cyrilzakka/clinical-trials huggingface dataset:
Correlation of the Arrhythmia Mechanism and Substrate to Ablate Persistent Atrial Fibrillation Study

This is a pilot study to assess the usefulness of ECG mapping, and enhanced MRI and PET scan imaging in identifying atrial fibrosis and arrhythmia circuits involved in persistent atrial fibrillation and in guiding an innovative AF catheter ablation strategy.

It is hypothesized that identifying these critical arrhythmia circuits and atrial fibrosis with enhanced imaging and performing an individualized innovative AF catheter ablation will result in higher procedural success rates.

Pulmonary vein isolation catheter ablation for the treatment of persistent AF (PeAF)or longstanding persistent AF is associated with success rates of 40-50% at one year. Experimental models have shown that AF results in progressive structural changes due to electrical atrial remodeling, where AF burden correlates with atrial fibrosis. The optimal ablation strategy for patients with PeAF is not yet known. There is limited understanding of the critical mechanisms responsible for maintenance of AF in these patients.

In this study ECG body mapping (ECGI) will be used to look for distinct electrical rotors in the atria. Delayed gadolinium enhanced magnetic resonance imaging (DE-MRI) will be used to assess the extent of left atrial fibrosis. In addition to PVI catheter ablation procedure, an ablation strategy guided by the results of the ECGI mapping and DE-MRI will be performed.A C-metahydroxyepherdrine (HED) PET scan will also be done pre-ablation to evaluate left atrial sympathetic denervation and any relationship to the initiation and/or maintenance of AF.

Subjects will be seen at 3 and 6 months after ablation, with 12 lead ECG and 2-week loop monitoring done at each visit.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years and ≤ 80 years;
* Symptomatic persistent AF AND clinically indicated for AF catheter ablation
* At least one episode of AF lasting more than 7 days, documented on 12-lead ECG, Holter monitor, 2-week loop monitor or trans-telephonic monitor (TTM) within 12 months of enrollment in the study
* Able to provide informed consent.

Exclusion Criteria:

* History of previous catheter or surgical ablation for AF
* Presence of intracardiac thrombus
* contraindication to systemic oral anticoagulation therapy
* Subjects with reversible causes of AF
* Antero-posterior left atrial dimension \> 60 mm on echocardiography
* Severe valvular disease (mitral/aortic stenosis or regurgitation);
* Subjects that are pregnant or breastfeeding;
* Chronic kidney disease and creatinine clearance \<50ml/min.
* Contraindication to MRI Imaging (e.g. permanent pacemaker, metallic implants, etc)
New Approach of Assessing Drug Response for Treatment of Nasopharyngeal Cancer

The combination of pEBV DNA (half-life) and PET-CT following 1 course of chemotherapy allow earlier and more detection of drug response in advanced NPC than RECIST method, in patients with previously untreated advanced NPC who will receive platinum-based chemotherapy. This study will also determine if this new method can predict survival in these patients. This study may have far-reaching impact on drug development in NPC as it may offer a more optimal way of evaluating drug efficacy in clinical trials and also in clinical management.


Eligibility Criteria:
Inclusion Criteria:

* undergo chemotherapy for any one of the following settings:

  1. Setting 1: Neoadjuvant chemotherapy prior to cheom-RT
  2. Setting 2: Palliative chemotherapy in Chemonaive patients
  3. Setting 3: Palliative chemotherapy in previously treated patients (i.e. 2nd line or 3rd line chemo)
* Age \>= 18 years
* (ECOG) performance status of 0-2
* have detectable levels of pEBV DNA at baseline
* have measurable tumor sites by RECIST criteria
* have adequate bone marrow, renal and hepatic functions
Methylene Blue Chromoendoscopy in Barrett's Esophagus

This study is being done to:

Determine if a temporary dye applied to the esophagus identifies areas of dysplasia (pre-cancer). Determine if certain dye patterns indicate specific grades of dysplasia. Determine if overall endoscopy costs can be reduced with this dye technique. Determine if the dye could allow fewer biopsies to be obtained in the future.

