cyrilzakka/clinical-trials huggingface dataset:
Adjunctive Right Atrial Ablation for Persistent Atrial Fibrillation With Right Atrial Enlargement

This is retrospective cohort study testing whether patients with persistent atrial fibrillation and right atrial enlargement may benefit from adjunctive right atrial ablation.

This is retrospective cohort study testing whether patients with persistent atrial fibrillation and right atrial enlargement may benefit from adjunctive RA ablation.

We enrolled 65 patients with persistent atrial fibrillation and right atrial enlargement received adjunctive right atrial ablation. These patients were 1:2 match with 130 patients received left atrial ablation only. Atrial fibrillation recurrence rate and other paremeters were analyzed to evaluate the efficacy of adjunctive right atrial ablation in this subset of patients.

Eligibility Criteria:
Inclusion Criteria:

1. Aged 18 to 80 years old;
2. Persistent AF with right atrial enlargement;
3. Nonresponse or intolerance to ≥1 antiarrhythmic drug.

Exclusion Criteria:

1. History of catheter ablation;
2. valvular heart disease;
3. hypertrophic cardiomyopathy or dilated cardiomyopathy;
4. Without follow-up data
Intravenous Anesthesia Versus Anesthesia With Volatile Agents in Elective Craniotomy for Tumors

If the anesthetic regimen can influence the serum level of inflammatory cytokines and if the levels of cytokines are related to the incidence of post operative complications, these complications may be a function of the anesthetic method. In an effort to find the best anesthetic regimen for patients undergoing craniotomy for intracranial tumors, the researchers will compare the effect of volatile anesthetic with that of total intravenous anesthesia (TIVA) on cytokine levels. The researchers will also compare the composite incidence of some common major post-operative complications after craniotomy for intracranial malignancy.

This is a randomized blinded clinical trial. Patients will be randomized into one of two groups. One group will receive a volatile anesthetic (sevoflurane)while the other group will receive intravenous anesthetics (propofol + remifentanil) for maintenance of General Anesthesia.

The anesthesia team will know the result of randomization at induction. Postoperative data will be gathered by research personnel who will be blinded to the anesthetic method used. Patients will be blinded to the anesthetic they receive until after the 4-week outcomes are collected, when they will have the option to be unblinded.

Peripheral blood samples will be taken a total of 7 times; pre-induction to anesthesia, 15 minutes after surgical positioning, after the tumor is extracted, and at 6,12,18, and 24 hours after emergence from anesthesia.

Patients will be called for follow up every week for 4 weeks following discharge.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing general anesthesia for elective surgical excision of a primary brain tumor
* Age: Older than 18
* New and recurrent cases will be included

Exclusion Criteria:

* Patient refusal
* Emergency craniotomy
* Craniotomy after head injuries or intracranial bleeding
* Patients with active inflammatory processes such as infection or immunologic illnesses known to increase baseline immunologic markers
* Preoperative diagnosis of DVT by lower extremity ultrasound or symptoms
* Preoperative pulmonary infiltrative disease (pulmonary fibrosis, sarcoid, etc.)
* Pregnancy
Identification of Potential Biomarkers for Pain

The study investigates the potential of using serum biomarkers to assess pain in fibromyalgia patients.

At the heart of the opioid epidemic is the lack of an objective measure of pain, which will help evaluate the validity of the patients' perception that the current dosage of opioid is sufficient of insufficient to alleviate pain. This study will test the quantifiable proteins such as S100B and BDNF will serve as objective measures (biomarkers) of pain.

Fibromyalgia patients will be recruited into two groups-- one that uses opioids and the other that does not. Blood will be collected every 6 months for two years. The serum will be used to assay for levels of S100B and BDNF, The pressure-pain threshold (PPT) data, as part of standard of care, will also be collected. Correlation will the be assessed.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with Fibromyalgia

Exclusion Criteria:

* Evidence of a history of substance abuse, neurological or oncologic disease, ischemic heart disease, kidney or hepatic insufficiency.
Sleep Disordered Breathing (SDB) Prevalence and Cardiovascular Outcomes of Myocardial Infarction (MI) Survivors

The AMISLEEP study is nested in the "FRENCHIE" registry.

