cyrilzakka/clinical-trials huggingface dataset:
Fibroid Ablation Study - Large Fibroids

The purpose of this study is to establish the effectiveness and confirm the safety of the VizAblate System in the ablation of large (\> 5 cm) symptomatic uterine fibroids.


Eligibility Criteria:
Inclusion Criteria:

* 28 years of age or older
* Consistent menstrual cycles
* History of excessive bleeding for at least 3 months
* Baseline UFS-QOL Symptom severity score ≥ 20
* At least one target fibroid having a maximum diameter \> 5cm and ≤ 10 cm
* Not at material risk for pregnancy
* Willingness to participate, adhere to follow-up requirements, and sign the informed consent form
* Willing to have uniform maintenance of antifibrinolytic or non steroidal anti-inflammatory agents
* Menstrual Pictogram score ≥ 120 during a one-month screening period.

Exclusion Criteria:

* Presence of type 0 intracavitary fibroids
* Target fibroid \> 10cm in maximum diameter
* Abnormality of the endometrial cavity that obstructs access of the treatment device
* Postmenopausal
* Desire for current or future fertility
* Hemoglobin \< 6 g/dl
* Evidence of disorders of hemostasis
* Use of GnRH agonist or depomedroxyprogesterone acetate or other implantable or injectable progestin and/or estrogen, SERM or SPRM within the last 6 months prior to screening
* Evidence for current cervical dysplasia (CIN II or greater)
* Endometrial hyperplasia
* Confirmed abdominal / pelvic malignancy within previous five years
* Active pelvic infection or positive screen for pelvic gonorrhea or chlamydia
* Clinically significant adenomyosis
* Previous uterine artery embolization
* Previous surgical or ablative treatment for fibroids or menorrhagia within 12 months prior to screening
* Current use of anticoagulant therapy
* Major medical or psychiatric illness affecting general health or ability to adhere to follow-up
* Contraindication to MRI
* Renal insufficiency
* Uncontrolled hypertension lasting 2 years or more
* Calcified fibroids
* Presence of extrauterine pelvic mass
* Presence of tubal implant for sterilization
* Previous pelvic irradiation
* Endometrial cavity length \< 4.5 cm
Direct or Subacute Coronary Angiography in Out-of-hospital Cardiac Arrest

The overall aim of this prospective, randomized study is to investigate whether acute coronary angiography (within 120 minutes) with a predefined strategy for revascularization, will improve 30-day survival in patients with out of hospital cardiac arrest with no signs of ST-elevation on ECG after Restoration of Spontaneous Circulation (ROSC). The patients will be randomized to a strategy of immediate coronary angiography within 120 minutes or to a strategy of delayed angiography that may be performed three days after the cardiac arrest.

The study is a prospective randomized open label multicenter study with a registry follow up in which patients with out of hospital cardiac arrest without ST-elevation on their first ECG will be randomized to either a strategy of immediate coronary angiography (treatment group) with possible coronary intervention or a strategy of delayed coronary angiography (control group). The study will include in total 1006 patients with Restoration of Spontaneous Circulation (ROSC). Randomization will be done via a web-based module after ECG is taken at the first medical contact but no later than after arrival at the emergency room. Coronary angiography should be performed within 120 minutes from randomization in the immediate angiography group. In the delayed angiography group, angiography with possible coronary intervention will be performed at the discretion of the interventional cardiologist and should preferably not be performed until three days after the cardiac arrest. This strategy is in accordance with standard practice. In case of recurrent chest pain, ST elevation, circulatory instability or cardiogenic shock, cross over to early angiography may occur. The quality of life and health economics will be evaluated at 6 months. The patients will undergo extensive neurocognitive tests and health instruments, these will be analyzed and presented.

