cyrilzakka/clinical-trials huggingface dataset:
FIRE AND ICE Re-Ablations (Retrospective Data Collection)

Retrospective data collection on re-ablations performed within the FIRE AND ICE Trial.

The purpose of this retrospective data collection on re-ablations performed in both treatment arms (Cryo arm and Radiofrequency arm) of the FIRE AND ICE Trial is to gain insight into re-occurrence of atrial arrhythmias resulting in a re-ablation after a performed index ablation procedure. Data to be collected from subject charts include pulmonary vein anatomy, documented atrial arrhythmias prior to re-ablation, pulmonary vein reconnection, pulmonary vein ablation lesion gaps and gap location, ablation lesions performed during the re-ablation, procedure parameters of the RF or cryo catheter utilized during the re-ablation, and success of re-ablations performed.

Eligibility Criteria:
N/A - no new patients will be enrolled within this project.

Inclusion Criteria for the FIRE AND ICE Trial included:

* Symptomatic paroxysmal atrial fibrillation (PAF) with at least two episodes and at least one episode documented (30 seconds episode length, documented by electrocardiogram (ECG) within last 12 months
* Documented treatment failure for effectiveness of at least one anti-arrythmic drug (AAD Type I or III, including Beta-Blocker and AAD intolerance)
* 18 to 75 years of age
* Patients who are mentally and linguistically able to understand the aim of the trial and to show sufficient compliance in following the trial protocol
* Patient is able to verbally acknowledge and understand the associated risks, benefits, and treatment alternatives to therapeutic options of this trial: cryoballoon ablation system or standard radiofrequency (RF) ablation technique.

The exclusion criteria were grouped as follows in the FIRE AND ICE Trial:

* General exclusion criteria
* Exclusion criteria related to the cardiac condition
* Exclusion criteria based on laboratory abnormalities
Study to Gain Information on the Drug Xarelto for the Prevention of Brain Attack and Blockage of an Artery in the Non-central Nervous System Due to Irregular Heartbeat in Taiwanese Patients Suffering From Decreased Renal Function

In this study researchers want to learn more about on the safety of the drug Xarelto. The study will enroll patients for whom the treating doctor are prescribing Xarelto for the prevention of brain attack or the prevention of blockage of an artery in the non-central nervous system. Only patients suffering from decreased renal function and irregular heart beat will be considered. The study plans to include 500 Taiwanese adult male and female patients with the age above 20 years. Patients will be followed up based on routine medical practice over a period of 12 months and information on their well-being and any medical events will collected.


Eligibility Criteria:
Inclusion Criteria:

* Female and male patients ≥ 20 years of age
* Diagnosis of non-valvular atrial fibrillation (NVAF)
* Patients for whom the decision to initiate treatment with rivaroxaban is made as per physician's routine treatment practice
* Previously documented CrCl of 15-50 mL/min within 6 months before enrollment (last available value)

Exclusion Criteria:

* Contraindications for rivaroxaban according to the local market authorization/ Summary of Product Characteristics
* Patients participating in an investigational program with interventions outside of routine clinical practice.
* Planned treatment with other anticoagulants
* Expected renal-replacement therapy within the next 3 months
Effects of Brassica or Indole-3-carbinol on Prostatectomy Patients With PSA Recurrence

Pilot and feasibility diet and phyto-agent intervention among healthy men at risk for prostate cancer progression.


Eligibility Criteria:
Inclusion Criteria:

* Men with PSA recurrence following prostatectomy

Exclusion Criteria:

* Not using exogenous hormones
Autoantibody Specificity and Response to IVIG in ITP

The objective of this human study was to evaluate the association between the specificity of anti-platelet autoantibodies and response to IVIG treatment.