The objective is to use routine clinical and polygraphic data to capture SDB/SAS (Sleep Disordered Breathing/Sleep Apnea Syndrome) physiological heterogeneity in relation to clinically relevant cardiovascular outcomes.

Specifically, the investigators hypothesize that unique clusters (phenotypes) of patients could be identified by applying unsupervised learning methods to these data and that the clusters would be differentially associated with risk of adverse cardiovascular outcomes (ACS), TIA, stroke or death). The ultimate goal is to identify patients more at risk that could be included in interventional studies that would test whether SDB/SAS treatment can improve this risk.

All patients included in the "FRENCHIE" registry (Acute Myocardial Infarction (AMI) patients hospitalized within 48h from symptom onset) are eligible, and will be asked for their written informed consent for this nested study in case of the absence of any non-inclusion criteria.

Baseline clinical examination and laboratory tests are based on the usual care and are those collected in "FRENCHIE".

A simplified polygraphy is performed during the hospitalization for AMI. Starting and ending of the recording will be programmed based on patient interview regarding usual sleep hours.

Together with the polygraphy, questionnaires will be given to the patient regarding general sleep quality

Polygraphic data will be scored in centralized manner. Results of the polygraphy will be sent to the cardiology department with advice for treatment and follow-up. If necessary, the core-lab will provide tele-counseling regarding SDB management to centers.

Follow-up will be performed through the national administrative databases, as in the "FRENCHIE" registry.

Eligibility Criteria:
Inclusion Criteria:

* Patient included in FRENCHIE registry (cf. NCT04050956 for FRENCHIE registry's selection criteria)
* Signed consent for AMI-Sleep study

Exclusion Criteria:

* Patient under treatment for SDB/SAS prior to its inclusion in FRENCHIE registry
* Cognitive disorientation and communicative disabilities (left to investigator's discretion) not able to fill-out a questionnaire
* Severe diseases with anticipated mortality less than 6 months
A Pilot Study of the Neural Correlates of Treatment Effect on Nicotine Craving

The purpose of this study is to gather pilot data to determine feasibility of and guide the development of a larger clinical trial investigating the effects of topiramate as an adjunct to nicotine replacement therapy and behavioral counseling in smoking cessation treatment. It is hypothesized that topiramate will decrease nicotine craving and result in improved outcomes for smoking cessation.


Eligibility Criteria:
Inclusion Criteria:

* Male, between ages of 18-55
* Meets DSM-IV criteria for nicotine dependence
* Smoke at least 20 cigarettes per day
* Motivated to quit smoking

Exclusion Criteria:

* Serious or unstable medical conditions
* Current psychiatric disorder requiring medication or treatment
* Taking medication that create risk of interaction with study drug
* Current participation in another smoking cessation treatment
Effect of Multimodal Monitoring Cluster Management on Patients with Severe Traumatic Brain Injury

Traumatic brain injury (TBI) is a serious global health problem, with about 27 million new cases each year. Severe head trauma can lead to intracranial hypertension and a range of complications such as cerebral edema and hypoxia of brain tissue. Intracranial pressure monitoring is key to modern TBI treatment, but this approach does not fully reflect all relevant pathophysiological changes. Multimodal monitoring allows for a more comprehensive assessment of the severity of TBI and guidance for individualized treatment to improve patient outcomes by integrating different monitoring methods. Although more research is needed to confirm its efficacy, multimodal monitoring has been recognized as an important clinical decision support tool in neuroscience intensive care. Future studies may further optimize this approach to monitoring and provide a more effective treatment strategy for patients with TBI.


Eligibility Criteria:
Inclusion Criteria:

1.Age \>18 years, 2.Diagnosis of an acute brain injury (ABI) due to TBI, 3.GCS with Eyes response = 1 (no eyes opening) and Motor score ≤5 (not following commands) at the admission to intensive care unit (ICU) or neuro-worsen-ing within the first 48 hours with no eye opening and the Motor score decreased to ≤5.

-

Exclusion Criteria:

1. Have had a major stroke before.
2. Pregnant or likely to become pregnant. 3 In the opinion of the treatment team, the decrease in GCS (Glasgow Coma Scale) score is solely due to intoxication, sedation, or extracranial injury.

