cyrilzakka/clinical-trials huggingface dataset:
A New Way of Cardiac Denervation to Reduce the Incidence of AF After CABG.

This is a prospective, random controlled trial(RCT) study. 430 patients undergoing coronary artery bypass grafting were enrolled. Our new way of cardiac denervation, defined as excision of Marshall ligament and Waterstone fat pad, was performed in 215 patients, and the other 215 patients were used as control subjects. All the patients need to equip with electronic monitor to record heart rhythms within 6 days after CABG. The investigators will compare the incidence of postoperative atrial fibrillation between two groups, and follow up 30 days after discharged.


Eligibility Criteria:
Inclusion Criteria:

1. Patients undergoing simple CABG (on-pump/off-pump) for the first time.
2. Patients who signed the informed consent form and willing to undergo cardiac denervation.

Exclusion Criteria:

1. Age \< 18；
2. Emergent CABG;
3. Cardiac surgery history；
4. Receiving other cardiac surgery except of CABG at the same time, such as Morrow、valvular surgery、ventricular aneurysm surgery、congenital heart diseases surgery；
5. Requiring mechanical or pharmacological therapy for hemodynamic support before CABG, such as ECMO or IABP;
6. History of AF ;
7. Taking antiarrhythmic agents except of beta-blockers last 2 weeks.
A Study Exploring the Use of Challenge Agents in Healthy Volunteers or Participants With a Disease of Interest

The purpose of this study is to characterize the biological response in vivo to challenge agents (vaccines, antigen, drug, or mechanical challenges); to assess the safety and tolerability of the challenge agent and to characterize the immune response in skin elicited in vivo in healthy volunteers using an ultraviolet B (UVB) challenge.


Eligibility Criteria:
Inclusion Criteria:

* A woman of childbearing potential must have a negative highly sensitive serum (beta-human chorionic gonadotropin \[beta-HCG\]) at screening and a negative urine pregnancy test prior to study intervention administration on Day -4
* Must have Fitzpatrick skin type II or III (10 participants) or type IV or higher (2 participants)
* Otherwise healthy on the basis of physical examination, medical history, and vital signs, and, if required by the applicable Intervention Specific Appendix (ISA), a 12-lead Electrocardiography (ECG) performed at screening. Any abnormalities must be considered not clinically significant or consistent with the underlying illness in the study population and this determination must be recorded
* Otherwise healthy on the basis of clinical laboratory tests performed at screening. If the results of the serum chemistry panel, hematology, or urinalysis are outside the normal reference ranges, the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant or to be appropriate and reasonable for the population under study. This determination must be recorded in the participant's source documents and initialed by the investigator
* Must be a non-smoker (not smoked for at least 6 months prior to screening) and has not used nicotine-containing products (example, nicotine patch) for 3 months prior to screening

Exclusion Criteria:

* Has a history of dysplastic melanocytic nevi or skin cancer
* Known hypersensitivity, intolerance to UV/sunlight exposure, or any condition associated with photosensitivity
* Has Fitzpatrick skin type I, as determined by the investigator. A person with Fitzpatrick skin type I typically has unexposed skin that is bright white with frequent freckling, has blue/green eyes, and is of Northern European/British descent. They typically burn, peel, and don't tan in response to ultraviolet B (UVB)
* Has a history of chronic skin conditions, such as vitiligo, psoriasis, rosacea, severe eczema, or atopic dermatitis, and/or severe acne that would complicate or preclude evaluation of the minimal erythema dose (MED) testing and UVB challenge sites
* Has used topical antibiotics or topical corticosteroids within 1 month prior to study intervention administration and/or has a history of extensive and prolonged use (greater than \[\>\] 3 months) of topical antibiotics or topical corticosteroids
Comparision Among Classifications for Acute Diverticulitis: a Multicenter Study

Even though Hinchey classification requires operative intervention, yet remains the established and most universally used scoring system for acute diverticulitis. Several other classifications have been described. The American Association for the Surgery of Trauma (AAST) developed a severity scale for surgical conditions, including diverticulitis. The same was done by the World Society of Emergency Surgery, that proposed a specific classification mainly based on the CT scan findings. This is a pilot study to compare the AAST and WSES classifications for acute colonic diverticulitis with the traditional Hinchey classification. We hypothesize that all the classifications are equivalent one each other in predicting outcomes


Eligibility Criteria:
Inclusion Criteria:

* acute colonic diverticulitis

Exclusion Criteria:

* Other severe conditions of end-life
Feasibility Study of Genomic Profiling Methods and Timing in Tumor Samples

This is a feasibility study to look for genetic alterations in tissue and blood samples that may be useful in determining what treatments may be useful in the patient's cancer care.

