cyrilzakka/clinical-trials huggingface dataset:
Multi-electrode PulmonarY Vein Isolation Versus Single Tip Wide Area Catheter Ablation for Paroxysmal Atrial Fibrillation (PAF)

The MYSTIC_PAF trial investigates the differences between treatment with a single-tip catheter against a multielectrode catheter in cardiac ablation procedures in patients with paroxysmal atrial fibrillation.


Eligibility Criteria:
Inclusion Criteria:

1. History of symptomatic paroxysmal atrial fibrillation defined as:

   * Self-terminating AF with episodes lasting no more than seven consecutive days before spontaneous conversion back to sinus rhythm
   * Documentation of one or more events with PAF tracings by ECG, event recordings, pacemaker strips or monitor rhythm strips within the past year
   * AF symptoms defined as the manifestation of any of the following:

     * Palpitations
     * Fatigue
     * Exertional dyspnea
     * Effort intolerance
2. Age between 18 and 70
3. Willingness, ability and commitment to participate in baseline and follow-up evaluations for the full length of the study

Exclusion Criteria:

1. Structural heart disease of clinical significance including:

   * Previous cardiac surgery (excluding CABG)
   * Symptoms of congestive heart failure including, but not limited to, NYHA Class III or IV CHF and/or documented ejection fraction \< 40% measured by acceptable cardiac testing
   * Left atrial diameter of \> 50mm as measured in the parasternal long axis on transthoracic echocardiogram
   * Stable/unstable angina or ongoing myocardial ischemia
   * Myocardial infarction (MI) within three months of enrollment
   * Aortic or mitral valve disease \> Grade II
   * Congenital heart disease (not including ASD or PFO without a right to left shunt) where the underlying abnormality increases the risk of an ablative procedure
   * Prior ASD or PFO closure with a device using a percutaneous approach
   * Hypertrophic cardiomyopathy (LV wall thickness \> 1.5 cm)
   * Pulmonary hypertension (mean or systolic PA pressure \>50mm Hg on Doppler echo
2. Prior ablation for arrhythmias other than AF within the past three months
3. Prior left sided AF ablation
4. Enrollment in any other ongoing arrhythmia study protocol Any ventricular tachyarrhythmias currently being treated where the arrhythmia or the management may interfere with this study
Comparing Newly Developed PreCore Needle With Conventional Fine Needle in Suspected Unresectable Pancreatic Cancer

Background:

Pancreatic cancer is associated with a poor prognosis. Therefore, rapid and accurate diagnosis of a pancreatic mass is important to direct patient management. Endoscopic ultrasonography-guided fine needle aspiration (EUS-FNA) is the current standard for sampling pancreatic mass lesions, with diagnostic accuracy of 78% to 95%. But, the EUS-FNA has some limitations include stromal cell tumors and lymphomas may be difficult to diagnose. To overcome these limitations, a new needle device with ProCore reverse-bevel technology was developed recently.

Aims:

The objective of this prospective study is to compare the rate of diagnostic sufficiency in the EUS sampling by using newly developed ProCore needle with conventional FNA needle in suspected unresectable pancreatic cancer. We will also compare the safety, the yield of histologic core tissue and the cost-effectiveness between these modalities.

Patient:

Newly diagnosed pancreatic cancer patient whose cancer lesion is suspected unresectable in diagnostic imaging such as CT or MRI

Procedure:

Each EUS-guided FNA and ProCore aspiration will performed twice in same patient. The priority of order will be given by randomization assignment.

The number of patients required:

Total sixty five patients will be required.

Eligibility Criteria:
Inclusion Criteria:

* Patients who agree to participate in research
* 18 years of age and older patients less than 80 years old
* Patients who have suspected unresectable pancreatic cancer in imaging studies

Exclusion Criteria:

* Contraindication to endoscopy
* Patients younger than 18 years old or older than 80 years old
* Bleeding tendency
* Cardiopulmonary dysfunction
* Pregnancy
Efficacy and Safety of DWP450 for the Treatment of Crows Feet Lines

The purpose of this study is to evaluate the Efficacy and Safety of DWP450 treatment of Crows Feet Lines(CFL).


