associated with a 1.5- to 1.9-fold higher risk of death. Patients with paroxysmal AF in whom antiarrhythmic drug therapy does not elicit a response are potential candidates for RF ablation of AF. The success rate of RF ablation in the treatment of AF varies depending on the type and duration of AF (ie, paroxysmal vs persistent), structural remodeling of the heart, co-morbidities and the technique of the cardiac electrophysiologist, but it usually ranges from 60-80% over 1-2 years of follow-up.

To study and predict the successful outcome of RF ablation is of great clinical importance. Moreover, the detection of predictive factors for successful outcome may alter the therapeutic strategy determining a subgroup of patients in the need of more invasive management.

The study will include 150 patients scheduled to undergo pulmonary vein (PV) ablation because of non-responsive to medical therapy PAF. ECG recordings will be obtained during sinus rhythm before and after PV ablation with a 3 - channel digital recorder for 10 minutes, and digitized with a 16-bit accuracy at a sampling rate of 1000 Hz. The P wave will be analyzed using the Morlet wavelet. Other parameters to be analyzed include 12 lead surface ECG, the burden of main and secondary morphologies and echocardiographic indexes of left atrial mechanical function. Follow-up visits will be held in 3, 6 and 12 months after the ablation procedure.

Eligibility Criteria:
Inclusion Criteria:

* Males and Females
* Age \>18 years
* Paroxysmal AF (PAF) scheduled to undergo pulmonary vein (PV) ablation
* Singed written consent form
* Patients who will comply with study procedures

Exclusion Criteria:

* Age \<18 years Permanent atrial fibrillation
* Acute myocardial infraction, coronary artery bypass graft surgery or percutaneous transluminal coronary angioplasty within less than 2 months prior to ablation procedure
* Life expectancy less than 12 months, according to investigator's judgment
* Participation to other clinical trial
* Patients who will not be compliant with study procedures
Oral Microbiome is Associated With the Response to Chemoradiotherapy in Initial Inoperable Patients With Esophageal Squamous Cell Cancer

Esophageal cancer accounts for more than half of the world, seriously affecting people's health in China. 95% patients are squamous cell carcinoma. Surgery is the preferred treatment for early and middle stage esophageal cancer, but patients with clinical stage T4b or other surgical contraindications have no surgical opportunity. In recent years, radical chemoradiotherapy has played a key role in the treatment of local advanced esophageal cancer with some poor predicting biomarkers. Oral bacteria may play a pathogenic role in cancer and other chronic diseases by producing chemical carcinogens and inflammatory factors through direct metabolism. A large number of studies have also suggested that tooth loss and poor oral hygiene are closely related to upper digestive tract cancer, indicating the possible role of oral microorganisms in the occurrence and development of upper digestive tract cancer, and saliva is the main source of oral flora colonization. Therefore, it is worth further research to explore the interaction between microbial metabolism imbalance and radiotherapy in patients with esophageal cancer. In summary, we intend to conduct a prospective cohort study to explore the role of salivary microbes in radiotherapy in patients with initially inoperable patients with local advanced esophageal cancer.


Eligibility Criteria:
Inclusion Criteria:

* 18-85 years old;

  * Eastern Cooperative Oncology Group (ECOG) 0-2;
  * Esophageal squamous cell carcinoma;
  * cT2-4aN0-3M0 (AJCC 8th) confirmed by radiological examination;
  * initial unresectable at initial diagnosis confirmed by thoracic surgeons;
  * Treatment naive;
  * No contraindications for adjuvant chemoradiotherapy;
  * Signature of inform consent.