As part of the study, patients will have archival tumor tissue collected, and have tumor biopsies and blood samples taken. The samples will be tested for genetic alterations, and the results will be discussed with the patient including potential treatments. If patients agree, after they have received treatment for their cancer and their disease progresses, a second biopsy procedure will be done.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years.
* Histological or cytological proof of either metastatic breast, colorectal, gynecological or melanoma malignancy.
* At least one biopsiable lesion deemed medically accessible and safe to biopsy.
* Candidate for one or more phase I or II clinical trials at the time of study enrollment or at a later time point.
* Fulfills local institution's laboratory parameters for tumor biopsy.
* Willingness and ability of patient to provide signed voluntary informed consent.

Exclusion Criteria:

* Any condition that could interfere with a patient's ability to provide informed consent such as dementia or severe cognitive impairment.
* Any contraindication to undergoing a biopsy procedure.
A Two-week Open-label Pharmacodynamic and Pharmacokinetic Study of Multiple Doses of a Darifenacin Liquid Oral Suspension in Children (2 - 15 Years) With Neurogenic Detrusor Overactivity

This study will evaluate the pharmacodynamics and pharmacokinetics of darifenacin liquid oral suspension in children, ages 2-15 years, with neurogenic detrusor overactivity. The results will support a benefit-risk based dosage recommendation for phase IIIa clinical trials.


Eligibility Criteria:
Inclusion Criteria:

* Male and female participants ages 2-15 years
* Documented detrusor overactivity associated with a known neurological condition such as meningomyelocele or spinal cord injury, and confirmed by urodynamics at baseline
* Using clean intermittent catheterization (CIC) on a regular basis
* Participating in a bowel program on a regular basis
* Able to swallow the study medication in accordance to the protocol
* Participants and/or parent/guardian able to complete the bladder diary and follow the study procedures

Exclusion Criteria:

* Treatment with drugs known to significantly affect the urinary bladder and urinary bladder outlet function
* Fecal impaction. Participants may be included, once this condition has resolved
* Clinically significant anatomical abnormalities or acquired disorders of the urinary tract
* Previous reconstructive surgery (augmentation etc.) of the bladder or bladder outlet
* Symptomatic urinary tract infection unresolved at time of urodynamic study and/or completion of bladder diary.
* Diabetes insipidus
* Electro stimulation therapy or bladder training within 2 weeks prior to Visit 1 and at any time during the study
* Concomitant diseases, in which the use of darifenacin is contraindicated
* History of hypersensitivity to darifenacin or to drugs with similar chemical structures
* Participants with any physical and cognitive impairment or any other condition which in the opinion of the investigator makes the participants unsuitable for inclusion
* Female adolescent of child-bearing potential, unless using an acceptable method of contraception
* Pregnant or nursing (lactating) female adolescents Other protocol-defined inclusion/exclusion criteria may apply.
Vytorin As Strategy To Reduce Dislipidemia In Adults (0653A-148)

This study is intended to allow physicians to check the superior clinical efficacy of Vytorin compared to atorvastatin, as the most adequate therapy using the ATP-III goals achievement and cardiovascular risk reduction in adult patients with dislipidemia.


Eligibility Criteria:
Inclusion Criteria:

* Patients Who Voluntary Accept To Participate In The Study After Been Informed By The Doctor And Signed The Informed Consent Form.

