cyrilzakka/clinical-trials huggingface dataset:
Machine Learning in Atrial Fibrillation

Atrial fibrillation is a serious public health issue that affects over 5 million Americans (Miyazaka, Circulation 2006) in whom it may cause skipped beats, dizziness, stroke and even death. Therapy for AF is currently suboptimal, in part because AF represents several disease states of which few have been delineated or used to successfully guide management. This study seeks to clarify this delineation of AF types using machine learning (ML).

This project tests the novel hypothesis that "Machine learning (ML) in AF patients can integrate physiological data across biological scales stratified by labeled outcomes, and use explainability analyses to identify electrical, structural and clinical determinants of ablation outcome in individual patients to guide personalized therapy". We address this hypothesis using a combined computational/clinical approach. The project will recruit 120 patients to address 3 Specific Aims.

Aim 1. To identify components of AF electrograms that indicate depolarization, repolarization or other mechanisms at the tissue level, using ML trained to monophasic action potentials (MAP). For this prospective protocol, we will collect electrograms using a MAP catheter at multiple atrial sites in patients undergoing AF ablation. We will then test if our algorithms developed previously from our registry, can predict MAP timings from AF electrograms.

Aim 2. To identify electrical and structural features of the acute response of AF to ablation near and remote from PVs at the individual heart level using machine learning and biostatistical approaches. For this prospective protocol, we will recruit patients undergoing their standard-of-care ablation and test if an ML classifier developed previously in a registry dataset prospectively predicts acute response to specific ablation strategies.

Aim 3. To identify patients in whom ablation is unsuccessful or successful long-term using ML and biostatistics. For this prospective protocol, we will recruit patients undergoing their standard-of-care ablation and test if an ML classifier developed previously in a registry dataset prospectively predicts 1 year freedom from atrial arrhythmias.

This project is significant because it will establish a deeper understanding of AF and might reveal novel mechanisms of AF maintenance. Our results can be translated directly to practice and may enable the development of better treatment options.

Eligibility Criteria:
Inclusion Criteria:

* undergoing ablation at Stanford of (a) paroxysmal AF (self-terminates \< 7 days), or (b) persistent AF (requires cardioversion to terminate).
* Per our clinical practice and guidelines (Calkins et al, Heart Rhythm 2012), patients will have failed or be intolerant of ≥ 1 anti-arrhythmic drug.

Exclusion Criteria:

* active coronary ischemia or decompensated heart failure
* atrial or ventricular clot on trans-esophageal echocardiography
* pregnancy (to minimize fluoroscopic exposure)
* inability or unwillingness to provide informed consent
* rheumatic valve disease (results in a unique AF phenotype)
* thrombotic disease or venous filters
Develop Novel Methods to Display, Report and Analyze CGM Data for Clinical Decision-Making in People With Diabetes

The purpose of this study is to obtain sufficient continuous glucose monitoring (CGM) data in a manner that provides clinical information that is not available using conventional self-monitored blood glucose. Currently, a formal method does not exist for evaluating CGM data except for looking at each glucose reading across the days a CGM system has been worn and evaluating it based on clinical practice experience. The hope is that a mathematical model can be developed that will enable health care providers to quickly and easily determine what changes in diabetes treatment need to be made after CGM data is obtained.

There are two purposes to the study. First, to use an investigational device, the FreeStyle Navigator Continuous Glucose Monitoring (CGM) System (Abbott Diabetes Care) to obtain sufficient longitudinal data in order to develop a method for reporting CGM data in a manner that provides clinical information that is not available using conventional SMBG. The long-term goad is to determine the manner and degree to which CGM contributes to clinical decision-making. Because of the evidence that glucose regulation may be indirectly related to blood pressure levels, a second purpose of the study is to monitor variation in BP control by means of self-monitored BP.

Eligibility Criteria:
Inclusion Criteria:

* Male or female
* Diagnosed with type 1 or type 2 diabetes
* Treated with insulin therapy
* Can also be taking other diabetes medication treatment
* Age 21 and older
* Willing to give informed consent
* Capable of following the protocol and instructions of study staff
* Available for scheduled visits
* Access to telephone communications

Exclusion Criteria:

* Under 21 years of age
* Unable to follow protocol
* Unable to read and write in English
* Skin abnormalities at insertion sites
* Allergy to adhesives
* Any concomitant medication thay would likely affect evaluation of device
Misoprostol Before Hysteroscopy in Infertile Cases

The role of hysteroscopy in infertility investigation is to detect possible intrauterine changes that could interfere with implantation or growth or both of the conceptus, with the invention of miniature hysteroscope, it is possible to perform hysteroscopy in an office setting (Outpatient hysteroscopy; OH), for diagnostic and certain therapeutic intervention. It is currently acknowledged as the 'gold standard' investigation of the intrauterine abnormalities.