Exclusion Criteria:

* • younger than 18 years old or older than 85 years old;

  * ECOG\>2;
  * Esophageal adenocarcinoma, small-cell cancer and other pathological types;
  * cT1anyNM0, cT4banyNM0, c anyTanyNM0 confirmed by radiological examination;
  * Resectable at initial diagnosis confirmed by thoracic surgeons;
  * Previous treatment of chemotherapy, radiotherapy, and other treatment;
  * Contraindications for chemoradiotherapy;
  * No signature of inform consent.
BCMA-CAR-T in Relapsed/Refractory Multiple Myeloma

Evaluation of the safety and efficacy of BCMA nanobody CAR-T cells in relapsed/refractory myeloma

There are no effective regimens for relapsed/refractory myeloma. BCMA express extensively in mature B cells and plasma cells. Myeloma cells express BCMA universally. BCMA signal pathway can induce plasma cell proliferation and survival, down-regulation of BCMA could control the progression of myeloma. The BCMA CAR used in this study consists of BCMA nanobody, CD8 hinge, transmembrane region and 4-1bb co-stimulation domain.

Eligibility Criteria:
Inclusion Criteria:

* 18 and ≤70 years old and the expected lifetime \>3 months

  * Active myeloma according to IMWG criteria, and BCMA positive by immunohistochemistry or flow cytometry
  * No effective treatment option available
  * ECOG score 0-2
  * Sufficient heart, liver, kidney function (heart: no heart disease or coronary heart disease, patient heart function NYHA grade 1-2; liver: TBIL ≤ 3ULN, AST ≤ 2.5ULN, ALT ≤ 2.5ULN; kidney: Cr≤ 1.25ULN);
  * smoothly peripheral superficial veins
  * No other serious diseases that conflict with this protocol (eg, autoimmune diseases, immunodeficiency, organ transplantation)
  * No history of other malignancies
  * Women of childbearing age must be negative for blood pregnancy test within 7 days and must take appropriated contraceptive measures during and 3 months after the study
  * The patient himself agrees to participate in this clinical study and signed the "informed consent"

Exclusion Criteria:

* Severe infectious 4 weeks before enrollment
* Active hepatitis B or C viral hepatitis, HIV,
* Severe autoimmune disease or immunodeficiency disease
* Severe allergies
* Severe mental disorder
* Patients who used high-dose glucocorticoids within 1 week
* Participation in other clinical studies in the past 3 months or having been treated with other gene products
Monitoring and Evaluation Study of Project ECHO for ILD

The study will utilize pre-post survey measures to evaluate Project ECHO for ILD with respect to an initial set of practice and clinical outcomes and relies on questionnaire data obtained from providers participating in Project ECHO for ILD at baseline, at 6 months, and at study end.

Project ECHO (Extension for Community Healthcare Outcomes) is a knowledge-sharing model to expand the capacity of the health care workforce so that more people can get high quality care for their health conditions in or near the communities where they live. The model brings specialty disease expertise to community providers through its hub-and-spoke networks. The model relies on videoconferencing to connect local providers in non-urban or underserved communities (spoke sites) with an interdisciplinary team of specialist providers at academic medical centers (hubs) during virtual "teleECHO" clinic sessions, which include brief educational lectures and case-based, experiential learning. It is a guided, technology-enabled collaborative practice model in which community providers become experts in an area of community need within the scope of their practice, operating with increasing independence as their skills and self-efficacy grow. The model establishes meaningful, ongoing relationships with hub specialists who serve as telementors for spoke providers and relies on case-based learning from presentations of real-world de-identified patient cases.

The overarching goal of the project is to implement and evaluate an adaptation of the ECHO model to interstitial lung disease (ILD) diagnosis and care among primary care physicians (PCPs) and community pulmonologists in non-urban or underserved communities.

Eligibility Criteria:
Inclusion Criteria:

* Pulmonologists and primary care physicians who participate in Project ECHO for ILD.

Exclusion Criteria:

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Psychological Intervention Mobile App for Patients With AML

This research study is evaluating the impact of a psychological intervention mobile application (app) on the quality of life, mood, and symptoms of patients with acute myeloid leukemia (AML).