Immune thrombocytopenia (ITP) is a common autoimmune bleeding disorder, in which platelet surface GPIIb/IIIa and GPIb/IX are the two most frequently targeted autoantigens. Our previous studies in animal models of ITP demonstrated that intravenous immunoglobulin G (IVIG) could protect against anti-GPIIb/IIIa-mediated thrombocytopenia but failed to ameliorate ITP induced by most anti-GPIb/IX antibodies. The objective of this human study was to evaluate the association between the specificity of anti-platelet autoantibodies and response to IVIG treatment.

Eligibility Criteria:
Inclusion Criteria:

* (1) the diagnosis of ITP was based on the presence of isolated thrombocytopenia and the absence of any obvious initiating and/or underlying cause of the thrombocytopenia in accordance with the recently released international consensus guidelines,(2) a diagnosis was established during the 4 weeks prior to initiation of IVIG treatment, (3) age ≥ 18 years, (4) a platelet count of ≤ 20 × 109/L, and (5) a bleeding score ≥ 9 at the time of admission according to the clinical scoring system described by Khellaf et al. to assess the severity of hemorrhage.

Exclusion Criteria:

* a history of any ITP-specific treatment administered prior to or concomitantly with the IVIG
Osteopathic Intervention in Professional Handball Players

The aim is to study the effectiveness of a common osteopathic intervention in professional handball players on diaphragmatic contractility and its correlations with posture. This study has never been done in healthy subjects. It is a scientific process of objectification of an osteopathic technique commonly performed in this population. The main objective is to assess diaphragmatic contractibility using ultrasound after abdominal osteopathic intervention (OMT).

The context is that of optimizing the performance of professional handball players. The aim is to study the effectiveness of a common osteopathic intervention in professional handball players on diaphragmatic contractility and its correlations with posture. This study has never been done in healthy subjects. It is a scientific process of objectification of an osteopathic technique commonly performed in this population.

The main objective is to assess diaphragmatic contractibility after abdominal osteopathic intervention (OMT).

The secondary objective is to evaluate the impact of this manual intervention in professional handball players on:

* other diaphragmatic ultrasound data
* on spirometry
* postural control

Prospective pilot non-interventional controlled monocentric study opened in healthy male and female International players who are part of the French Handball team. Approach to objectification of current practice.

Eligibility Criteria:
Inclusion Criteria:

* healthy male and female International players who are part of the French Handball team

Exclusion Criteria:

* history of thoracic or diaphragmatic surgery
Dose-Response in PD and Safety of Cofact Under VKA Anticoagulation

This is a randomized, open label, placebo-controlled, parallel design, single center, prospective study. Subjects will receive treatment with VKA. Subjects who reach the targeted INR, will receive single dose of Cofact. Multiple coagulation laboratory tests will be evaluated over a period of 15 days


Eligibility Criteria:
Inclusion Criteria:

* Male or female of nonchildbearing potential.
* Healthy subjects.

Exclusion Criteria:

* Evidence of coagulation disturbances, or disposition for thrombo-embolic events
* Liver function tests more than 1.2 times the upper normal limits
* Participants with thyroid disorders as evidenced by assessment of TSH levels outside the normal reference range at screening.
* Prior history of thromboembolic complications including those in first degree relatives.
* Glomerular filtration rate (GFR) is lower than estimated GFR 62 mL/min/1.73 m2 using the Modification of Diet in Renal Disease Study equation.
* Anaphylactic or systemic reactions to human plasma, plasma products, or blood products.
* History of hypersensitivity to active or inactive excipients of VKA
* Gastrointestinal disease that may impair VKA absorption..
* Participation in another clinical study \<30 days prior to study entry.
* Any clinically significant history of or current clinically significant disease or disorder as judged by the Investigator.
* Positive nasopharyngeal PCR test for SARS-CoV-2 on Day -11 or Day -1.
* Positive pregnancy test at screening, Day -11, or Day -1.
Mindfulness Based Cognitive Therapy for Recurrent Depression

The purpose of this study is to investigate the effectiveness and possible mediating factors of Mindfulness Based Cognitive Therapy (MBCT) for recurrent depression.