Eligibility Criteria:
Inclusion Criteria:

* Male or female of at least 18 to 75 years old
* Bilaterally symmetrical moderate-to-severe CFL at maximum smile on the FWS as rated by the investigator
Omega 3 Fatty Acids on Serum Irisin and Sirtuin-1 in Type 2 Diabetic Mellitus Patients Treated With Glimepiride

study the effect of omega 3 fatty acids on blood glucose, lipids profile, serum Irisin and sirtuin-1 in type 2 diabetic mellitus patients treated with glimepiride.

1. Approval will be obtained from Research Ethics Committee of Faculty of Pharmacy, Damanhour University
2. All Participants agreed to take part in this clinical study and provide informed consent.

Methodology

* The study will be conducted in 70 patients who are aged 30-60 years old with type 2 diabetes mellitus for at least 2 years. The patients will be assigned into two groups (Omega - 3/glimepiride, n=35; glimepiride, n=35).
* Serum Irisin, sirtuin-1, Hb A1C, Fasting blood sugar (FBS), Lipid profile, Fasting insulin, HOMA-IR and Atherogenic index of plasma (AIP) will be measured at the beginning and after 12 weeks of intervention.
* Anthro-pometric parameters including Weight and height to calculate body mass index will be measured at the beginning and after intervention.
* past medical history and medication history will be documented.
* Each subject in the test group will receive a total dose of 1000 mg of omega-3 fatty acids per day in the form of three capsules along with a glimepiride tablet to be taken once daily, while each subject in the other group will receive glimepiride tablet to be taken once daily for 12 weeks.
* Venous blood samples will be obtained from patients at the beginning and after 12 weeks of intervention.
* A commercially available enzyme-linked immuno-sorbent assay kits will be used for the measurement of Irisin and sirtuin-1.
* The patients will be advised not to change their usual diet, drug regimen and physical activity levels throughout the study.

Eligibility Criteria:
Inclusion Criteria:

* 70 Adult patients aged 30-60 years old with type 2 diabetes mellitus treated with glimepiride.
* glycated hemoglobin percent greater than 7%.
* body mass index between 25 and 35 kg/m2.
* Patients who are not consuming omega-3 fatty acids, supplements or any pharmaceutical products that may interact with their lipid profile.

Exclusion Criteria:

* Pregnant or lactating women.
* Have gastrointestinal disorders that interfere with the bowel function
* patients with severe hepatic, renal, inflammatory and thyroid diseases.
* insulin therapy.
* Have diabetes complications including micro and macrovascular complications.
* Alcoholics and patients with past history of drug abuse.
Histomorphometry Analysis in Fertile and Infertile Patients

To detect similarities and differences in the endometrium of fertile and infertile patients

morphometric and pathologyc analysis of the endometrium in fertile and infertile patients

Eligibility Criteria:
Inclusion Criteria:

* 18 to 41 years old
* regular menses
* infertility over 12 months

Exclusion Criteria:

* previous uterine surgery
* use of contraceptive pills or injections less than 3 months from the inclusion in the study
Activity Limitations in Rheumatoid Arthritis

Objective: To evaluate what factors contribute to activity limitations in subjects with rheumatoid arthritis considering the International Classification of Functioning, Disability and Health model.

Methods: A cross-sectional study on 81 individuals with rheumatoid arthritis (RA) using instruments to measure five constructs of the component activities.

The investigators used the ICF model to analyze factors reported to be associated with functioning and disability in individuals with RA, including dexterity fatigue, stiffness , pinch, handgrip, strength, range of motion (ROM) deficit, deformities , mental health, vitality, and pain .