Cervical priming prior to diagnostic hysteroscopy softens the cervix and lessens the force needed for dilation, thereby potentially reducing the probability of procedural complication such as uterine perforation, cervical laceration, failure to dilate, and creation of a false track that can occur during cervical entry.

Misoprostol is a prostaglandin El analogue, that can be administered either orally or vaginally, that can cause cervical ripening by inducing collagenolytic activity and synthesis of proteoglycans.


Eligibility Criteria:
Inclusion Criteria:

* Female patients aged from 20 to 40 years old.
* They are complaining with primary or secondary infertility.
* They undergo investigations including husband semen analysis, hormonal assay, U/S, Hystrosalpingography.

Exclusion Criteria:

* Known sensitivity to misoprostol.
* Any systemic disease contraindicating the use of prostaglandins (cardiovascular disease, hypertension, renal failure, etc).
* Concomitant neurologic disease that could affect the correct evaluation of pain.
* Pregnancy.
* Any contraindication to hysteroscopy such as Pelvic inflammatory disease (PID).
* Heavy uterine bleeding.
* Any uterine abnormality such as pinhole cervix that would obviate passage of a catheter through the cervix.
Clinical Study of CAR-T Cell Therapy Following ASCT for R/R B-cell Non-Hodgkin's Lymphoma

The study is designed to evaluate the efficacy and safety of chimeric antigen receptor T-cell therapy following autologous stem cell transplantation for relapsed/refractory B-cell Non-Hodgkin's lymphoma.

Chimeric antigen receptor T (CAR-T) cell therapy has emerged as a promising approach for relapsed or refractory B-cell Non-Hodgkin's lymphoma (R/R B-NHL), with a complete response (CR) rate of about 50%. It is also considered to be a reasonable consolidation option in low or unmeasurable disease states recently. Unfortunately, 40%-70% of patients experienced relapse after CAR-T cell therapy in the long-term follow up. Autologous stem cell transplantation (ASCT) with myeloablative chemotherapy can enhance the efficiency of CAR-T cells and alleviate tumor load, leading to a lower relapse rate. As a result, CAR-T cell therapy following ASCT may be a promising method for R/R LBCL patients.

Eligibility Criteria:
Inclusion Criteria:

1. Age: 18-65 years.
2. Pathological immunohistochemistry or flow cytometry confirmed that R/ R Large B-cell Non-Hodgkin's Lymphoma with measurable (the longest diameter greater than 1.5cm and the longest vertical diameter greater than 1.0cm) lesions.
3. Previously treated with 1 or more lines of therapy.
4. ECOG≤2#.
5. The main organ functions need to meet the following conditions:LVEF≥50%;CCr≥30 ml/min; ALT and AST≤3 times normal range.
6. Hematopoietic function needs to meet the following conditions: platelet count≥45×10\^9/L; hemoglobin≥8.0 g/dL; absolute neutrophil count≥1.0×10\^9/L.
7. Subjects of child-bearing or child-fathering potential must be willing to practice birth control from the time of enrollment on this study until the follow-up one year period of the study.
8. Estimated survival time ≥3 months.
9. Voluntary signing of informed consent and good compliance.

Exclusion Criteria:

1. Have used immunosuppressants or hormones within 2 weeks prior to apheresis, or have to use immunosuppressants or hormones after signing informed consent.
2. The presence of bacterial, fungal, viral, mycoplasma or other types of infection that, in the judgment of the investigator, are difficult to control.
3. Active hepatitis B or active hepatitis C.
4. HIV infection.
5. Have received CAR-T cell therapy or allogeneic hematopoietic stem cell transplantation prior to signing the informed consent.
6. Prior malignancy (other than Relapsed Refractory B-cell Non-Hodgkin's Lymphoma).
7. Pregnant or breasting-feeding women.
8. There is evidence of complications or medical conditions that could interfere with the conduct of the study or put patients at serious risk, including but not limited to serious cardiovascular disease.
9. Conditions deemed by the researchers to be inappropriate for participation.
Effect of Bristle-less Toothbrush (PeriClean) on Gum Recession

This study tests if a bristle-less tooth brush has any measurable effect on gum recession in patients who are seen regularly for preventive dental care compared to a regular soft tooth-brush.

