cyrilzakka/clinical-trials huggingface dataset:
The Effect of Virtual Reality Application on Pain Due to Fistula Puncture in Hemodialysis Patients

The aim of this study is to examine the effect of virtual reality application on fistula puncture-related pain (FPi-A) in hemodialysis patients.

Hypotheses of the Research:

H0-1: Virtual reality application has an effect on fistula puncture-related pain in HD patients.

H1-2: Virtual reality application has no effect on fistula puncture-related pain in HD patients.

In the study, virtual reality will be applied in the fistula puncture procedure in patients receiving hemodialysis treatment.

* Demographic/medical data will initially be recorded prior to fistula puncture.
* The patient will be prepared for the virtual reality application and fistula puncture and will be given a comfortable sitting position.
* Virtual reality glasses will be put on the patient 6 minutes before the fistula puncture and the application will be started.
* The patient will continue to monitor the virtual reality application during the fistula puncture procedure. It will be ensured that no communication with the patient is made until the application is finished.
* The application will be ended with the fixation of the needle on the fistula after the fistula puncture procedure.

Eligibility Criteria:
Inclusion Criteria:

* No diagnosis of neuropathic pain
* No sedatives, analgesics and sedatives are applied 3 hours before the application.
* Not taking recently taken antipsychotic drugs and tranquilizers,
* Deaf and visually impaired (to mark VAS pain)
* Without cognitive and psychiatric diagnosis
* Open to communication and cooperation
* Patients who agreed to participate in the study

Exclusion Criteria:

* Kidney transplant
* Discomfort due to virtual reality glasses
* Suspected/diagnosed COVID-19
* Patients who want to leave the study voluntarily
* Death
* Multiple fistula puncture attempts
Mindfulness Meditation Versus Physical Exercise: Comparing Effects on Stress and Immunocompetence

The objective of this research project is to examine if including mindfulness meditation or physical exercise at lunch break improve workers' recovery from work stress. Therefore, 72 workers included either mindfulness meditation or physical exercise during their lunchbreaks for a month in order to find out if these recovery strategies have more favorable outcomes than usually spent lunch breaks concerning: a) psychological detachment, b) perceived stress, c) general health, d) burnout, e) fatigue, f) quality of sleep, g) cortisol awakening response and h) immunocompetence.

The investigators conduct an intervention study in a sample of 72 knowledge-workers, who engaged in mindfulness meditation or physical activities for five weeks. They performed from 15 to 30 minutes during their lunch breaks. The investigators randomly assigned participants to three experimental conditions: 1) mindfulness meditation, 2) physical activity, 3) control group (lunch break as usual). Online questionnaires before and after intervention assessed long term changes regarding recovery processes, perceived stress, health, mindfulness and burnout. For daily changes, a mobile application was developed to assess changes once per day immediately after work. The investigators also collect saliva samples to map cortisol and immunoglobulin A excretion across the intervention period. The investigators had two follow-up measures one and six months after the intervention.

Eligibility Criteria:
Inclusion Criteria:

* Knowledge-workers of an specific company with similar stress level.

Exclusion Criteria:

* Serious illness
* Regular meditation
* Regular physical exercise
Safety and Immunogenicity of Two Doses of Monovalent Inactivated Influenza Vaccine That is Adjuvanted With MF59C.1 (MF59) and Uses a Surface Antigen From a Potential Pandemic Virus Strain Candidate (H5N1) in Adult and Elderly Subjects Using Four Different Vaccination Schedules

The present study will evaluate the immunogenicity, safety and immunogenicity of two doses of monovalent inactivated influenza vaccine that is adjuvanted with MF59C.1 (MF59) and uses a surface antigen from a potential pandemic virus strain candidate (H5N1) in Adult Subjects.


Eligibility Criteria:
Inclusion Criteria:

* Subjects aged 18 to 60 years of age who are mentally competent and who have signed an informed consent form after having received a detailed explanation of the study protocol;
* In good health as determined by:

  * Medical history,
  * Physical examination,
  * Clinical judgment of the Investigator;
* Able to understand and comply with all study procedures and to complete study diaries, can be contacted, and will be available for all study visits.