Exclusion Criteria:

* Any Another Kind Of Contraindication For Use Of Statins
* Hypersensitivity To Any Of The Active Ingredients
* Increased Serum Hepatic Enzymes (Over 3 Times Only)
* Patients With Severe Hepatic Insufficiency
* Women who are Pregnant or Potentially Pregnant
Lung Cancer ID (Identity) Study

The distribution of demographic, clinical, radiological, pathological and molecular characteristics of lung cancer at the time of diagnosis, as well as preferential association between elements of those domains, have not been specifically studied in Italy. The aim of the present project is to assess, in a systematic fashion, the demographic, clinical, radiological, pathological and molecular characteristics of advanced lung cancer at the time of diagnosis in a large Italian cohort of consecutive patients referred to two tertiary referral centers.


Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years
* Suspicion of lung cancer based on imaging (CT and/or PET/CT)
* Indication to a biopsy for diagnosis, staging and/or molecular profiling

Exclusion Criteria:

* Inability or unwillingness to provide a written informed consent
* ECOG performance status (\>3) which makes a tissue diagnosis unfeasible
* ASA 4 status
* TNM Stage I-III
Previously Implanted Pudendal Nerve Stimulation

This study seeks to examine the response of the bladder to different pudendal nerve stimulation frequencies, by studying patients who have been previously-implanted with pudendal nerve neurostimulators.

The pudendal nerve goes to the urethra, anus, and other areas of the pelvic floor. Electrical stimulation of this nerve can help with bladder, bowel, and sexual problems, and pelvic pain. Researchers do not fully understand how the nerve helps with these functions or how the anatomy is different between people. Successful stimulation of the pudendal nerve may help improve medical care for future patients with bladder problems, pelvic pain, bowel problems, and/or sexual problems.

Eligibility Criteria:
Inclusion Criteria:

* Previously received an implanted neurostimulator at the pudendal nerve
* Adult (18 or older), capable of providing own informed consent and communicating clearly with the research team
* Capable of speaking, reading, and understanding English, as all study questionnaires are standardized assessments only available in English.
* Capable of attending the experimental session

Exclusion Criteria:

* Pregnant or planning to become pregnant during study. If a woman of child- bearing potential wishes to participate in this study, they will be pre-screened with a test to detect pregnancy
* Currently has a urinary tract infection (UTI)
* Currently has or tested positive in the last 14 days for COVID-19, or is symptomatic for COVID-19
* Unwilling to allow de-identified data to be stored for future use or shared with other researchers
Prevalence of Pulmonary Embolism in ICU

The primary objective of this study was to estimate the prevalence of PE among consecutive ICU patients receiving MV who required thoracic computed tomography (CT) with contrast agent injection, regardless of whether PE was suspected clinically. The secondary objectives were to assess the association between PE and DVT, to identify risk factors for VTE, and to determine the outcome of VTE.

Background: Pulmonary embolism (PE) produces nonspecific or minimal symptoms in mechanically ventilated (MV) patients, leading to underdiagnosis. We estimated the prevalence of PE and associations with deep vein thrombosis (DVT) among MV patients.

Methods: Consecutive MV patients who required thoracic computed tomography (CT) in a single ICU. Compression ultrasound of the four limbs was performed within 48 hours of inclusion. Curative anticoagulation therapy was given immediately after PE diagnosis.

Eligibility Criteria:
Inclusion Criteria:

* all patients requiring invasive MV and thoracic contrast-enhanced CT for any reason

Exclusion Criteria:

* a diagnosis of PE before ICU admission,
* allergy to contrast agents,
* and age younger than 18 years.
Smartphone Twelve-Lead ECG Utility In ST-Elevation Myocardial Infarction II

AliveCor (www.alivecor.com) has developed several electrocardiogram (ECG) devices that interface with iOS and Android smartphones and tablets via various Kardia apps. The current Kardia family of devices can measure single lead and six limb-lead ECGs, depending on the device. KardiaMobile, KardiaMobile 6L, and KardiaMobile Card have FDA clearance for ECG rhythm recording. A modified single-lead Kardia smartphone 12-lead ECG was previously validated in the multicenter ST LEUIS study for the diagnosis of ST-Segment Elevation Myocardial Infarction (STEMI) and Non-ST-Elevation Myocardial Infarction (NSTEMI).