Eligibility Criteria:
Inclusion Criteria:

* Age over 18 years,
* Clinical diagnosis rheumatic arthritis
* Mental competence by the Mini-Mental State Examination

Exclusion Criteria:-

* Had undergone upper limb surgery,
* Had an uncorrected visual deficit that could compromise functionality
Total Laparoscopic Hysterectomy With Sacrocolpopexy Versus Total Laparoscopic Hysterectomy With Lateral Suspension in Patients With Pelvic Organ Prolapse

This prospective randomized surgical trial is designed to compare objective and subjective outcomes of total laparoscopic hysterectomy with sacrocolpopexy versus total laparoscopic hysterectomy with lateral suspension for the treatment of pelvic organ prolapse


Eligibility Criteria:
Inclusion Criteria:

* Women with symptomatic pelvic organ prolapse stage II or higher (according to the International Continence Society Pelvic Organ Prolapse quantification system - POPQ) in anterior and/or apical (central) compartment that require surgical management

Exclusion Criteria:

* Patients that are not candidates for general anesthesia or laparoscopy
* Inability to consent
* history of hysterectomy
* history of anterior or apical pelvic organ prolapse surgery
* history of urinary incontinence surgery
* pregnancy or breast-feeding during the study period
* suspicious adnexal masses or other factors that may indicate pelvic malignancy
Predictive Value of Whole Blood Coagulation Parameters for Post-discharge Venous Thromboembolism After Cancer Resection

This study plans to learn more about the role of 2 blood tests in predicting who might develop a blood clot in their arm or leg after major surgery. The investigators know that patients who have cancer and major surgery have a higher than normal risk of getting blood clots in the veins of their arms or legs. This can be very dangerous because the clot can move into your lungs.

Venous Thromboembolism (VTE) after cancer surgery hospitalization is the most common cause of death at 30 days after cancer surgery, and is a significant source of patient morbidity and health care cost. Pharmacoprophylaxis has proven efficacy in preventing post-discharge VTE in surgical cancer patients, but perceived risks and costs pose barriers to widespread adoption by clinicians. Risk stratification of this patient population is necessary to allow appropriate prescription of prophylaxis to the highest risk patients. Can the investigators develop a risk stratification model that includes a readily available laboratory test, the thromboelastogram with or without platelet mapping?

Eligibility Criteria:
Inclusion Criteria:

* subjects who are having primary, open resection surgery of gastrointestinal or bladder cancer

Exclusion Criteria:

* currently receiving anticoagulation therapy
* pregnant
Influence of Z Shaped and Conventional Sulcular Incisions on Healing and Interproximal Bone Loss in Implant Surgery

The present study is a human, prospective, parallel, randomised controlled clinical trial conducted to check the interproximal bone loss of Z shaped incision over conventional sulcular H shaped incision.The trial is in accordance with the Consolidated Standards of Reporting Trials (CONSORT) criteria, 2010.

Twenty healthy individuals satisfying the inclusion and exclusion criteria were recruited for the study. A detailed, thorough medical and dental history was obtained and each patient was subjected to comprehensive clinical and radiological examination. All patients were informed about the nature of the study, the surgical procedure involved, potential benefits and risks associated with the surgical procedure and written informed consent were obtained from all patients. In the test group patients Z shaped incision was done to place implants and H shaped sulcular incision was placed in control group.

The clinical and radiographic parameters were recorded at baseline,24 hours,7days, three months and six months postoperatively.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with single or multiple edentulous spaces in the maxillary and mandibular arches having Siebert's Class 1 and 2 ridge defects.
2. Patients willing to participate in the study.
3. Patients above 18 years of age.
4. Patients exhibiting keratinized tissue width more than or equal to 2 mm.
5. Systemically healthy patients.
6. Patients who demonstrate full mouth plaque control and bleeding scores\<25% and showing good compliance.