4 Participants are unlikely to comply with all study procedures, including follow-up, in the opinion of the investigator.

5. Have an underlying medical condition with a life expectancy of less than 6 months.

6. There are pre-existing contraindications to MRI examination. 7 suffer devastating TBI, either progressing to brain death at the time of recruitment, or the treating medical team does not commit to continuous, comprehensive aggressive treatment.
Ischia Spinous Fascia Fixation Surgery for Pelvic Organ Prolapse

Pelvic organ prolapse is a common problem. The primary treatment is surgery. Ischia spinous fascia fixation procedure is developed in China for vaginal apex fixation with native tissue.

This study is designed to determine the effectiveness and safety of ischia spinous fascia fixation procedure for the treatment of pelvic organ prolapse stage III.

Patients enrolled into the study will be followed up for up to 3 years after surgery. Evaluation will take place during surgery and postoperative visit. Stage of prolapse before and after surgery, patient satisfaction through quality of life and sexual function questionnaires before and after surgery, and peri-operative complication rates will be evaluated.

Pelvic Organ prolapse (a feeling of bulge in the vagina) may cause some distressing symptoms such as loss of control of the bowel or bladder, and may also cause problems with patient's sex life. An ideal procedure for vaginal apical support should provide a durable suspension, have minimal complications, and not affect sexual or visceral function.

Ischia spinous fascia fixation procedure is developed in China. It is a transvaginal procedure used for restoring the vaginal apex support with native tissue. Clinical practice showed that it was safe, efficient and cost-effective. Recurrent rate after 1 year follow-up was about 10%, and quality of life improved significantly from the baseline.

The purpose of this multicenter, prospective study is to evaluate the effectiveness and safety of this procedure in the treatment of symptomatic pelvic organ prolapse.

Eligibility Criteria:
Inclusion Criteria:

* Candidates with symptomatic pelvic organ prolapse of POP-Q Stage II or more, suitable for surgical repair.
* Vaginal hysterectomy and anti-incontinence procedures could be performed concurrently.
* Agrees to participate in the study, including completion of all study-related procedures, evaluations and questionnaires.

Exclusion Criteria:

* Previous repair of pelvic organ prolapse involving insertion of mesh.
* Experimental drug or experimental medical device within 3 months prior to the planned procedure.
* Active genital, urinary or systemic infection at the time of the surgical procedure. Surgery may be delayed in such subjects until the infection is cleared.
* Coagulation disorder or on therapeutic anticoagulant therapy at the time of surgery.
* History of chemotherapy or pelvic radiation therapy.
* Systemic disease known to affect bladder or bowel function (e.g. Parkinson's disease, multiple sclerosis, spinal cord injury or trauma).
* Current evaluation or treatment for chronic pelvic pain (e.g. interstitial cystitis, endometriosis, coccydynia, vulvodynia).
* Nursing or pregnant or intends future pregnancy.
* Chronic cough not well-controlled.
* BMI \&#8805; 30.
* In the investigator's opinion, any medical condition or psychiatric illness that could potentially be life threatening or affect their ability to complete the study visits according to this protocol.
Effect of Ultimaster Stents Treated to the Most Dilated Coronary Vessels

In patients with vasospasm or with negative remodeling, various vasodilator drugs used during coronary angiography can dilate the diameter of the reference vessel to measure the exact vessel size. In particular, nitrates are well known to induce pharmacological vasodilatory effects through vascular smooth muscle relaxation In actual clinical practice, it has been reported that when oral or spray-type nitrate preparations are administered to coronary artery stenosis lesions, the diameter of the reference vessel expands by about 10% compared to the existing vessel diameter. This may enable larger stenting in coronary artery stenosis lesions. Although many patients with vascular stenosis are accompanied by vasospasm and voice remodeling, in actual clinical practice, administration of vasodilators is only used in a small number of patients at the discretion of the surgeon. Nitrate vasodilators administered during coronary angiography are low-dose and short-acting drugs, and although a small number of patients may experience side effects such as short-term lowering of blood pressure, no serious side effects are reported .