Exclusion Criteria:

* Previous receipt of any H5 vaccine;
* Receipt of another investigational agent within 4 weeks, or before completion of the safety follow-up period in another study, whichever is longer, prior to enrollment and unwilling to refuse participation in another clinical study through the end of the study;
* Experienced any acute disease or infection requiring systemic antibiotic or antiviral therapy (chronic antibiotic therapy for urinary tract prophylaxis is acceptable) within the past 7 days;
* Experienced fever (defined as axillary temperature 38.0°C) within 3 days prior to Visit 1;
* Pregnant or breastfeeding;
* Females of childbearing potential who refuse to use an acceptable method of birth control for the duration of the study. Adequate contraception is defined as hormonal (e.g., oral, injection, transdermal patch, implant, cervical ring), barrier (e.g., condom with spermicide or diaphragm with spermicide), intrauterine device (e.g., IUD), or monogamous relationship with vasectomized partner who has been vasectomized for 6 months or more prior to the subject's study entry;
* Any serious disease, such as:

  * cancer,
  * Autoimmune disease,
  * diabetes mellitus,
  * chronic pulmonary disease,
  * acute or progressive hepatic disease,
  * acute or progressive renal disease;
* Surgery planned during the study period;
* Bleeding diathesis;
* Hypersensitivity to eggs, chicken protein, chicken feathers, influenza viral protein, neomycin or polymyxin or any other component of the study vaccine;
* History of any neurological symptoms or signs following administration of any vaccine, or anaphylactic shock following administration of any vaccine;
* Known or suspected impairment/alteration of immune function, for example, resulting from:

  * Receipt of immunosuppressive therapy (any corticosteroid therapy
  * Receipt of immunostimulants,
  * High risk for developing an immunocompromising disease
Correlation Between Silicone-oil Related Ocular Complications and ITMES Score (CLIN-ITEMS)

Prospective, multicentric, observational study aimed to evaluate the correlation between the value of the InTraocular EMulsion of Silicone oil (ITMES) score assessed at clinical examination and silicone oil-related ocular complications. This will allow to clinically validate the ITEMS score, as clinical tool.

Demographic data and clinical findings, including the ITEMS score, of patients undergoing to vitrectomy and silicone oil tamponade or removal of silicone oil or having one silicone oil-filled eye, will be collected at the baseline and at each follow-up visit (at 1-day, 1-, 3- and 6-month after surgery).

The prognostic performance of the ITEMS score will be evaluated in agreement with the TRIPOD statement.


Eligibility Criteria:
Inclusion Criteria: One eye requiring pars plana vitrectomy and silicone oil/heavy silicone oil tamponade, OR pars plana vitrectomy and removal of silicone oil/heavy silicone oil OR one silicone-oil filled eye.

Exclusion Criteria:

* untreated or uncontrolled ocular disease leading to unacceptable higher risk of intra- and post-operative complications, such as uncontrolled ocular inflammation or infection, untreated ocular malignancy and uncontrolled glaucoma;
* uncontrolled severe systemic disease related to significantly higher operative risk;
* pregnant women due to the specific risks related to supine position during surgery, operative time, risks of retrobulbar anesthesia, and intraoperative and postoperative drugs;
* inability to give written consent.
CE-MRI&CESM in Solid Breast Lesions

Our study aimed to assess the accuracy of CE-SM in comparison to contrast-enhanced breast MRI in the evaluation of solid breast lesions.

Breast cancer is the most common cancer in women, responsible for 23% of cancer in females worldwide (1).

Early detection and accurate diagnosis of breast cancer aims to reduce morbidity and mortality and have essential role in management and improved prognosis of breast cancer (2).

Mammography has been established as the imaging modality for screening and early detection of breast cancer; however, it is accused of having low sensitivity and specificity in women with dense breasts (3).

Contrast-enhanced MRI considered the gold standard method for diagnosis of breast cancer; but, it has many limitations as high cost, long examination time and limited availability (4,5).

Contrast-enhanced spectral mammogram (CESM) is considered now a relatively new imaging modality which can provide both anatomic and functional information of the breast lesion similar to MRI (6).

CESM like contrast-enhanced MRI (CE-MRI) is used to detect angiogenesis of the lesion in the mammography suite. It includes high- and low-energy images during a single compression after contrast injection (7).