Eligibility Criteria:
Inclusion Criteria:

* Witnessed out of hospital cardiac arrest
* Restoration of Spontaneous Circulation (ROSC) \>20 minutes
* Coronary angiography is expected to be performed within 120 minutes from inclusion and randomization at hospital

Exclusion Criteria:

* Patient age \<18 years
* Obvious extracardiac genesis of cardiac arrest such as trauma, hemorrhagic shock, and / or asphyxia (eg drowning, suffocation, hanging, exposure to fire smoke)
* Terminally ill patients with a life expectancy of less than 1 year
* Patients with ST-elevation
* Known pregnancy
* Patient awake GCS \>8 (Glasgow Coma Scale)
Diagnosis and Treatment of Sleep Apnea in the Acute Exacerbation of Heart Failure

Congestive heart failure affects 2.3 percent of the population (approximately 4,900,000) with an incidence of 10 per 1,000 of the population after the age of 65 (1). The admission rate for patients with heart failure is on the rise, so is the mortality associated with it and its national annual bill, now exceeding $21 billion (1). Obstructive Sleep Apnea (OSA) is present in 11-37 percent of patients with heart failure (2,3), and tends to increase in severity when the heart failure is less controlled (4, 5). Therefore, the actual prevalence of OSA in patients hospitalized with acute heart failure is likely higher. There is now evidence that treatment of OSA with nasal Continuous Positive Pressure (nCPAP) in outpatients with stable heart failure improves left ventricular ejection fraction, and quality of life (6), and confers a reduction in fatal and non-fatal cardiovascular events (7). However, there has not been any evaluation of the role of diagnosis and treatment of OSA in patients hospitalized with acute heart failure. This uncertainty about the true prevalence and role of OSA in exacerbations of heart failure, and the role of its treatment in the acute setting may explain why aggressive diagnostic and therapeutic strategy for OSA in patients admitted to the hospital with acute heart failure is not part of the standard clinical practice in acute care centers. Given the rising admission rate, and mortality associated with heart failure, an evaluation of the role of OSA and its treatment in this patient population is highly significant.

OSA is associated with large negative swings in the intrathoracic pressure, significant increase in the sympathetic nerve activity and repetitive surges in blood pressure, along with episodic hypoxia and hypercapnea (8, 9). These autonomic and respiratory changes may increase the cardiac muscle workload, cardiac dysrrhythmia, and exacerbate ischemia (10,11,12). Treatment with continuous positive airway pressure (CPAP) is the most successful therapeutic modality available for obstructive sleep apnea. It is still not clear whether establishing the diagnosis of OSA and initiating treatment with CPAP while still in the hospital carries any benefit in the management of patients with acute heart failure. This study will evaluate the effect of work up and treatment of OSA on the outcome of patients hospitalized with acute congestive heart failure (CHF).

Eligibility Criteria:
.Inclusion Criteria:

* Able to provide an informed consent
* Speaks English
* Older than 21
* Heart Failure
* Positive for OSA

Exclusion Criteria:

* CSA
* Already on CPAP
* Hemodynamic instability
* Acute respiratory failure
* Neurological defect
* Dialysis
Atrial Fibrillation Patients Treated With Catheter Ablation

This is a single-center prospective observational cohort study of atrial fibrillation patients treated with radiofrequency ablation.

The effect of radiofrequency therapy on the life quality and atrial function of atrial fibrillation patients will be assessed, through the multidimensional analysis of baseline clinical data, serological indicators of atrial fibrosis, echocardiography, cardiac magnetic resonance imaging, atrial potential mapping, life quality, and long-term ECG monitoring within 1 week after radiofrequency ablation. A predictive model for atrial fibrillation recurrence after ablation will be established. Based on the cross-sectional analysis of baseline data, the relationship between non-invasive assessment of atrial fibrosis (imaging and serology), atrial electrical activity, and atrial function will be analyzed as well, and atrial fibrillation patients with ventricular fibrosis will be selected for gene sequencing to explore the existence of underlying cardiomyopathy and provide data for further research.