Although methylene blue has been used effectively to identify areas of SIM in several studies, its superiority in identifying dysplasia in the setting of Barrett's esophagus has been inconclusive. In all studies to date dysplastic yield was equivalent or better than protocol techniques while requiring fewer biopsies. Variations in study design, staining technique and inexperience in staining interpretation are some of the reasons. Our goal is to build on the techniques that have been shown to be effective, standardize them for the purposes of our study, and to objectively evaluate if MB directed biopsies are useful in screening Barrett's patients for dysplasia. At the time of EGD when length of Barrett's is determined, patients will be stratified into either intermediate (2-4cm) or long segment (\>4cm) Barrett's. Short segment Barrett's esophagus patients will not be considered, as MB techniques have not proved beneficial in dysplasia detection as previously described 7.

Eligibility Criteria:
Inclusion Criteria:

* History of Barrett's with or without dysplasia
* Able to give consent

Exclusion Criteria:

* Pregnancy or women of child-bearing potential
* Active esophagitis
* Esophageal varices
* Esophageal cancer (history of or current)
* Hypersensitivity to methylene blue
* Severe renal impairment (creatinine\>2.0)
* Known glucose-6-phosphate dehydrogenase (G-6-PD) deficiency
* Symptomatic coronary artery disease
* Coagulopathy (INR\>/=1.5)
* Thrombocytopenia \</= 20K/ul
* Previous esophageal ablative therapy (EMR,PDT, APC)
Single Rising Dose Study of BI 655088 Administered Intravenously in Healthy Male Volunteers

Investigation of safety and tolerability of BI 655088 following intravenous infusion of single rising doses and exploration of the pharmacokinetics and pharmacodynamics of BI 655088 after single dosing


Eligibility Criteria:
Inclusion criteria:

* Healthy male subjects
* Age of 18 to 50 years
* Body mass index (BMI) of 18.5 to 29.9 kg/m2
* Additional inclusion criteria may apply

Exclusion criteria:

* Any finding in the medical examination (including BP, PR or ECG) deviating from normal and judged as clinically relevant by the investigator
* Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg or diastolic blood pressure outside the range of 50 to 90 mmHg or pulse rate outside the range of 45 to 90 bpm
* Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
* Any evidence of a concomitant disease judged as clinically relevant by the investigator
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Diseases of the central nervous system (including but not limited to any kind of seizures and stroke), and other relevant neurological disorders or psychiatric disorders
* Additional exclusion criteria may apply
Trial Comparing Near Versus Distance Activities While Patching for Amblyopia in Children 3 to <7 Years Old

Ths purpose of this study is to determine whether "near" activities enhance the effect of patching on visual acuity improvement in strabismic and anisometropic amblyopia when compared with "distance" activities in the treatment of moderate amblyopia and severe amblyopia in children 3 to \<7 years old.

The value of "near visual activities" while patching for amblyopia is controversial. Some pediatric eye care providers currently recommend that the child perform near visual tasks while wearing a patch over the sound eye, while other pediatric eye care providers do not prescribe any specific visual tasks to be performed while the patch is worn.

In previous randomized studies of patching doses for amblyopia conducted by the Pediatric Eye Disease Investigator Group, near visual activities were incorporated into the prescribed treatment regimes. Although different doses of patching, combined with near visual activities, were successful in improving visual acuity in most children, it is unclear whether concurrent near visual activities enhanced the effect of patching.

This study is designed as an efficacy study, making effort to maximize adherence to treatment group assignments.

The study has been designed as a simple trial that, other than the type of amblyopia therapy being determined through the randomization process, approximates standard clinical practice. The two treatment regimens for the 17 week treatment period are: 1) 2 hours of daily patching combined with near visual activities while patching and 2)2 hours of daily patching combined with distance visual activities while patching.

Eligibility Criteria:
Inclusion Criteria:

* Patients must be 3 to less than 7 years old with amblyopia due to strabismus, anisometropia, or both.
* Visual acuity in the amblyopic eye must be between 20/40 and 20/400 inclusive, visual acuity in the sound eye 20/40 or better and inter-eye acuity difference \> 3 logMAR lines.
* Spectacles, if needed, must be worn for at least 16 weeks or until visual acuity documented to be stable.