Patients with a new diagnosis of AML often confront a sudden and life-threatening diagnosis, requiring an immediate disruption of their life and an urgent 4-6 week hospitalization to initiate intensive chemotherapy. During this hospitalization, they endure substantial physical symptoms due to the side-effects of intensive chemotherapy, which negatively impacts their quality of life (QOL). Patients with AML also experience significant psychological distress as they struggle with the abrupt onset of illness, uncertainty regarding their prognosis, physical and social isolation during their hospitalization, and complete loss of independence. The study doctors want to know if the use of a mobile application (app) focused on helping patients cope with the diagnosis and treatment can reduce the distressing symptoms and improve the their quality of life and care.

The main purpose of this research study is see if a mobile app is feasible to use for patients with new diagnosis of AML and is acceptable to them. The study will also compare two types of care - standard leukemia care and standard leukemia care with the mobile app to see which is better for improving the experience of patients newly diagnosed with AML undergoing treatment.

The purpose of this research study is to find out whether using the mobile app that is focused on educating patients about leukemia and how to cope with its treatment can improve the physical and psychological symptoms that patients experience during hospitalization for their leukemia care. Using this research, the study doctors hope to find out the best way to help patients cope with their diagnosis and treatment for acute myeloid leukemia.

The study will use questionnaires to measure patient's quality of life, physical symptoms, mood, and the participant sense of control over their situation. Study questionnaires will be completed in the hospital or clinic with assistance provided as needed. The participants will also have the option of completing these questionnaires remotely through a secure web link or through a mailed paper copy

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (≥18 years).
* New diagnosis of acute myeloid leukemia.
* Admitted to Massachusetts General Hospital for intensive induction chemotherapy requiring 4-6-week hospitalization.
* The ability to provide informed consent.
* Ability to comprehend and speak English.

Exclusion Criteria:

* Significant uncontrolled psychiatric disorder (psychotic disorder, bipolar disorder,
* Major depression) or other co-morbid disease (dementia, cognitive impairment), which the treating clinician believes prohibits the ability to participate in study procedures
Vasopressor Preload Modulation During General Anaesthesia

Is is debated whether administration of pure vasopressor may augment cardiac output (CO) by means of preload modulation. We wish to test this in 20 patients under general anesthesia, with preload dependency induced by head-up-tilt and preload modulation with infusion of phenylephrine. To document any changes in CO the patients will be monitored by Lithium dilution method. Furthermore we will monitor changes in peripheral perfusion index and test the ability of this non-invasive modality to track changes in CO.


Eligibility Criteria:
Inclusion Criteria:

* Planned surgery under general anesthesia

Exclusion Criteria:

* atrial fibrillation
* refusal to participate
Effect of Iloprost on Pulmonary Oxygenation in Patients With Low Diffusing Capacity During One-lung Ventilation

One lung ventilation (OLV) is essential during thoracic surgery. During OLV, intrapulmonary shunt can be increased resulting hypoxemia. Although OLV technique had been advanced so far, hypoxemia during OLV reaches about 10% in spite of inspired oxygen fraction 100%. Iloprost is a prostaglandin analogue used for pulmonary hypertension, which can decrease pulmonary artery resistance by selectively dilating pulmonary artery. In this prospective, randomized, double blind study, investigators are planning to investigate the effects of iloprost on respiratory physiology (intrapulmonary shunt, deadspace, oxygenation, etc).