Recently, AliveCor developed a new device: AliveCor (AC) 12-lead (12L) ECG System to record simultaneously 4 leads of ECG and then generate complete 12-lead ECGs. A previous protocol at the University of Oklahoma involved 200 subjects with early prototypes of the AC 12L device with the specific aim to validate that it accurately generated 12-lead ECGs as compared to simultaneously acquired FDA-cleared 12-lead ECGs. The prototype version of the AliveCor 12L ECG System simultaneously measured four channels of ECG (leads I, II, V2, V4), calculated the remaining limb leads as is standard for 12-lead ECGs (Leads III, aVR, aVL, aVF) and synthesized the remaining 4 precordial ECG leads (V1, V3, V5, V6). This protocol will serve to validate the production version of the system against standard 12-Lead ECGs for the diagnosis of STEMI and NSTEMI in patients admitted to the Emergency Department or directly to the Cardiac Cath Lab for the evaluation of chest pain. It is anticipated that the waveforms for each of the 12 leads from the AC 12L ECG System will be highly correlated with the corresponding leads from the comparator commercially available 12-lead ECG devices used at participating sites. The purpose of this study is to clinically validate that the four-channel AC 12L ECG device can enable the diagnosis of STEMI and NSTEMI in a non-inferior manner to existing 12-lead ECG devices.


Eligibility Criteria:
Inclusion Criteria:

* Male or female \> 18 years of age.
* Ability to understand and sign a written informed consent form, which must be obtained prior to initiation of any study procedures.
* Symptoms of chest pain upon presentation at the Emergency Department of the participating institution.

Exclusion Criteria:

* Inability or refusal of the patient and/or the patient's legally acceptable representative to provide written informed consent for any reason.
* Other conditions that in the opinion of the Lead Investigator may increase risk to the subject and/or compromise the quality of the clinical trial.
A Sleep Intervention to Improve Outcomes Among Women at High Risk of Breast Cancer

Participants are asked to participate in a research study of the effect of a sleep intervention on improving sleep habits and reducing their risk of breast cancer.

Participants are asked to participate in this research study because they have been identified as being at higher than average risk of developing breast cancer.

The purpose of this study is to compare women who get a sleep intervention to women who do not get a sleep intervention. This study team will compare these two groups of women to see if the sleep intervention improves their sleep and if it lowers markers of inflammation that have been associated with an increased risk of breast cancer.

Objective 1: To test the effectiveness of the GO! To Sleep program at improving the sleep duration and sleep quality in women at high risk of breast cancer.

Objective 2: To test the effectiveness of improvements in sleep quality and/or duration due to the GO! To Sleep program on biomarkers of inflammation in women at high risk of breast cancer.

Objective 3: To evaluate the effectiveness of improvements in health-related quality of life after the GO! To Sleep in women at high risk of breast cancer.

Eligibility Criteria:
Inclusion Criteria:

1. Women at high risk of breast cancer due to one or more of the following:

   * Carry deleterious mutations in the BRCA1, BRCA2, PTEN, TP53, STK11, or CDH1 genes
   * Previous diagnosis of lobular carcinoma in situ (LCIS), atypical ductal hyperplasia (ADH) or atypical lobular hyperplasia (ALH)
   * Lifetime risk of 20% or greater as calculated by the National Cancer Institute (NCI) Breast Cancer Risk Assessment Tool or the Tyrer-Cuzick IBIS Risk Assessment Tool
2. Ability to access the internet and watch videos online.
3. Valid email address.
4. Self-reported sleep duration of 6 hours per night or less

Exclusion Criteria:

1. Previous diagnosis of cancer.
2. Lack of ability to read and converse in English.
3. Lack of ability to give informed consent.
Study To Evaluate Safety And Tolerability Of Pegaptanib Sodium In Patients With Diabetic Macular Edema

This study will asses sthe safety of pegaptanib sodium in patients with diabetic macular edema. The hypothesis is that pegaptanib is safe and efficacious in patients with diabetic macular edema.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
* Subjects with documented clinical diagnosis of diabetic macular edema (DME) with proliferative or non proliferative diabetic retinopathy.
* Subjects, who according to the clinical assessment of the investigator, may benefit from anti-VEGF therapy including those subjects who were participating in the A5751013 study and who, in the investigator's opinion, may benefit from continued pegaptanib sodium therapy.