Exclusion Criteria:

* Prior amblyopia treatment other than spectacles in the past month.
* More than one month of amblyopia treatment in the past 6 months.
Improving Beliefs About Medication in Patients With Rheumatoid Arthritis

The purpose of this study is to determine if a short motivational patient-centered intervention for non-adherent patients is more successful in improving beliefs about medication (and adherence) compared to a usual care control group of non-adherent patients.

Disease Modifying Anti Rheumatic Drugs (DMARDs) reduce disease activity and radiological progression and improve long term functional outcome in patients with Rheumatoid Arthritis (RA). However, adherence is a prerequisite for a drug to be effective. A previous study showed that 33% of the RA-patients using DMARDs are non-adherent. Non-adherence can not be attributed to a single cause, but is the result of a complex and individual decision process. An intervention should not only consider practical barriers, such as forgetfulness, but also cognitive and other psychological variables that might impact medication adherence. Therefore, an intervention was developed focusing primarily on the non-adherent patient's individual beliefs and barriers to adherence.

The effectiveness of this intervention will be evaluated in a randomized clinical trial. Primary outcome measure is beliefs about medication assessed with the Beliefs about Medicines Questionnaire (BMQ). Additionally, adherence and adherence-related variables will be measured with questionnaires.

Eligibility Criteria:
Inclusion Criteria:

* RA according to the 1986 ACR criteria for at least 1 year
* Prescription of anti-rheumatic medication (DMARDs)
* Non-adherent patients (Compliance Questionnaire Rheumatology)

Exclusion Criteria:

* Co-morbidity (physical or psychological) that unables patient to participate in the intervention
* Illiteracy
* Inability to communicate in Dutch
* Participation in other studies with significant burden
ARTEMIS: Study of Patients With Early Stage Pancreatic Cancer Who Have Undergone Genetic Testing

This study includes participants with pancreatic cancer who are undergoing genetic testing at Invitae related to their diagnosis of pancreatic cancer.

Our goal in this study is two-fold. First, we would like to research whether any inherited changes in genes may be associated with pancreatic cancer. Second, we would like to learn more about patient experiences with genetic testing, such as patient understanding of the testing, health-related actions taken (or planned to take) as a result of testing, communication and action of family members based on test results, and psychological impact of testing.

This research study involves allowing collection of tumor tissue (from a prior biopsy and/or surgery), a blood sample, and sending surveys to participants for their opinion on the impact of the genetic testing as well as clinicians for relevant baseline and medical history information.

Patients will be contacted for patient outcomes survey completion at months: 1, 4, 8, 12, 18, 24, 30, 36, 42, 48, 54, and 60. Patients will also be contacted for survival collection every 6 months during years 3-5 post germline testing.

Clinicians will be contacted for relevant medical history, treatment, and survival data at the same time points.

At baseline, 3 samples types will be collected: 1. EDTA tube for germline genetic testing. 2. Streck tubes for whole genome sequencing and other analyses. 3. Tumor block from surgical resection. If block is unavailable 10 unstained slides are an acceptable substitute.

Eligibility Criteria:
Inclusion Criteria:

* Patient has consented to germline genetic testing
* Patient has a histologically confirmed diagnosis of pancreatic cancer
* Patient has undergone or is planned to undergo surgical resection with curative intent
* Patient is willing to allow collection of a tissue sample from surgical resection
* Patient is willing to provide research blood samples (every 6 months for 2 years)
* Patient must be at least 18 years of age

Exclusion Criteria:

* Patient has evidence of metastatic or recurrent pancreatic cancer at time of consent
* Patient is unable to consent.
Safety and Efficacy Study of Herpes Simplex Virus Type 2 (HSV-2) Therapeutic DNA Vaccine

The purpose of this trial is to evaluate the safety and efficacy of a therapeutic DNA vaccine in adults with symptomatic herpes simplex virus type 2 (i.e., genital herpes).