Mindfulness Based Cognitive Therapy (MBCT) is a 8 session group intervention and is well described by several authors.

Previous studies showed Mindfulness Based Cognitive Therapy (MBCT) to be effective to prevent relapse in patients with recurrent depression and 3 or more previous depressive episodes.

Study aims are:

1. to replicate previous findings in The Netherlands, by a research team which did not develop the intervention
2. to investigate if MBCT is applicable for patients with recurrent depression and current depressive symptoms
3. to examine possible mediators of treatment effect and predictors of relapse in the year following the treatment

In this study, patients are randomly assigned to a MBCT intervention group or a waiting list control group. Patients allocated to the waiting list control condition will receive the MBCT course three months later. All patients who participated in a MBCT training will be assessed during the year following the completion of the MBCT course. We aim to include about 220 patients.

Eligibility Criteria:
Inclusion Criteria:

* 3 or more previous depressive episodes
* if treated with medication: constant dose of at least 6 weeks

Exclusion Criteria:

* Bipolar Disorder
* Psychotic disorder
* Neurological or somatic illness affecting depression or outcome measures
* Current alcohol or drugs dependency
* Acute need of psychiatric treatment
A Postpartum Adaptation Study of the Connecting and Reflecting Experience Parenting Program

Experiencing postpartum mood and/or anxiety disorders (like postpartum depression; PMADs) can make parenting challenging, but group therapy may help both these parents and their babies. This study will test whether postpartum parents with PMADs find a 12-session parenting group therapy to be likable, doable, and helpful for mental health, parenting stress, and relationship with their infant. The therapy that is being tested is called the Connecting and Reflecting Experience (CARE) parenting program, which has not yet been used specifically with postpartum parents with PMADs, but has been found to be appealing and helpful among parents/caregivers of older children with mental health conditions. CARE focuses on parents' ability to consider how their own and their children's thoughts, feelings, intentions, and other mental states shape behavior and parent-child relationships. Participants in the study will be asked to fill out surveys before, during, and after participating in the group therapy. Adults may be eligible to participate in the study if they gave birth to an infant who is now 3 to 12 months old, are receiving postpartum medical and/or mental health care at Montefiore Medical Center, and have experienced postpartum depression and/or anxiety.


Eligibility Criteria:
Inclusion Criteria:

* Birthing parent (of any gender) of an infant age 3-12 months old at baseline
* Receiving postpartum OB/GYN or mental health services at Montefiore Medical Center
* Experienced or currently experiencing moderate to high levels of depression and/or anxiety symptoms in the postpartum period
* English-speaking

Exclusion Criteria:

* Prior participation in a Connecting and Reflecting Experience (CARE) group at any time
* Participation in another parenting-focused group during the current postpartum period
* Current episode of psychosis or mania
* Psychiatric, neurocognitive, or substance use related difficulties necessitating a higher level of care than outpatient support (e.g., current inpatient treatment) or that would impede group participation (e.g., severe cognitive impairment)
Surgical Treatment of Tricuspid Valve Regurgitation in Patients With Cardiac Implantable Electronic Devices: Long Term Results

Old trials aimed to evaluate Implantable Cardioverter-Defibrillator (ICD) safety and efficacy demonstrated a meaningful decreased rates of sudden death but an increased rate of hospitalization for heart failure . At the time, the chance that an endocardial lead could cause a significant tricuspid regurgitation (TR), leading to worsening heart failure, was not widely considered. Whereas, it is now well established that in patients with cardiac implantable electronic device (CIEDs), moderate or severe TR occurs frequently and it is associated with increased mortality and hospitalization for heart failure.