Subjects are recruited from patients attending the Western University of Health Sciences Dental Center and asked to continue regular preventive dental care while using either the test or control brush for a year and using floss and toothpaste supplied by the researchers. The exams include measurement of plaque, pockets and gum recession every 3 months, and involve photographs and impressions of the teeth and gums to record any changes that occur.

Purpose: This randomized clinical trial tested if a novel bristle-less tooth brush design is more effective in preventing gingival recession in adults receiving periodontal maintenance than a soft tooth brush with nylon bristles.

Materials and methods: The investigators will recruit 23 subjects with gingival recession who received regular periodontal maintenance care at Western University of Health Sciences Dental Center, and who did not exhibit signs of acute dental and systemic disease, occlusal discrepancies and parafunctional habits. The investigators will randomly assign these subjects to two groups, one using a soft nylon-bristled tooth brush, and the other group using the experimental tooth brush that contains a brush head with short, soft, rubbery cones. Both groups will receive regular maintenance and periodontal exams by blinded examiners every 3-4 months measuring probing depth, bleeding on probing, plaque indices, and gingival recession. In addition, gingival recession will also be determined using a measuring guide on study models obtained with polyvinylsiloxane impressions. For added control of confounding variables, both groups will be supplied with abrasivity tooth paste and waxed floss while receiving repeated oral hygiene instruction and phone follow-up.

Eligibility Criteria:
Inclusion Criteria:

* receive regular periodontal treatment at the Western University of Health Sciences Dental Center
* have facial gingival recession with at least 1 mm clinical attachment loss in the anterior region of their mouths

Exclusion Criteria:

* unable to provide consent
* had severe uncontrolled medical conditions resulting in an American Society of Anesthesiologist's Physical Status Class greater than 3
* acute pain or infection
* caries near the gingival margin
* restorations covering the gingival recession defect
* presence of Miller Class III or IV defects
* severe or aggressive periodontitis
* missing more than one anterior tooth
* severe malocclusion
* presence of occlusal trauma requiring more than limited adjustment
* Tobacco use
* ongoing or planned orthodontic therapy
* oral piercings
* history of bruxism, clenching, nail biting, holding pins with teeth, or gum scratching habits
* preferred use of an electric tooth brush over a manual brush
Assessment of Somatic Symptom Burden

The Patient Health Questionnaire-15 (PHQ-15) is a frequently used questionnaire to assess somatic symptom burden. The Somatic Symptom Scale China (SSS-CN) was recently developed as a comprehensive self-report instrument in assessing somatic symptom burden, but its assessment value has not yet been widely tested in a nationwide. The study aims to investigate the reliability of the SSS-CN, to validate discriminate validity and factorial validity, and to investigate its utility in patients with suspected coronary artery disease (CAD) based on multi-centers inpatients.

Somatic symptoms are prevalent in kinds of medical conditions and mental disorders. Since they are associated with decreased quality of life, increased psychological distress, and increased use of health care services, the assessment of somatic symptom burden is essential in evidence based patient care and research. The Patient Health Questionnaire-15 (PHQ-15) is a frequently used questionnaire to assess somatic symptom burden, but in which there are not any mental symptoms listed. Recently, we developed the Somatic Symptom Scale China (SSS-CN) which includes common mental symptoms and more comprehensive somatic symptoms to assess somatic symptom burden, but its assessment value has not yet been widely tested.

The aim of our study is to investigate the reliability and validity of the SSS-CN compared with the PHQ-15. We also try to use the SSS-CN to investigate the prevalence of somatic symptoms in patients with suspected coronary artery disease (CAD) based on multi-centers inpatients.

Eligibility Criteria:
Inclusion Criteria:

1. People who take the physical examination in Renji Hospital.
2. Patients with suspected CAD.

Exclusion Criteria:

1. People who have been previously confirmed serious medical conditions.
2. People who have been previously confirmed serious mental disorders.
Influence Positive End-expiratory Pressure on Autoregulation in Patients With Respiratory Insufficiency

The aim of the present study is to characterize the influence of an elevated positive end-expiratory pressure in patients with acute respiratory distress syndrome or acute lung injury on the cerebrovascular autoregulation.