Exclusion Criteria:

* Eyes with prior scatter (panretinal) photocoagulation within 4 months prior to baseline or anticipated scatter (panretinal) photocoagulation within the next 6 months.
* Presence of any abnormality that is likely to confound assessment of visual acuity improvement in eyes in which macular edema resolves, or improves, such as non-perfusion for \>1 disc area involving the foveal avascular zone (FAZ - involving 2 or more quadrants centered around the foveal avascular zone), epiretinal membrane associated with signs of contraction and/or significant opacification (i.e. striae within 1 disc diameter of the foveal center), or presence of chorioretinal atrophy involving the center of the macula.
* Vitreomacular traction determined clinically and/or by optical coherence tomography (OCT), which, in the investigator's opinion, contributes to the macular edema (or causes associated foveal detachment), and would preclude improvement with pegaptanib sodium.
* Any other cause of macular edema such as vitreous extension, or entrapment to anterior segment wound, or any retinal vein occlusion involving the macula.
Monitoring and Predicting Breast Cancer Neoadjuvant Chemotherapy Response Using Diffuse Optical Spectroscopic Imaging

The investigators have developed imaging protocols to monitor and predict breast cancer response to neoadjuvant chemotherapy, both prior to and as early as possible during the course of treatment.

The efficacy and practicality of conventional imaging approaches in the neoadjuvant chemotherapy setting varies and identifies the need for alternate functional imaging strategies. Diffuse optical spectroscopic imaging is an experimental imaging method that allows patients to be followed from baseline through treatment and surgery with a cost-effective, bedside, handheld scanning probe. The researcher evaluates a harmonized diffuse optical spectroscopic imaging technology platform that has been standardized for neoadjuvant chemotherapy monitoring. Diffuse optical spectroscopic imaging is an academic research platform that is non-invasive. Studies will be performed in five clinical sites on approximately 60 neoadjuvant chemotherapy patients.

The investigators are testing the effectiveness of an experimental imaging technology known as Diffuse Optical Spectroscopy Imaging in predicting the success of chemotherapy treatment (shrinkage of tumor).

Diffuse optical spectroscopic imaging measurements are made with a laser breast scanner. This bedside-capable system combines frequency-domain photon migration with steady-state tissue spectroscopy to measure complete(broadband) near-infrared absorption and reduced scattering spectra of breast tissue in vivo. Diffuse Optical Spectroscopy Imaging measurements are made by placing the hand-held probe on the tissue surface and moving the probe to discrete locations along a grid pattern at 1.0 cm intervals. The portable high-bandwidth Frequency-Domain Photon Migration instrument employs intensity-modulated diode lasers and conventional steady-state lamps as sources and an avalanche photodiode as the detector. The time required to perform an Frequency-Domain Photon Migration measurement depends on the desired precision and number of sweeps.

Eligibility Criteria:
Inclusion Criteria:

* Female, 18 years of age or older, non pregnant or nursing.
* Diagnosis of breast cancer and will be receiving chemo therapy treatments

Exclusion Criteria:

* 18 years of age or younger, pregnant or nursing.
* Previous treatment including chemo therapy, radiation, surgery, and hormone therapy.
* Previous diagnosis with other form of cancer.
tACS for Sensory Motor Recovery After Stroke

The overall goal is to investigate the effectiveness of a novel intervention - transcranial alternating current stimulation (tACS) for motor recovery in stroke survivors.


Eligibility Criteria:
Inclusion/exclusion criteria for stroke subjects

Inclusion criteria:

1. Age between 18\~75 years old
2. ≥ 6 months post stroke, medically stable;
3. Unilateral, single stroke (no restriction on type (ischemic or hemorrhagic) or volume (large or small) of stroke);
4. Visible finger flexor activation/movement
5. The ability to give consent

Exclusion criteria:

1. Patients with visual deficit/neglect; hearing or cognitive impairment;
2. Patients that are currently adjusting tone alternating medications (e.g., baclofen), or
3. Patients received botulinum toxin injection to the arm/fingers \<4 months, or phenol injections \<2 years;
4. Patients with pacemaker, metal implants or supplemental oxygen;
5. Patients who have musculoskeletal disorders, including pain in the affected side
6. Women who are pregnant.