The present study aims to report the long-term results of tricuspid valve repair and replacement surgery in patients with CIEDs Indeed, patients with TR and CIEDs can be divided in 2 categories: CIEDs induced TR and CIEDs associated TR. In patients with CIEDs induced TR, the valve dysfunction is directly caused by the lead with several mechanism such as mechanical interference with tricuspid valve (TV) leaflet mobility and coaptation (impingement), valve damage during lead placement or manipulation and sub-valvular entanglement. In patients with CIEDs associated TR the valve dysfunction is not directly caused by the lead.

In 2009 approximately 720 000 CIEDs were implanted worldwide \[7\] and since then a continuous increase of CIEDs implantation was registered, with an estimation of 1.4 millions of CIEDs implantation in 2023. With this impressive number of CIEDs requirement, the need for surgical or trans-catheter treatment of severe TR CIEDs induced or associated, increased steadily in the past years and it likely will continue to increase in the next years. However, limited data are available regarding the outcome of tricuspid valve surgery in patients with CIEDs, particularly for the long-term results. With this study we aim to report the long-term result of tricuspid valve repair and replacement in patients with CIEDs.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients;
* Patients with significant, surgically treatable tricuspid regurgitation (TR) according to guidelines
* Patients with an implantable electronic heart device (CIEDs)
* Patients undergoing surgery, both repair or replacement, of the tricuspid valve, both isolated or associated with intervention on the valves of the left heart sections.
* Patients operated at the Cardiac Surgery Department of the San Raffaele Hospital from 2000 to 2019.

Exclusion Criteria:

* Patients without a CIED
Electroacupuncture Modulates SPMs Metabolism and Respiratory Symptoms in Patients With Sepsis Complicating ARDS

In this interventional clinical trial, researchers will administer electroacupuncture versus sham electroacupuncture to sepsis patients with ARDS and collect objective outcome measures. The study will be divided into 2 groups. The EA group will receive electroacupuncture and the SHAM-EA group will receive sham electroacupuncture. The purpose of this study is to investigate the effect of electroacupuncture on the synthesis of SPMs in sepsis patients with ARDS.


Eligibility Criteria:
Inclusion Criteria:

1. Males or females over the age of 18;
2. Diagnosis meets SPESIS 3 criteria for sepsis;
3. The diagnosis meets the Berlin diagnostic criteria for ARDS;
4. ARDS was diagnosed within 48h;
5. Capable of understanding the purpose and risk of the study;
6. Patients or proxy must give written informed consent before any assessment is performed.

Exclusion Criteria:

1. ARDS was diagnosed 48h later;
2. Pregnancy, lactation or perinatal period;
3. malignant tumor;
4. Severe liver failure or kidney failure;
5. Predicted mortality risk of patients within 24h\>80%;
6. Severe end-stage lung disease;
7. ECMO patients are undergoing implementation;
8. HIV seropositive or Syphilis seropositive;
9. Any clinical-relevant condition that might affect study participation and/or study results;
10. Participation in any other intervention trial;
11. Unwillingness or inability to following the study protocol in the investigators opinion.
Systematic Screening With Electrocardiogram for Unknown Atrial Fibrillation in 65 Years Old and Above People in Nursing Home

Atrial fibrillation is the most common arrhythmia. Some studies shown that systematic screening with electrocardiogram could improve atrial fibrillation detection. No studies are available in nursing home. The goal of this study is to screen atrial fibrillation in patients who live in nursing home.

A prospective observational cross sectional multicenter study.

The goal of this study is to detect atrial fibrillation in nursing home people aged 65 years old and above, with systematic electrocardiogram. Participants agreement will be collected. Participants characteristics data will be collected in all nursing home. For all participants, one visit were realised with electrocardiogram, and symptoms survey. Data were anonymised on each center before analysed.