Cerebral blood flow velocity will be measured using transcranial Doppler sonography and then correlate with the invasive arterial blood pressure curve to calculate the index of cerebrovascular autoregulation Mx (Mx\>0.3 indicates impaired AR). The index of cerebrovascular autoregulation Mx was measured during baseline positive end-expiratory pressure (PEEP) levels and after lung recruitment with higher level of PEEP. The equality between this two PEEP levels was estimated and calculated with one side Wilcoxon test.

Eligibility Criteria:
Inclusion Criteria:

* respiratory failure
* Age \>18 years
* Invasive ventilation

Exclusion Criteria:

* Sepsis
* preexisting cerebral illness
* traumatic brain injury
* meningitis or encephalitis
* pregnancy
Music for Anxiety in Embryo Transfers

The goal of this clinical trial is to compare if playing music before and during an embryo transfer can make a difference for women who are going through a frozen embryo transfer as part of a medical procedure called assisted reproduction technology (ART).

The main questions it aims to answer are:

* Does listening to music before and while having the embryo transfer make patients feel more satisfied and less anxious?
* Does listening to music before and during the embryo transfer affect how likely it is for the woman to get pregnant?

Before the embryo transfer, the participants will listen to music through earphones or speakers. During the embryo transfer, the participants will listen to music through speakers.

During the embryo transfer, the comparison group will not listen to music and will receive the usual care.

The aim is to see if listening to music before and during the embryo transfer can help make the procedure better for women.


Eligibility Criteria:
Inclusion Criteria:

* women undergoing a frozen embryo transfer as a consequence of an ART technique

Exclusion Criteria:

* gestational carriers
* hearing-impaired or deaf persons
* fresh embryo transfers
Post-marketing Surveillance of Long-term Administration of Donepezil Hydrochloride -Investigation of the Clinical Condition and Safety in Patients With Alzheimer's Disease-

The purpose of this study is to investigate the following about donepezil hydrochloride administration in patients with mild or moderate Alzheimer's Disease in clinical practice: cognitive function, Functional Assessment Staging (FAST) score, adverse events/adverse drug reactions, and patient background.


Eligibility Criteria:
Inclusion criteria:

Patients diagnosed with Alzheimer's Disease by Diagnostic and Statistical Manual of Mental Disorders (DSM-IV). Patients diagnosed with mild or moderate Alzheimer's Disease, applicable to FAST score 4 or 5.

Exclusion criteria:

Patients with history of hypersensitivity to component of Aricept or piperidine derivative. Patients registered for this survey before.
The Pharmacokinetics and Pharmacodynamics Between HR011408 and NovoRapid® in Healthy Subject

The objective of the study is to compare the pharmacokinetics and pharmacodynamics between HR011408 and NovoRapid® in healthy subject.


Eligibility Criteria:
Inclusion Criteria:

1. Informed consent obtained prior to any trial-related activities；
2. Male or female subjects aged 18-55 years (both inclusive) at the time of signing informed consent；
3. Body weight ≥50.0 kg for men and ≥45.0 kg for women, with body mass index (BMI) between 18.0 and 26.0 kg/m2 (both ends included)；
4. Are nonsmokers, have not smoked for at least 6 months before entering the study, and agree not to smoke (cigars, cigarettes, or pipes) or not use smokeless tobacco or nicotine products for the duration of the study.

Exclusion Criteria:

1. Have an abnormality in the 12-lead electrocardiogram (ECG) and as deemed to be clinically significant by the investigator;
2. have a significant history of the circulatory system, respiratory system, digestive system, urinary system, hematopoietic system, endocrine and metabolic system, neuropsychiatric system, musculoskeletal system, or existing diseases in the above systems may affect the safety of the subjects and interfere with the study data.
3. In the opinion of the investigator, are unsuitable for inclusion in the study.
Education for Adapted Physical Activity in Parkinson's Disease

Parkinson's disease is a progressive disorders characterized by motor and non-motor symptoms. Actual medical treatments are symptomatic and have little efficacy on late stage axial motor symptoms. Non-pharmacological approaches are therefore essential from the disease onset.

Beside physiotherapy, to practice a regular adapted physical activity is crucial. To implement such a practice in everyday life implies to change habits. Patient Education programs are useful tools to help changing behaviors.