To evaluate the safety and efficacy of 4 doses of VCL-HB01, a therapeutic HSV plasmid DNA vaccine formulated with Vaxfectin® in HSV-2-seropositive adults with a reported history of symptomatic genital herpes for at least one year.

Eligibility Criteria:
Inclusion Criteria:

* HSV-2 seropositive
* A minimum of 1 year of reported history of genital herpes with recurrences.

Exclusion Criteria:

* History of receiving an investigational HSV vaccine
* Chronic illness for which a subject's immune system is suspected to be impaired or altered, such as cancer, autoimmune conditions, or diabetes
* Pregnant or breastfeeding
Genetic Analysis of Human Hypertensive End Stage Renal Disease (H-ESRD)

To identify genes causing hypertensive end-stage renal disease (H-ESRD) in high risk African-American populations

BACKGROUND:

Although hypertension is a predisposing factor for end stage renal disease, the underlying hypothesis of this study was that in select African-American families genetic factors predisposed them to develop ESRD in the face of hypertension. An inherited basis for H-ESRD was supported by familial clustering of H-ESRD among African Americans that could not be explained by socioeconomic status, access to medical care, and the prevalence of diabetes and hypertension.

DESIGN NARRATIVE:

DNA samples were collected, identified, and clinically characterized from African-American sib-pairs (and other family members with hypertensive end-stage renal disease). This aspect of the study was based on the fact that Dr. Freedman, the principal investigator, had already developed a unique "family history of end-stage renal disease" database independently funded by the End-Stage Renal Disease Network Six. This registry served as a very large and unique collection of African-American end-stage renal disease patients. He began with a candidate gene approach for linkage to hypertensive end-stage renal disease in his patient samples using a variety of growth factor genes, genes involved in sodium transport and vascular tone, as well as human homologues of rodent genes that had, or were to be identified in the future as contributing to ESRD in that organism. If this initial first pass of candidate genes failed to demonstrate linkage to hypertensive end-stage renal disease, a systematic genome-wide scan was to be performed with available simple sequence length polymorphisms (SSLP) and other polymorphic markers. Hypertensive end-stage renal disease is a condition of enormous clinical and economic importance and identification of associated or causative renal-failure genes would form a genetic basis for the detection of high-risk individuals and assist in development of intervention and treatment strategies to prevent this condition.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria
A Study to Assess the Safety and Efficacy of ZPL389 With TCS/TCI in Atopic Dermatitis Patients

This extension study (CZPL389A2203E1) was designed as a 2-year (100 weeks) extension to the core study (CZPL389A2203/ NCT03517566) which is disclosed separately. It aimed to assess the short-term and long-term safety of (blinded) 30 mg o.d and 50 mg o.d ZPL389 with concomitant or intermittent use of topical corticosteroids (TCS) and/or topical calcineurin inhibitors (TCI).

Subjects who had received ZPL389 30 mg or 50 mg doses in the core study (CZPL389A2203), continued to receive the same doses in double-blinded fashion. Subjects who had received ZPL389 3 mg, 10 mg or placebo in the core study were randomized to 30 mg or 50 mg ZPL389 in a 1:1 ratio. All subjects received concomitant or intermittent TCS and/or TCI along with ZPL389. Short-term safety was assessed up to week 16 of this extension study (week 16 to week 32 referring to the start of core study treatment) and long-term safety was assessed after week 16 of this extension study (after week 32 referring to the start of core study treatment). The entire planned time frame (100 weeks) was not assessed as originally planned due to early termination of the core and extension studies.

Eligibility Criteria:
Inclusion Criteria:

* Subjects must give a written, signed and dated informed consent
* Subjects with atopic dermatitis who have participated in and completed 16 weeks of treatment in CZPL389A2203 study.
* Willing and able to comply with scheduled visits, treatment plan, laboratory tests, diary completion and other study procedures.