Eligibility Criteria:
Inclusion criteria :

* Being in nursing home since 1 month and above
* Aged \> 65 years old
* Subjects agree to participate at this project

Exclusion criteria :

* Antecedent of atrial fibrillation
Effects of Botanical Microglia Modulators in Gulf War Illness

The overall objective of this protocol is to test if Gulf War Illness (GWI) involves chronic inflammation that cannot be measured with typical techniques. The investigators will be observing the effects of nine different botanical compounds (supplements) that are known to suppress inflammation. If one of those supplements helps the symptoms of GWI, it will give the investigators information about what is wrong in people with GWI.

There is still a poor understanding of the pain, fatigue, and other symptoms that affect approximately 250,000 veterans. The precise mechanism of Gulf War Illness (GWI) is not understood, and there is no targeted treatment for the condition. A current model for GWI points to the central nervous system, immune cells, called microglia that may be hyperactive in patients with GWI. Discovering effective treatments for this disorder is a top priority of GWI research.

Given the investigator's preliminary data, it is suspected that GWI is a form of low-level neuroinflammation that involves hypersensitivity of receptors on microglia. In order to help test that hypothesis, the investigators will be administering supplements that have been shown in vitro or animal in vivo to suppress microglia function in a way that is anti-inflammatory and neuroprotective. If any of these agents suppress symptoms in GWI, it will give the investigators important information about the disease that may allow for creation of better diagnostic tools and treatments in future research studies. Observing the effects of the selected nine anti-inflammatory botanical compounds, in this clinical study, is a strong compliment to the ongoing mechanistic GWI research.

Eligibility Criteria:
Inclusion Criteria:

1. Male
2. Age 39-65, inclusive
3. Veterans who meet the Kansas inclusion criteria for GWI
4. Present in Persian Gulf between 1990 and August 1991
5. Patient completes daily report during 2 week baseline period (at least 80% completion rate)
6. Able to receive a venous blood draw

Exclusion Criteria:

1. Positive rheumatoid factor at screening
2. Positive anti-nuclear antibody at screening
3. C-reactive protein\> 3mg/L at screening
4. Erythrocyte Sedimentation Rate\> 40mm/hr at screening
5. Auto-immune disorder
6. Diagnosed Rheumatologic Condition
7. Major PTSD symptoms
8. Hypotension (under 90/60 mm Hg) or history of cardiovascular disease
9. Antihypertensive, anticoagulant medication, nitroglycerine, lithium medication use
10. Diabetes with Hemoglobin A1C \>9%
11. History of anaphylaxis to study botanical compounds
12. Current daily use of opioid medication
13. Hospital Anxiety and Depression Scale, Depression subscale score of 16 or higher at baseline
14. Current litigation of worker's compensation claim
15. Blood or clotting disorder
16. Acute infection (body temperature over 100 degrees F)
17. Current daily use of confounding-anti-inflammatory medication as part of regular medication regimen
18. Individuals that are not able to read \& understand English
Ultrasound-Assisted Lumbar Puncture

Although the lumbar puncture is a common procedure and has been performed without ultrasound for decades, other research studies suggest that there may be some benefits to using ultrasound. This study intends to see whether by using ultrasound there is increased success rate, decreased need for additional procedures, and less discomfort during the procedure.


Eligibility Criteria:
Inclusion Criteria:

1. Patients who registered for an emergency or inpatient encounter between 5/22/2017 and 5/08/2018
2. Males or females 18 years of age or older
3. Patients who have been identified as requiring a lumbar puncture for any therapeutic or diagnostic or therapeutic indication, as decided by the neurology staff physicians, residents, or advanced practice providers.

Exclusion Criteria:

1. Patients who are not capable of providing consent for participation in research and do not have an authorized relative or power of attorney to consent in their stead.
2. Patients who require lumbar puncture in an emergency, time dependent fashion and in whom a possible delay could conceivable have a negative clinical impact.
3. Patients with known abnormal lumbar spinal anatomy or prior extensive surgical fusion such that fluoroscopic or CT guidance is determined to be more clinically appropriate by the treating physicians.
4. BMI greater than 60
5. Absolute contraindication to lumbar puncture such as uncorrected coagulopathy