On this background, this study is to evaluate whether there is a difference in the diameter of the Ultimaster® stent treated with the conventional method compared to the maximally dilated coronary artery, and to evaluate the stability and effectiveness after the procedure.


Eligibility Criteria:
Inclusion Criteria:

* Over 19 years old
* evidence of coronary artery disease including asymptomatic ischemia stable angina acute coronary syndrome (unstable angina, non-ST segment elevation

  * myocardial infarction, ST segment elevation myocardial infarction).
* coronary artery diameter 2.25\~3.5mm, stenosis 50% or more
* Those who voluntarily agreed in writing to participate in this clinical study

Exclusion Criteria:

* instability or psychogenic shock within 24 hours before percutaneous coronary intervention
* life expectancy no longer than 1 year
* hypersensitivity or contraindications to the following drugs or substances: heparin, aspirin, clopidogrel
* patients whom researchers think unsuitable for participation in this study
Self and Autobiographical Memory in Dementia With Lewy Bodies and Alzheimer Disease: a Behavioral and Multimodal Neuroimaging Study

The present project aims at exploring different components of Self-consciousness or 'the Self', such as autobiographical memory, self-concept and subjective sense of Self, in dementia with Lewy Bodies (DLB) compared to Alzheimer's disease and to normal ageing. Anatomical substrates will be studied in multimodal imaging, in terms of volume, anatomical and functional connectivity. We expect to find an alteration of the different components of the Self, consecutive to insular dysfunction, a key region within cerebral networks of self-consciousness, which is damaged early in the course of the disease.


Eligibility Criteria:
Inclusion Criteria:

Inclusion criteria for all participants:

* Male or female aged between 60 to 80, at the inclusion visit
* Right-handed
* Must be affiliated to a social health insurance protection scheme
* Must be able both to understand the objectives and risks related to the study and to give a dated and signed informed consent
* Fluency in French
* At least 9 years of formal education

Inclusion criteria for group of dementia with Lewy bodies:

* Subject meeting McKeith et al. criteria (2017)
* Subject with prodromal dementia with Lewy bodies meeting the DSM-V Mild Cognitive Impairment criteria (2013)
* Subject with prodromal or mild dementia with Lewy bodies with an ≤ 20 MMSE score
* Availability of a caregiver for the inclusion visit

Inclusion criteria for group of Alzheimer disease:

* Subject meeting Dubois et al. criteria (2014)
* Subject with prodromal or mild Alzheimer disease with an ≤ 20 MMSE score
* Availability of a caregiver for the inclusion visit

Inclusion criteria for healthy elderly:

* Subject must be matched with patients in terms of age, gender and educational level
* Absence of any cognitive complaint
* Autonomy must be preserved

Exclusion Criteria:

Subjects with significant neuropsychiatric comorbidities

* Abnormal neurological examination
* Sensory impairment that may significantly interfere with testing
* Contraindication to MRI
* Claustrophobia
* Heavy psychotropic drug treatment
* Excessive and regular consumption of alcohol
* Subject in period of exclusion (determined by a previous or ongoing study)
* Inability to give the subject informed information
* Subject under judicial protection
* Subject under tutorship or guardianship
Total Worker Health for Wildland Firefighters

The overarching goal is to develop, refine and disseminate a comprehensive, easily accessible and effective Total Worker Health (TWH) program for wildland firefighters (WFF).

The term Total Worker Health® (TWH) (NIOSH) refers to the synergistic combination of 1) health promotion (e.g., healthy nutrition, exercise, restorative sleep), 2) worker safety issues, such as protective equipment and hazard control, merged with 3) work organization change to support and promote TWH.


Eligibility Criteria:
Inclusion Criteria:

* any firefighter attending an OHSU-led informational meeting

Exclusion Criteria:

* Firefighters planning to retire from fire fighting work within 12 months will be excluded.
An Immunogenicity and Safety Study of Gardasil® in Chinese Subjects (V501-030)(COMPLETED)

This is a China registration study. A randomized, double-blind, placebo-controlled immunogenicity and safety study in Chinese female participants aged 9 to 45 years and male participants aged 9 to 15 years. Approximately 600 participants will be randomized in a 1:1 ratio to receive either vaccine or aluminum-containing placebo. Each participant received one injection at each visit at Day 1, Month 2, and Month 6. Vaccine or placebo was given as a 0.5-mL intramuscular injection. Serum will be collected from all participants to evaluate immune response against anti-Human Papillomavirus (HPV) 6/11/16/18 with Luminex Assay. At Month 2, Month 6, Month 7, subjects will be evaluated for any new medical condition or health concerns and Serious Adverse Experiences throughout the study. The primary objective is to evaluate the vaccine-induced serum anti-HPV 6, 11, 16 and 18 antibody titers following 3-dose regimen of Gardasil® compared with placebo.