Eligibility Criteria:
Inclusion Criteria:

* scheduled for Video-assisted thoracoscopic surgery (VATS) lobectomy
* 40 \< age \< 80
* American Society of Anaesthesiologists (ASA) physical status classification I\~III
* diffusing capacity (DLCO) \<75% at pre op. pulmonary function test

Exclusion Criteria:

* American Society of Anaesthesiologists (ASA) physical status classification IV
* New York Heart Association (NYHA) class III\~IV
* Severe obstructive lung disease and/or restrictive lung disease patients
* patients with end-organ diseases (i.e. heart failure, respiratory failure, hepatic failure, renal failure)
* arrhythmia
* pregnant women
* disease that can influence the DLCO result (anemia, pulmonary vascular disease)
The Electroencephalogram and Clinical Effect of Ketamine

The electroencephalography (EEG) is a noninvasive medical technique for monitoring and recording the electrical activity of brain. The Hilbert-Huang Transformation (HHT) was proposed to decompose EEG signal into intrinsic mode functions (IMF). HHT can obtain instantaneous frequency data and work well for nonstationary and nonlinear data. We applied this method in perioperative EEG signal analysis in order to find the energy shift and quantify the energy change during general anesthesia. Ketamine was a depolarized sedative which was wildly used in anesthesia. We are trying to find the energy change after ketamine injection, and the interaction between different oscillations in EEG. The whole brain mapping for ketamine and other sedatives interaction is the next step.

Method: In the first year, we will record 60 patients who received general anesthesia, their EEG data recorded from bi-spectral index (BIS) monitor. Under the same anesthesia depth, the experimental group use ketamine 0.5mg/kg; while the control group using alfentanil 0.01mg/kg injection. Both perioperative data were recorded included heart rate, blood pressure and surgical time. We decompose the raw EEG data from BIS monitor with EMD, and we observe difference between IMFs, and quantifying energy change. Second year: We will extend the EEG monitor to temporal lobe, parietal lobe and occipital lobe. Besides the whole brain mapping method for detecting energy change after ketamine injection; we also tried to find the interactions between oscillations. Finally, we want to apply the analysis method to pediatric patients, try to find the difference of ketamine reaction between generations. Anticipated Results: We anticipate that we can quantify the energy of EEG by Emperical mode decomposition(EMD), and ketamine injection can cause different energy change with other sedatives. We will find the energy traveling in EEG with EMD decomposition. We will find that HHT is more suitable for EEG analysis in clinical practicing. With the whole brain mapping method, we can understand the electrical activity during general anesthesia.

Eligibility Criteria:
Inclusion Criteria:

American Society of Anesthesiology I-II Not allergic to BIS probe Do not have wound or scar over forehead area

Exclusion Criteria:

patient refuse not suitable for propofol or ketamine injection
A Study to Evaluate the Efficacy and Safety of BuMA Supreme Drug Eluting Stent(DES)

PIONEER-II RCT trial is a prospective, multicenter, randomized, non-inferiority registry trial. 539 subjects from about 40 interventional cardiology centers in China will be enrolled to evaluate In-stent late lumen loss(LLL) as the primary endpoint at 9 months. And all the subjects will be followed up to 5 years to attain the data of the secondary endpoints.

Realizing even more uniform and complete endothelial coverage, BuMA Supreme™ biodegradable drug coating coronary stent system comprises a new generation of biodegradable drug eluting stent under development by SINOMED. BuMA Supreme™ reconfigures BuMA™ DES utilizing a high caliber cobalt chromium platform coated with rapidly degrading PLGA scaffold.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18-75, male or non-pregnant female
2. Evidence of non-symptomatic ischemia, stable or non-stable angina pectoris or past MI
3. Target lesion is primary and de-novo coronary artery disease
4. The target lesion length ≤ 60 mm, diameter 2.25mm-5.0mm (visually estimated)
5. Lesion diameter stenosis ≥70% (visually estimated)
6. For each target lesion, same stent implantation only
7. Acceptable candidate for coronary artery bypass grafting (CABG)
8. Understand the study purpose, willing to participate and sign the letter of consent, agrees to the follow-up visits including a 9 month angiographic follow-up

Exclusion Criteria:

1. Acute MI within 1 week
2. Chronic total occlusion(TIMI 0), left main lesion, intervention-required three-vessel lesions, branch vessel diameter ≥ 2.5mm and bypass lesion
3. More than 3 stents required
4. Patients refuse to be implanted stent
5. Calcified lesion failed in pre-dilation, twisted lesion and lesion unsuitable for stent delivery and expansion
6. In-stent restenosis
7. Planned percutaneous coronary intervention (PCI) within 3 months post procedure
8. Other stents implanted within 1 year
9. Severe heart failure (NYHA above III) or left ventricle ejection fraction (EF) \<40%
10. Renal function damage, blood creatinine \> 176.82 μmol/L
11. Bleeding tendency, active peptic ulcer disease, cerebral or subarachnoid hemorrhage, cerebral apoplexy within half year and contraindication for any anti-platelet or anticoagulation agents
12. Allergic to drugs or agents used in stent or protocol (PLGA, sirolimus, aspirin, clopidogrel, contrast agent, cobalt, nickel, chromium, iron, wolfram et. al.)
13. Life expectation \< 12 months
14. Have not reached the primary end point when participating in other trial
15. Poor compliance to the protocol
16. Heart implantation cases
Nutritional Status Among Upper Gastrointestinal Cancer Patients Upon Admission

Cross-sectional study. Data on clinical, anthropometric, biochemical profile and dietary intake Upper Gastrointestinal Cancer Patients upon admission are traced and collected.

As per routine care, on the day of admission, nutrition assessment and clinical examination of all in-patients will be carried out. Patient screening will be done by assigned investigator based on the dietitian censes based on inclusion and exclusion criteria. The investigator will trace the data from medical system and record in the data collection form.

Eligibility Criteria:
Inclusion Criteria:

* Admitted UGIC patient
* Seen by dietitian in ward

Exclusion Criteria:

* Not admitted in ward
* Aged \<18 years old
* Non-Malaysian
Accuracy of Fully Guided Versus Half Guided Implant

six implants will be placed in edentulous maxilla to rehabilitate patients with implant prosthesis.The primary outcome measure will be the accuracy of implant placement, which will be evaluated using cone-beam computed tomography (CBCT) scans

Study Design:

This will be a Split mouth randomized controlled trial (RCT) study. 16 patients missing teeth in the maxillary (upper) jaw and eligible for dental implant treatment will be recruited.

Interventions will be randomly assigned to the right or the left side of the arch :

Group 1 will undergo fully guided dental implant surgery. Group 2 will undergo partially guided dental implant surgery.

Study Duration:

The total duration of the study is estimated to be 5 months. Recruitment and enrollment of patients: 1 months Dental implant surgery : 3 months Data analysis and manuscript preparation: 1 months

The key steps are:

Recruit 16 eligible patients missing teeth in the maxillary jaw. Randomly assign right or left side of the maxillary arch of patients to either the fully guided or partially guided implant surgery group.

Perform CBCT (cone-beam computed tomography) scans before and after the implant surgery for both groups.

Assess the accuracy of implant placement in both groups using the CBCT data. Conduct statistical analysis to determine if there are any statistically significant differences in implant placement accuracy between the two groups.

Interpret the results and develop recommendations on the optimal guided surgery technique for rehabilitating the edentulous maxilla using dental implants.

The study aims to provide scientific evidence to guide clinicians in selecting the most appropriate guided surgery approach for maxillary implant rehabilitation

Eligibility Criteria:
Inclusion Criteria:all patients underwent a panoramic X-ray and an oral examination. Inclusion criteria consisted of patients aged 18 years or older with complete edentulism and adequate bone volume to accommodate six standard implant fixtures measuring 3.7 mm in diameter and 10 mm in length. -

Exclusion Criteria:Conversely, patients with partial edentulism, insufficient bone volume for a 3.7 mm diameter and 10 mm length implant fixture, or any local/systemic condition that could impede dental implant surgery were excluded from the study. Additionally, patients who smoked more than five cigarettes per day were also excluded. It is important to note that all patients provided written consent prior to their participation in the study. -