Exclusion Criteria:

1. Patients who do not give consent.
2. Untreated periodontal disease, caries.
3. Insufficient oral hygiene.
4. Smokers.
5. Previous radiation therapy.
6. Patients with known systemic diseases and conditions
7. Pregnant and lactating women.
Lay User Evaluation of the Panbio™ HCV Self-Test

This is a prospective, multi-centre study designed to evaluate the usability of the Panbio™ HCV Self Test, when performed by untrained lay users in an observed study setting. The Panbio™ HCV Self Test detects antibodies to Hepatitis C Virus (HCV). The study validation will be conducted in accordance with the World Health Organisation's technical guidance on Hepatitis C rapid diagnostic tests for professional use and/or self-testing (TSS-16).

Hepatitis C is a liver disease caused by the hepatitis C virus. The virus can cause both acute and chronic disease, ranging in severity from a mild illness lasting a few weeks to a serious, lifelong illness. Globally, Hepatitis C virus infects around 71 million people per year, resulting in 700,000 deaths. The WHO estimates that only 21% of individuals chronically infected with HCV are diagnosed, and the WHO HCV targets include increasing the diagnoses to 90% by 2030. WHO guidelines, published in 2021, strongly recommend offering self-testing for HCV as an additional approach to HCV testing services.

Eligibility Criteria:
Inclusion Criteria:

* Participant is aged 14 or over
* Participant agrees to all aspects of the study and is able and willing to provide informed consent / assent with parental consent.

Exclusion Criteria:

* Participant has already participated in this study on a previous occasion.
* Participant is aware of their HCV status
* Participant is deemed unfit for the study by the Investigator.
* Participant has a condition deemed unfit by the Investigator to safely perform or receive the test.
* Participant is a practising health-care professional or laboratory scientist / technician or has prior medical or laboratory training or experience
* Participant is currently enrolled in a study to evaluate an investigational drug or vaccine.
* Participant has a visual impairment that cannot be restored using glasses or contact lenses or is unable to read the Instructions for Use.
* Participant is unwilling or unable to provide informed consent.
* Participant has participated in the study "Lay user evaluation of the Panbio™ HCV Self Test: A prospective, multi-centre usability study to evaluate lay user labelling comprehension and test result interpretation".
Study of KITE-363 or KITE-753 in Participants With Relapsed and/or Refractory B-cell Lymphoma

The goal of this clinical study is to learn more about the safety and dosing of the study drugs, KITE-363 and KITE-753, in participants with relapsed and/or refractory B-cell lymphoma.

Eligible study participants who have received IP administration with either KITE-363 or KITE-753 will transition to a separate Long-term Follow-up study (Study KT-US-982-5968) to complete the remainder of the 15-year follow-up assessments.

Eligibility Criteria:
Key Inclusion Criteria:

* Relapsed and/or refractory B-cell lymphoma (R/R BCL).
* At least 1 measurable lesion.
* Adequate organ and bone marrow (BM) function.

Key Exclusion Criteria:

* History of malignancy other than nonmelanoma skin cancer or carcinoma in situ (eg, cervix, bladder, or breast) unless disease free and without anticancer therapy (with the exception of hormonal therapy in the case of breast cancer) for at least 3 years.
* History of Richter's transformation of chronic leukemic lymphoma, small lymphocytic lymphoma, or lymphoplasmacytic lymphoma.
* History of allogeneic stem cell transplant (allo-SCT).
* Auto-SCT within 6 weeks before the planned KITE-363 or KITE-753 infusion.
* Presence of fungal, bacterial, viral, or other infection that is uncontrolled or requires intravenous (IV) antimicrobials for management.
* Known history of human immunodeficiency virus (HIV) infection, hepatitis B virus (HBV) hepatitis B surface (HBs) antigen (HBsAg) positive infection, or hepatitis C (anti-hepatitis C virus \[HCV\] positive) infection.
* Individuals with detectable cerebrospinal fluid (CSF) malignant cells or brain metastases or a history of central nervous system (CNS) lymphoma, primary CNS lymphoma, or spinal epidural involvement.
* History or presence of a CNS disorder.
* History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, active arrhythmia, New York Heart Association Class II or greater congestive heart failure or other clinically significant cardiac disease within the 6 months before enrollment.
* Primary immunodeficiency.
* History of autoimmune disease resulting in or requiring systemic immunosuppression and/or systemic disease-modifying agents within the last 2 years.
* History of non-line associated, clinically significant deep-vein thrombosis or pulmonary embolism requiring therapeutic anticoagulation within the 6 months before enrollment.
* Females of childbearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the preparative chemotherapy on the fetus or infant. Females who have undergone surgical sterilization or have been postmenopausal for at least 2 years are not considered to be of childbearing potential.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Patient Satisfaction After Patient-specific Jawline Augmentation