The advantage of CESM over MRI is that it is less expensive and easier to perform with shorter examination time. Also, the higher sensitivity of MRI is plagued by numerous false-positive foci of enhancement (8).

Also, CESM can replace MRI in case of patient contraindicating for MRI as patients with pacemakers, aneurysm clips or metal implants, or severe claustrophobia (7).

So, our study aims to determine the value of CESM and answer the question of does CESM could replace CE-MRI in diagnosing breast cancer? so,our study aimed to assess the accuracy of CESM in comparison to contrast-enhanced breast MRI in the evaluation of solid breast lesions.

Eligibility Criteria:
Inclusion Criteria:

* Patients who have previously undergone mammography (MG) and ultrasound and have a solid (BIRADs III and more) breast lesion.

Exclusion Criteria:

* Cystic breast lesions
* BIRADs I and II breast lesions(benign)
* Pregnancy
* History of allergic reaction to iodinated contrast agent
* Renal insufficiency
* Other contraindications to MRI include pacemaker, claustrophobia or metal prosthesis.
Oxygen Insuflation and ArterialDesaturation During Tracheal Intubation in Children

Infants (0-1 yr.) with anticipated difficult airways will be enrolled in the study. Specifically, we will include infants with cleft palate, Pierre Robin, Treacher Collins, trisomy 21, or similar congenital malformations. Patients with American Society of Anesthesiologists physical status scores ≥3 will be excluded, as will those with congenital heart disease and left-to-right shunting. Patients will be randomly assigned to laryngoscopy with or without simultaneous insufflation of oxygen at 4 L/minute. Oxygen will be provided by a flowmeter connected via rigid tubing to the track-mounted endotracheal tube on the AirTraq. Randomization (1:1) will be based on computer-generated codes with random block sizes and stratified by hospital; allocation will be concealed and provided to clinicians via a secure web site that will be accessed shortly before induction of anesthesia.


Eligibility Criteria:
Inclusion Criteria:

* infants (0-2) difficult airways

Exclusion Criteria:

* . Patients with American Society of Anesthesiologists physical status scores ≥3 congenital heart disease left-to-right shunting
Exercise Intervention on Cardiorespiratory Function in HF With DM.

Investigate the effects of exercise training on the cardiopulmonary function and exercise capacity in diabetes mellitus with heart failure.

This research intends to explore the effects of exercise training on the cardiopulmonary function and exercise tolerance of heart failure patients with diabetes mellitus. In addition to the impaired cardiac function, the clinical manifestations of patients with heart failure also shown the inefficiency of pulmonary function, peripheral vascular function, and musculoskeletal system. Due to low exercise tolerance, functional activities and quality of life are impaired. With the high hospitalization rate and high mortality rate, the clinical treatment of heart failure is challenging. At present, exercise has been listed in the guidelines for the treatment of heart failure, and is recommended that patients with heart failure should take regular aerobic exercise training to maintain functional activity and reduce symptoms. Past studies have also suggested that exercise training can help reduce the risk factors of cardiovascular disease and improve part of the cardiovascular function. Furthermore, exercise can improve the quality of life and reduce the hospitalization rate. Although diabetes is a common comorbidity of heart failure, and is a poor prognostic factor that increases the overall risk of heart failure and cardiovascular death, there are few studies in the past to further explore the benefits of exercise training for diabetes with heart failure, although current studies have confirmed that regular exercise can effectively control diabetes. However, the cardiopulmonary function and exercise tolerance of exercise training for diabetes with heart failure still need to be clarified. Therefore, this study aims to investigated the effect of cardiopulmonary function and exercise tolerance in patients with heart failure. The study participants were divided into two groups: usual care group and exercise group. Exercise training involved last for twelve weeks, and then follow up until the sixth week after exercise training. The results of the study are expected to be applied to clinical heart failure rehabilitation. It is expected that through active cardiopulmonary rehabilitation combined with precise and personalized exercise prescriptions, it will prevent deterioration of heart failure and may help improve the clinical practice of heart failure.