Eligibility Criteria:
Inclusion Criteria:

* Non-valvular atrial fibrillation, including paroxysmal atrial fibrillation and persistent atrial fibrillation
* 18-80 years old
* The anteroposterior diameter of the left atrium is less than 50mm via TTE
* Patient meets the intervention criteria for bilateral pulmonary vein isolation after evaluation by electrophysiological specialists
* Patient consents to ablation treatment

Exclusion Criteria:

* Intra-atrial thrombus detected by TEE
* Hyperthyroidism
* Previous radiofrequency ablation for atrial fibrillation
A Correlative Study for Predicting Response and Toxicity in Patients Receiving Chemotherapy for Breast Cancer

The proposed trial provides a unique opportunity in that it combines genomic, proteomic, and pharmacogenomic assessments in patients receiving the most commonly used chemotherapies for advanced breast cancer. To date no other trial has analyzed gene and protein expression at the same time points in the same patient, combined with clinical outcome. Similar to previous attempts to predict response based on expression of a single gene or protein, the researchers expect that neither genomic or proteomic profiling alone will be sufficient to optimize therapy. Rather, the researchers expect an iterative process that combines information gleaned from both platforms, modified to avoid toxicity based on pharmacogenomics.

OUTLINE: This is a 4 arm, multi-center study.

Sample Collection:

* Core Biopsy
* Serum
* Urine

Treatment Regimens (Investigator/Patient Discretion):

* Arm A: Doxorubicin 60 mg/m2 + Cyclophosphamide 600 mg/m2 day 1 of every 21-day cycle
* Arm B: Capecitabine 1000 mg/m2 BID days 1-14 of every 21-day cycle
* Arm C: Vinorelbine 25 mg/m2 days 1, 8, 15 of every 28-day cycle
* Arm D: Gemcitabine 1000 mg/m2 days 1, 8, 15 of every 28-day cycle

Performance status \& Organ Function:

Performance status and organ function appropriate for chemotherapy in the opinion of the treating investigator according to Good Clinical Practice (GCP).

Life Expectancy: Not specified

Hematopoietic: Not specified

Hepatic: Not specified

Renal: Not specified

Cardiovascular: Not specified

Pulmonary: Not specified

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed adenocarcinoma of the breast with locally advanced or metastatic disease.
* Disease amenable to pre-treatment core or incisional biopsy with adequate tissue for histology and genomic/proteomic analysis.
* Measurable disease as assessed within 21 days prior to being registered for protocol therapy by RECIST.
* Planned chemotherapy with one of the following regimens:

  1. Doxorubicin 60 mg/m2 + Cyclophosphamide 600 mg/m2 day 1 of every 21-day cycle
  2. Capecitabine 1000 mg/m2 BID days 1-14 of every 21-day cycle
  3. Vinorelbine 25 mg/m2 days 1, 8, 15 of every 28-day cycle
  4. Gemcitabine 1000 mg/m2 days 1, 8, 15 of every 28-day cycle

Exclusion Criteria:

* No serious uncontrolled medical or surgical condition that the investigator feels might compromise study participation.
* Negative pregnancy test obtained within 7 days prior to being registered for protocol therapy for women of child bearing potential.
* Unwillingness to use adequate contraception (or practicing complete abstinence). Subjects should be advised that adequate contraception (or complete abstinence) must be continued while on treatment and for a period of 3 months after the final dose of chemotherapy.
* No breast-feeding.
Drug Interaction Study Between Bosutinib And Dabigatran

The study evaluates the effect of a single oral dose of bosutinib on the single dose pharmacokinetics of dabigatran, a p-glycoprotein substrate, in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects between 21 to 55 years old and BMI between 17.5 and 30.5 kg/m2.

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
* Risks of bleeding including prior personal or familiar history of abnormal bleeding, hereditary or acquired coagulation or platelet disorder or abnormal coagulation test (PT/INR or PTT/aPTT greater than upper limit of normal) result at screening.
* Pregnant or nursing females; females of childbearing potential who are unwilling or unable to use an acceptable method of non-hormonal contraception as outlined in this protocol from at least 14 days prior to the first dose of study medication.
Evaluation of 18F-DCFBC PSMA-based PET Imaging for Detection of Metastatic Prostate Cancer

This research is being done to see if an investigational radioactive drug called 18F-DCFBC can help us find cancer that has spread (metastatic disease) from its original site in people who have cancer in their prostate to other parts of their body.