Exclusion Criteria:

* Inability to use TCS and/or TCI due to history of important side effects of topical medication (e.g., intolerance or hypersensitivity reactions).
* Treatment discontinued subject from CZPL389A2203 study.
* Any skin disease that would confound the diagnosis or evaluation of atopic dermatitis disease activity.
Rejection Sensitivity and Puberty in Mental Health Vulnerability to Social Media Experiences in Early Adolescent Girls

This longitudinal study is designed to test bidirectional relationships between preteen girls' mental health and social media experiences. We will explore how pubertal development and experiences of rejection influence these relationships.


Eligibility Criteria:
Inclusion Criteria:

* female aged 10-11 years
* engagement in social media use
* proficient in the English language
* family/personal device that can complete daily diaries

Exclusion Criteria:

* previously diagnosed chronic medical illness
* autism spectrum disorder
* significant developmental or speech delay
* endocrine disorder
* not assigned female at birth (AFAB)
The Use of Drospirenone/Estetrol, Nomegestrol Acetate/Estradiol and Ethinylestradiol/Dienogest in Random Start Rapid Endometrial Preparation

The presence of a thin endometrium plays an important role in enabling the best conditions for hysteroscopic surgery. Recently, for this purpose, many studies have evaluated the effect of preoperative administration of a variety of drugs. We explored the efficacy of random started 14-day administration of Drospirenone/Estetrol or Nomegestrol Acetate/Estradiol or Ethinylestradiol/Dienogest, in rapid preparation of endometrium for hysteroscopic polypectomy.


Eligibility Criteria:
Inclusion Criteria:

* Patients with endometrial polyps.

Exclusion Criteria:

* Patients with other endometrial pathologies.
Aspirin Dose and Atherosclerosis in Patients With Heart Disease

The purpose of the study is to test higher versus lower doses of aspirin on markers of atherosclerosis in patients who have had a heart attack.

Aspirin reduces risks of heart attacks, strokes, and deaths from cardiovascular causes in patients who have survived a prior event as well as during an acute heart attack.

Low dose aspirin is sufficient to achieve complete inhibition of platelet aggregability, or stickiness, and this is the mechanism whereby aspirin prevents formation of blood clots.

Our research is designed to explore whether higher doses of aspirin provide additional benefits on markers of atherosclerosis.

Eligibility Criteria:
Inclusion Criteria:

1. Age 40 to 80 years, inclusive.
2. Patients with stable coronary disease, with and without diabetes mellitus, defined by:

   1. angiographic evidence of 70% or greater stenosis, or
   2. previous percutaneous coronary intervention (PCI), or
   3. coronary artery bypass graft (CABG), or
   4. history of a MI, or
   5. positive exercise test

Exclusion Criteria:

1. Patients taking greater than 81mg aspirin daily.
2. Patients taking any of the following medications for less than 3 months, or who plan to take them for the first time during the next 3 months: ACE-inhibitors, angiotensin receptor blockers, calcium channel blockers, or statins.
3. Patients within 6 months of a coronary intervention, including PCI or CABG.
4. Patients with a planned coronary intervention.
5. Patients taking anti-platelet drugs such as clopidogrel or non-steroidal anti-inflammatory drugs (NSAIDs) or anticoagulant drugs such as warfarin.
6. Patients who are currently cigarette smokers.
7. Women patients who are pregnant, planning to become pregnant, nursing a child, or taking hormone replacement therapy.
8. Patients with any coagulation, bleeding or blood disorders.
9. Patients who are sensitive or allergic to aspirin.
10. Patients with documented history of any gastrointestinal disorders, including bleeding ulcers.
11. Patients with any evidence of cancer or kidney, liver, lung, blood, or brain disorders.
12. Patients with asthma, rhinitis, or nasal polyps.
13. Patients with any abnormal laboratory value or physical finding that, in the view of the responsible clinician, may interfere with interpretation of the trial results, be indicative of an underlying disease state, or compromise the safety.
14. Patients with Class IV heart failure.
15. Patients with severe aortic insufficiency, or aortic regurgitation.
16. Patients with hearing loss or tinnitus.
17. Patients with tremors which cause them not to be able to remain motionless for approximately 30 seconds.