Eligibility Criteria:
Inclusion Criteria:

* Heart Failure (NYHA I-III) with diabetes mellitus
* Aged 30-85
* Mini-mental state examination score \> 25

Exclusion Criteria:

* eGFR \< 30mL/min/1.73m2
* Exercise intervention contraindication of heart failure
* Pregnancy
* Uncontrolled disease
Patients Who Underwent Thyroid Ultrasonography at Our Institution Were Selected for Shear Wave Elastography of Thyroid Nodules, and the Maximum and Mean Values of the Modulus of Elasticity of the Nodules in Transverse and Longitudinal Sections Were Analyzed.

The objective of this observational study was to evaluate the effect of transverse and longitudinal sections on the measurement of thyroid nodule stiffness by shear wave elastography. The main questions it aims to answer are: (i) to compare the diagnostic efficacy of different section orientations of shear wave elastography for the diagnosis of benign and malignant thyroid nodules; (ii) to analyze the correlation between the two orientations of transverse and longitudinal sections of shear wave elastography; and (iii) to compare the reliability and consistency of the two orientations of transverse and longitudinal sections of shear wave elastography for the diagnosis of thyroid nodules. Participants will undergo routine ultrasound examination of the thyroid gland and shear wave elastography, and the measured modulus of elasticity of the nodules in both transverse and longitudinal sections will be recorded.


Eligibility Criteria:
Inclusion Criteria:

All patients underwent preoperative shear-wave elastography ultrasonography; thyroid nodules ranged from 3 to 20 mm in size; all nodules underwent puncture biopsy or surgery to obtain pathologic results.

Exclusion Criteria:

Unavailability of pathology results for various reasons; poor quality of ultrasound images; missing data.
A Study of the Effectiveness and Safety of SP2086 to Treat Type 2 Diabetes

SP2086 is a new dipeptidy1 peptidase(DPP)-4 inhibitors. This study aims to explore the effective dose range of SP2086 in Patients with type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* 20 Years to 70 Years ,Male and Female diagnosed with type 2 diabetes mellitus
* Patients not on an oral antihyperglycemic agent (OHA) with 7.0% ≤HbA1C ≤10.5%,or not on an OHA for 3 months with 7.0% ≤HbA1C ≤10.5%
* BMI 19\~35 kg/m2

Exclusion Criteria:

* Patient has history of type 1 diabetes mellitus
* Patient has history of ketoacidosis
* Patient has history of severe unconscious hypoglycemosis
* Patient has history of acute and chronic pancreatitis or pancreatic injury that may lead to high risk of pancreatitis
* Patient has history of decompensated heart failure (NYHA class III and IV), unstable angina, stroke or transient ischemic attack, myocardial infarction, persistence and clinical
* Patient has history of a history of hypertension, and after antihypertensive treatment, systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg
* Patient has severe liver or kidney disease,alanine aminotransferase \>2×UNL, Aspartate Aminotransferase \>2×upper normal limit(UNL)；total bilirubin \>2×UNL； creatinine\>1.5 mg/dL (Male,132.6μmol/L) ，\>1.4 mg/dL(Female，123.8μmol/L)
* Patient has severe chronic gastrointestinal disease or therapy that may affect drug absorption, such as gastrointestinal surgery
* Patient has severe haematological diseases or other diseases leading to hemolyze and red blood cell unstable (malaria、haemolytic anaemia eg. )
* Patient has other endocrine diseases, for example hyperthyroidism、hypothyroidism、hypercortisolism、multiple endocrine neoplasia and so on
* Patient has history of malignancy
* Patient has history of alcohol or drug abuse
The Pain Pen for Breakthrough Cancer Pain

The purpose of this study is to see whether injection of hydromorphone through a subcutaneous injection device is more effective in treating breakthrough cancer pain than oral morphine.

Breakthrough pain is an exacerbation of severe pain that occurs on a background of otherwise controlled pain. Breakthrough pain is common in patients with advanced cancer. Current medications to treat breakthrough pain include oral immediate release opioid formulations and more recently oral transmucosal fentanyl citrate.

The pain pen study is a randomized controlled double blind cross-over study comparing the efficacy of oral immediate release morphine with that of subcutaneous hydromorphone, injected through a so called pain pen, on breakthrough pain in cancer patients. Preliminary experience with the pain pen suggests that it has a more rapid time of onset of pain relief than oral formulations.