The objective of this study is to evaluate a radiolabeled urea-based small molecule inhibitor of prostate-specific membrane antigen (PSMA), \[18F\]DCFBC (DCFBC) PET imaging for detection of metastatic prostate cancer. PSMA is a well characterized histological marker of prostate cancer tumor aggressiveness and metastatic potential. The investigators propose to assess the ability of DCFBC PET to detect metastatic prostate cancer by visual qualitative and quantitative SUV analysis. Correlation will be made to sites of suspected metastatic disease detected by standard conventional imaging modalities (CIM) for prostate cancer which includes IV contrast CT of chest/abdomen/pelvis and whole body bone scintigraphy.

Eligibility Criteria:
Inclusion Criteria:

1. Histological confirmation of prostate cancer
2. Radiologic evidence of new or progressive metastatic disease demonstrated on anatomical imaging (CT, MRI, or ultrasound), bone scintigraphy, \[18F\]Sodium Fluoride PET, and/or \[18F\]FDG PET
3. Rising PSA on two observations taken at least 1 week apart
4. Adequate peripheral venous access or available central venous catheter access for radiopharmaceutical administration
5. Patient can remain on androgen deprivation therapy if on the same regimen prior to documentation of progressive metastatic disease
6. Patient cannot start a new therapy for prostate cancer prior to study radiopharmaceutical imaging
7. Patient is judged by the Investigator to have the initiative and means to be compliant with the protocol and be within geographical proximity to make the required study visits
8. Patients or their legal representatives must have the ability to read, understand and provide written informed consent for the initiation of any study related procedures

Exclusion Criteria:

1. Patient has been treated with an investigational drug, investigational biologic, or investigational therapeutic device within 14 days prior to study radiotracer administration
2. Prior radiation therapy, chemotherapy, or androgen-deprivation therapy within 2 weeks prior to study radiotracer administration (Washout is one half-life of the drug or 2 weeks, whichever is longest)
3. Initiation of new therapy for progressive metastatic disease since radiographic documentation of progression.
4. Serum creatinine \> 3 times the upper limit of normal
5. Total bilirubin \> 3 times the upper limit of normal
6. Liver Transaminases \> 5times the upper limit of normal
7. Unable to lie flat during or tolerate PET/CT
8. Prior history of any other malignancy within the last 2 years, other than skin basal cell or cutaneous superficial squamous cell carcinoma that has not metastasized and superficial bladder cancer.
Comparison of Single İncision Laparoscopic Cholecystectomy Versus Laparoscopic Cholecystectomy

The aim of this study is to compare outcomes of quality-of-life measures and evaluate the body image and cosmesis between Single Incision Laparoscopic Cholecystectomy (SILC) and Conventional Laparoscopic Cholecystectomy (CLC).Twenty eight patients underwent SILC and 30 underwent LC.Fifty-eight patients were included the study and divided into two groups. The results of the questionnaires were statistically compared.

Recently, single incision laparoscopic cholecystectomy (SILC) is one of the minimally invasive technique, developed to reduce the need of multiple ports and has become popular among the surgeons. This study was conducted with fifty eight patients between January 2011 and March 2013 in Turkey. Fifty-eight patients were included the study and divided into two groups. Quality-of-life measures was evaluated by the EuroQol EQ-5D questionnaire.Cosmesis and body image were evaluated with the Body Image Questionnaire. All statistical analyses were performed by IBM Statistics 21.0 and MS-Excel 2007. A value of p\<0.05 was accepted as statistically significant.

Eligibility Criteria:
Inclusion Criteria:

* The patients who were scheduled for elective cholecystectomy were included in the study

Exclusion Criteria:

* pregnancy
* acute cholecystitis
* ASA 3-4 (American Society of Anesthesiologists)
* history of bile duct stone migration
* biller pancreatitis
* upper laparatomy
* any ventral hernia repair
* chronic systemic disease or
* with allergic attitude to any agent
Feasibility Study of the Head and Neck Survivorship Tool: Assessment and Recommendations (HN-STAR)

This study is being done to understand how survivors of head and neck cancer think they can make HN-STAR (the Survivor Self-Assessment, the survivorship clinic experience, and the Survivorship Care Plan the best it can be. Once the investigators have your input and input from other survivors, they can make changes to HN-STAR, so that they can test this tool in a larger study. The larger study will tell them whether using HN-STAR improves the care of head and neck cancer survivors.