The study evaluate the effect of a program aiming to promote adapted physical activity in early stage Parkinson's disease by comparing patients receiving the program and patients on a waiting list. The hypothesis that the program will increase the one-week mean daily moderate to intense physical activity as measured with an actimeter.


Eligibility Criteria:
Inclusion Criteria:

* suffering from Parkinson's disease according to Movement Disorders Society criteria,
* with a diagnosis of Parkinson for 3 years or less,
* with a stable treatment for Parkinson's disease for 3 months or more,
* having signed the consent form

Exclusion Criteria:

* Woman child-bearing or breath-feeding
* Co-morbidities that influence or contraindicated adapted physical activity (severe respiratory symptoms, cardiopathy...)
* Major depressive disorder according to DSM-V
* Significant cognitive trouble (MOCA\<23)
* Atypical parkinson's
Biomarkers in Bone Marrow Samples From Patients With Acute Promyelocytic Leukemia

This research study is studying biomarkers in patients with acute promyelocytic leukemia. Studying samples of bone marrow from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and about biomarkers related to cancer.

OBSERVATIONAL STUDY MODEL: Case-only TIME PERSPECTIVE: Retrospective BIOSPECIMEN RETENTION: Samples With DNA BIOSCPECIMEN DESCRIPTION: Bone marrow STUDY POPULATION DESCRIPTION: Primary Care Clinic SAMPLING METHOD: Non-Probability Sample

PRIMARY OBJECTIVES:

I. To measure WT1 and VEGF-1 expression in patients with acute promyelocytic leukemia.

OUTLINE: This is a multicenter study.

Patient mRNA samples from diagnosis are analyzed via quantitative PCR to measure WT1 and VEGF-1 expression.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of acute promyelocytic leukemia \[t(15;17) translocation\]
* Not specified
* Not specified
Feasibility Study of the Hemolung Respiratory Assist System

The purpose of this study is to evaluate the safety and efficacy of the Hemolung Respiratory Assist System in patients with hypercapnic respiratory failure associated with acute exacerbation of chronic obstructive pulmonary disease (COPD) and a 50% likelihood of failure of noninvasive positive pressure ventilation leading to intubation and mechanical ventilation.


Eligibility Criteria:
Inclusion Criteria:

* Moderate or severe COPD, as defined by the GOLD criteria
* Acute exacerbation of COPD (sustained worsening of patient's condition necessitating a change in regular medication)
* On non-invasive positive pressure mechanical ventilation \> 1hour with either:
* PaCO2 \> 55 mmHg with pH \< 7.25 OR
* PaCO2 \> 55 mmHg with \< 5mmHg decrease from baseline and pH \< 7.30
* Not severely hypoxemic (PaO2/FiO2 ≥ 200 mmHg on PEEP/CPAP ≤ 5 cmH2O)
* Hemodynamically stable (mean arterial pressure \> 65 mmHg without vasopressor support)
* Chronic arrhythmias (e.g., atrial fibrillation) well controlled
* Minimum platelet count of 100,000/mm3
* Minimum red blood cell count of 2.5 mill/μl

Exclusion Criteria:

* Presence of acute, uncontrolled arrhythmia
* Acute ischemic heart disease
* Presence of bleeding diathesis
* Significant abnormality or weakness/paralysis of respiratory muscles due to a know muscular dystrophy or neurologic disorder
* Recent (\< 7 days) prolonged (\>24 hrs) use of muscle paralyzing agents
* Cerebrovascular accident, intracranial bleed, head injury or other neurologic disorder likely to affect ventilation
* Coma from any cause, or decreased consciousness
* Hypersensitivity to heparin or previous heparin induced thrombocytopenia
* Recent (\< 6 months) major chest abdominal trauma or surgery
* Presence of septic shock
* Presence of a significant pneumothorax or bronchopleural fistula
* History of uncontrolled major psychiatric disorder
* Pregnant women
* Known to have AIDS or to have symptomatic HIV
* Received chemotherapy or radiation within the previous 90 days
* Received an organ transplant other than corneal transplants
* Received or currently receiving immunosuppressive therapy, excluding corticosteroids within the last 3 months
* Presence of severe renal or liver failures
* Known vascular abnormality with could complicate or prevent successful insertion of the vascular access catheter in the right femoral vein
* Presence of another catheter in the right femoral vein that cannot be moved
* Presence of an inferior vena cava filter