Eligibility Criteria:
Inclusion Criteria:

* Healthy female participants aged 9-45 years old and male participants aged 9-15 years old
* Participants agrees to provide study personnel with a primary telephone number as well as an alternate telephone number for follow-up purposes
* Not pregnant now (as demonstrated by a negative urine beta-Human Chorionic Gonadotropin (beta-HCG) test) for post-pubertal female participants
Neuroimaging Correlates of Memory Decline Following Carotid Interventions

Carotid revascularization can significantly reduce the risk of stroke in patients with severe carotid stenosis; however, it has been associated with cognitive decline in 25% of the older adults who undergo the procedure. Characterizing risk factors for cognitive decline following carotid interventions and individualizing treatment strategy based on those risks can minimize procedure-associated cognitive dysfunction. Neuroimaging techniques that characterize white matter integrity and regional hypoperfusion have the potential to provide sensitive brain structure indicators that may be associated with memory decline following revascularization procedures. In this protocol, we hope to determine how cerebral blood flow and baseline white matter abnormality in the vulnerable region modify the frequency and cognitive effect of microembolization following carotid revascularization procedures.


Eligibility Criteria:
Inclusion Criteria:

* Patient is male or female \>40 yrs of age.
* Patient has occlusive extracranial carotid stenosis (≥70%)
* Patient is scheduled to undergo a carotid revascularization procedure
* Patient agrees to voluntarily participate in the study and signs an informed consent.
* Patient agrees to be available for follow-up and is able to participate in all study testing procedures.
* Patient has sufficient visual and auditory acuity for cognitive testing.

Exclusion Criteria:

* Patient is unable to safely and comfortably undergo MR imaging procedures (e.g., claustrophobia, implanted medical devices that are MRI incompatible such as pacemaker, defibrillator, neural stimulator etc)
* Patient has an untreated or unsuccessfully controlled psychiatric disease (schizophrenia, bipolar disorder).
* Patient has prominent suicidal or homicidal ideation.
* Patient has acute illness or unstable chronic illness (e.g. uncontrolled hypertension, hepatic encephalopathy, portal hypertension, ascites, and esophageal varices, pancreatitis).
* Patient with a history of neurological (e.g., multiple sclerosis, seizure disorder, Parkinson's disease) or systemic illness affecting central nervous system function.
* Patient has prior closed head injury with ≥24 hours of amnesia.
The Effects of Exogenous Ketones on Glucose Tolerance

The ketone body beta-hydroxybutyrate is produced during prolonged fasting or when endogenous carbohydrate stores are depleted and can be used as an alternative fuel source. Exogenous beta-hydroxybutyrate, in the form of a ketone monoester, is proposed to have glucose-lowering potential but this has not been adequately studied. The purpose of this study is to determine whether supplementing with an acute dose of ketone monoester can improve the glycemic response to a high carbohydrate mixed meal in young healthy individuals.


Eligibility Criteria:
Inclusion Criteria:

* Young healthy individuals
* Not taking any medications affecting glucose metabolism

Exclusion Criteria:

* Competitive endurance athlete (i.e., train specifically for cycling, triathlon or distance running and compete at a high level)
* Diagnosed with the chronic medical condition that may impact consumption of carbohydrates or supplements (e.g., diabetes, heart disease)
* Are currently using medications that may interfere with insulin sensitivity
* Adhere to a strict high-fat low-carbohydrate or ketogenic diet (within the last 3 months)
* Are currently using ketone supplements
* Unable to travel to and from the university in order to make your testing appointments.
* Unable to follow the controlled diet instructions required for the study.
* If pregnant or are planning to become pregnant during the study (if female)