Eligibility Criteria:
Inclusion Criteria:

Aim 1: Part 1

* Have completed treatment for head and neck cancer at least 1 year prior to survivorship visit and have no evidence of disease
* Have a primary care provider
* Be able to provide informed consent
* Be able to speak and read English
* Be at least 18 years old

Aim 1: Part 2

* Have completed treatment for head and neck cancer at least 1 year prior to survivorship visit and have no evidence of disease
* Have a primary care provider
* Be able to provide informed consent
* Be able to speak and read English
* Be at least 18 years old

Exclusion Criteria:

Aim 1: Parts 1 and 2 is the same

* Patients or providers who cannot speak or read English
* Patients with cognitive, visual, or motor impairment such that they cannot complete the Survivor Self-Assessment as assessed by the research team.
Interleukin-1 Receptor Antagonist Gene Polymorphism and Adverse Pregnancy Outcome in Turkish Women

The investigators hypothesized that the IL-1A (+4895), IL-1B (+3954), and IL-1RN gene polymorphisms may be associated with PLBW. Smoking has been well documented by numerous studies as a major environmental risk factor for periodontitis and adverse pregnancy outcomes. Therefore, the investigators only selected non-smoking individuals in this study as the smoking-related risk could obscure the polymorphism-related increase in risk for periodontitis and adverse pregnancy outcomes. This study aimed to determine the association between IL-1A (+4895), IL-1B (+3954), and IL-1RN polymorphisms with adverse pregnancy outcomes and periodontitis in a non-smoking Turkish population.

Pregnant women between 18-35 years of age with single gestation and with ≥20 on-crowded teeth excluding third molars were included in this study. Subjects were divided into normal birth (NB) and PLBW groups on the basis of their pregnancy outcome. Women who delivered an infant with a birth weight of more than 2500 g after 37 weeks of gestation were placed in the NB group. Women who delivered infants whose birth weight was below 2500 g or before 37 weeks of gestation were placed in the PLBW group. Current/past tobacco user, alcohol abuse, history of high-risk gestation, hypertension, gestational diabetes, any systemic disease and placenta previa were the exclusion criteria for this study. Maternal, obstetric, and demographic factors such as maternal age, maternal education, regular prenatal care, genitourinary tract infections during pregnancy, total number of births, previous PLBW, and antibiotic use during the pregnancy period were also recorded.

Eligibility Criteria:
Inclusion Criteria:

Subjects were divided into normal birth (NB) and PLBW groups on the basis of their pregnancy outcome. Women who delivered an infant with a birth weight of more than 2500 g after 37 weeks of gestation were placed in the NB group.

Exclusion Criteria:

Current/past tobacco user, alcohol abuse, history of high-risk gestation, hypertension, gestational diabetes, any systemic disease and placenta previa were the exclusion criteria for this study.
Study to Assess Effectiveness of Therapy Timely Adjustment Based on Self-monitoring in Patients Suffering From Mild-to-moderate Ulcerative Colitis (OPTIMISE Study)

The purpose of this study is to provide evidence that a therapy of Ulcerative Colitis (UC) disease adjusted on tight monitoring of non-invasive parameters, such as clinical symptoms and faecal calprotectin (FC) (substance that is released when intestines are inflamed and that can be measured in faeces), can provide significantly higher benefit for the participants in terms of disease control and quality of life (QoL) improvement, compared to a symptom-based approach only.


Eligibility Criteria:
Inclusion Criteria:

* Adult Participants (≥ 18 years old)
* Participants with active mild-to-moderate UC (with RB and bowel inflammation confirmed by endoscopy)
* Participants with treatment with 5-aminosalicylic acid (5-ASA) ≤ 2.4 g/day or with no treatment regimen at Baseline
* Participants who agree to use FC home test (to dose FC in faeces as a marker of inflammation)
* Participants with internet access and smartphone with camera

Exclusion Criteria:

* Participants currently enrolled in another interventional study
* Participants not willing to undergo an endoscopy at the end of study
* Participants with contraindications to treatment with 5-ASA and/or 2nd generation corticosteroids
* Participants not willing to perform FC self-testing in faeces at home