The survey studies patient satisfaction after titanium patient specific jawline augmentation in congenital, post-trauma, deformity and transgender/cosmetic jaw angle/border deficiencies.

Additively manufactured titanium implants have been pre-designed in the hospital department, further designed and manufactured by 2 Belgian companies. The issue is if all patients have satisfactory perception of the improvement of their morphology and the actual outcome of the procedure, and how theur social ineractions are perceived today.

Eligibility Criteria:
Inclusion Criteria:

- All lower jaw augmentation implants

Exclusion Criteria:

- N/A
Efficacy of Interval Aerobic Training Versus Laser Puncture Therapy on Restless Leg Syndrome in Copd Patient

DETERMINE HOW TO IMPROVE THE QUALITY OF LIFE FOR PATIENTS WITH COPD BY DECREASING TINTENSITY OF THE RESTLESS SYNDROME

Patients with restless legs syndrome can benefit greatly from aerobic exercise, and a novel treatment for enhancing quality of life is laser puncture therapy.

Eligibility Criteria:
Inclusion Criteria:

* Men with COPD who were between the ages of 40 and 60 and had a BMI between 25.5 and 29.0 were eligible to enroll if they had received a diagnosis of COPD at least two years priorAn intense desire to move the legs is frequently accompanied by unpleasant and uncomfortable leg sensations. Patients usually experience worsening symptoms when they are at rest, sitting, or lying down. Walking and stretching are examples of physical activity that can help reduce these symptoms to some or all of their intensity

Exclusion Criteria:

* 1) Individuals suffering from acute infections and malignant diseases; 2) Individuals with a history of kidney disease, hiatus hernia, severe gastro-esophageal reflux, and osteoporosis 3) Patients with severe anemia and congestive heart failure 4) Individuals with severe neurological and musculoskeletal conditions.
Eeva™ Pregnancy Investigational Clinical Study: A Postmarket Follow-Up Study

The purpose of this postmarket study is to gather data to evaluate the impact of using Eeva with traditional morphology grading on clinical pregnancy rates.

The purpose of this postmarket study is to gather data to evaluate the impact of using Eeva with traditional morphology grading on clinical pregnancy rates, as compared to a matched case control group that used morphology grading only to select embryos for transfer.

Eligibility Criteria:
Inclusion Criteria:

* Women undergoing fresh in vitro fertilization treatment using their own eggs or donor eggs.
* IVF cycle attempts ≤ 3.
* Egg age ≤ 40 years.
* Planned Day 3 embryo transfer.
* At least 5 normally fertilized eggs (2PN).
* All 2PN embryos must be imaged by Eeva.
* Normal uterine cavity as evaluated by standard methods.
* Fertilization using only ejaculated sperm (fresh or frozen) - no surgically removed sperm.
* Willing to comply with study protocol and procedures.
* Willing to provide written informed consent.

Exclusion Criteria:

* Planned preimplantation genetic diagnosis.
* Planned "freeze all" cycle (oocytes or embryos).
* Concurrent participation in another clinical study.
Effect of Regulated Oxygen-Enriched Negative Pressure Therapy (RO-NPT) On Soft Tissue Wound Repair

The investigators believe that regulated oxygen-enriched negative Pressure Therapy (RO-NPT) will be beneficial in the reduction or elimination of anaerobic infection in hard-to-heal soft tissue wounds.


Eligibility Criteria:
Inclusion Criteria:

* Patients with hard-to-heal wounds

Exclusion Criteria:

* Everyone else