Eligibility Criteria:
Inclusion Criteria:

* Stable cancer pain requiring the equivalent of 60-1000 mg oral morphine/day
* 1-4 breakthrough pain episodes/day
* Patients must be able, in the opinion of the investigator, to fully comply with trial requirements
* Patients who have given written informed consent

Exclusion Criteria:

* Uncontrolled pain
* Women who are pregnant, lactating or intend to become pregnant
* Cardiopulmonary disease that would increase the risk of opioids
* Neurologic or psychiatric disease that would compromise data collection
* Recently started chemotherapy or radiotherapy in as far as it would be effective in lowering breakthrough pain
Study of GBT009 for Treatment of Incisional Wounds Following Breast Reconstruction Surgery

The primary objective of this study is to assess whether intradermal injections of GBT009 along full thickness incisions following surgery results in an improvement in scar appearance.


Eligibility Criteria:
Inclusion Criteria: Subjects must meet all of the following criteria to be considered eligible to participate in the study:

* be a female between 18 and 70 years of age, inclusive
* have a body mass index ≤ 32 kg/m2 and a body weight between 50 and 95 kg, inclusive
* be scheduled for a mastectomy with breast reconstruction surgery using an abdominal flap technique
* for women diagnosed with breast cancer, has standard of care treatment for breast cancer prior to surgery and will have standard of care treatment for breast cancer after surgery
* for subjects of childbearing potential, be surgically sterile or using an insertable, injectable, transdermal, or combination oral contraceptive approved by the FDA through completion of the study and have negative results on a serum pregnancy test done before administration of study medication (women who are postmenopausal \[no menses for at least 2 years\] are also eligible to participate)
* be able to understand the study procedures, agree to participate in the study program, and voluntarily provide written informed consent

Exclusion Criteria: Subjects who meet any of the following criteria will be excluded from participating in the study:

* have clinically significant laboratory abnormalities at screening
* have, as determined by the investigator or the sponsor's medical monitor, a history or clinical manifestations of significant renal, hepatic, cardiovascular, metabolic, neurologic, psychiatric, coagulopathic disorder or other condition that would preclude participation in the study
* have received treatment for a severe, uncontrolled inflammatory disease or allergic condition within three months of screening
* have a life expectancy ≤ 2 years
* have a history of alcoholism or drug addiction or abuse within 5 years
* have evidence of a clinically significant abnormality upon evaluation of 12 lead ECG
* have evidence of any past or present clinically significant medical condition, including skin disease, that would impair wound healing
* have a history of keloid scar formation
* have existing scarring in the abdominal area of study that would interfere with the efficacy assessments
* have a history of (within the past 5 years) or an active malignancy, other than breast cancer
* have a breast cancer that has been staged at Stage IIIB, IIIC or IV
* have received a cytotoxic agent or have been treated with radiation within 90 days of screening and/or, in the opinion of the investigator, will likely require treatment in the 30 day period following the administration of study medication
* have received anticoagulation medication within 5 days of dosing with study medication
* have participated in any study involving an investigational product within 30 days before dosing with study medication
* have routinely used tobacco products within 6 months preceding the study period
Erector Spinae Plane Block for Minimally Invasive Mitral Valve Surgery

The goal of this project is to study whether local anesthetic via the erector spinae plane (ESP) block may be beneficial in minimally invasive mitral valve surgery (MIMVS).

This is a double blinded randomized controlled trial comparing a control group receiving cryoablation and sham block with an intervention group receiving cryoablation and ESP catheter. The primary outcome is total oral morphine equivalent (OME) consumption within the first 48 hours of recovery including intra-operative usage. Secondary outcomes to be evaluated would include pain scores, functional milestones like time to extubation, time to first PO intake, time to ambulation, time to chest tube removal, length of ICU and total hospital stay, complications, and patient satisfaction.

Eligibility Criteria:
Inclusion Criteria:

* Elective mitral valve repair or replacement
* Planned minimally invasive approach

Exclusion Criteria:

* Non-English speaking
* Emergency surgery
* Planned or unplanned sternotomy
* Previous history of sternotomy and cardiac surgery
* Allergy to ropivacaine
* Patients taking more than 60 OMEs per day
* Patients with coagulopathy or taking anticoagulant with laboratory findings contraindicated for ESP catheter