cyrilzakka/clinical-trials huggingface dataset:
A Study of Pressure Waveform Analysis in Coronary Artery-II

The goal of this observational study is to test the feasibility of intracoronary adenosine administration during coronary flow reserve(CFR) and index of microcirculatory resistance(IMR) assessment in a population with angina. The main questions it aims to answer are:

* Repeatability of CFR and IMR assessment while hyperemia with intracoronary adenosine was administered.
* Evaluate the correlation of the intrinsic signal of coronary waveform versus physiologic ischemia, while defined by fractional flow reserve(FFR) and CFR respectively.
* The predictive value of FFR, CFR, and IMR on major adverse cardiovascular outcomes in 3 years Participants will undergo FFR, CFR, and IMR assessments in the catheterization laboratory of the National Taiwan University Hospital Hsin-Chu Branch, then clinical events follow up for 3 years.


Eligibility Criteria:
Inclusion Criteria:

* Participants with angina

Exclusion Criteria:

* Severe valvular heart disease
* History of asthma
* Heart rate less than 50 beats per minute
* systolic blood pressure less than 90 mmHg
Safety, Tolerability, and Immunogenicity of a Cytomegalovirus DNA Vaccine

If the participant decides to take part in the study, the participant will need to do the following:

Visit the study clinic up to 10 times and be available for a reasonable amount of follow up phone calls to see how the participant is doing.

The participant will receive three doses of vaccine injected into the muscle of the upper arm. After each injection the participant will be asked to remain at the study site for at least 30 minutes after the participant receives the study vaccine.

The results of all of the participants blood tests, just like all other laboratory test results, will be provided to the Investigators, Sponsor, and vaccine developer. Positive HIV and viral hepatitis test results will be reportable to local health authorities according to local laws.

The participant will be asked to refrain from excessive physical activities and alcohol consumption within 2 days before each clinic visit to avoid possible confusing effects on laboratory tests.

Up to 10 normal healthy adult female subjects 18 to 35 years of age will be enrolled in this trial. A total of 3 injections of the vaccine will be given at Days 0, 28 (+4 days), and 56 (+4 days). There are follow-up visits 7 days after each vaccination, one follow-up visit 28 days after the 3rd (last) vaccination, and a final visit 3 months later. Blood and urine samples will be collected at each vaccination and follow-up visit. The participant will be asked to complete a telephone call follow-up at 1 year after receiving the last vaccination.

Participants will be required to complete subject diary cards throughout the study until the telephone call follow-up at approximately Day 420 (i.e., 12 months following the 3rd and final dose scheduled for Day 56). Diary cards will be reviewed with the study staff at each visit and during the Day 420 telephone call.

Eligibility Criteria:
Inclusion Criteria:

* Healthy female adults, 18 to 35 years of age
* Able and willing to be followed for approximately 15 months
* Lack serum antibodies specific for CMV
* Able to provide informed consent

Exclusion Criteria:

* History of receiving any previous CMV vaccine
* Pregnant, trying to become pregnant, or breastfeeding
* Receipt or donation of blood, blood products, or plasma within 30 days of the initial injection
* Clinically significant findings from clinical evaluation or laboratory tests, evidence of medical disease(s) or medical/psychiatric condition(s), or unable to participate due to occupation or other social reasons
* Use of immunomodulatory therapy (drugs that suppress the immune system) within the past 6 months or other medications or nutritional supplements as determined by the study investigators that may interfere with the vaccine response, or increase safety risks to the participant, that have been taken within 30 days prior to the initial injection on Day 0
* Antinuclear antibody (ANA) titer \>1:80
* Body mass index (BMI) \>30
* Less than 18 years of age or older than 35 years of age
* No access to a telephone
Color Doppler Ultrasonography in Prediction of Arteriovenous Fistula Maturation in Hemodialysis Patients

The transplant is the definitive treatment of renal insufficiency, in our days. While waiting for it, the arteriovenous fistula surgery is standard procedure.

Ultrasound is the main method of diagnostic imaging, because of its low cost, noninvasive without ionizing radiation associated or iodized contrast.

Vascular procedures and their complications represent a major cause of morbidity hospitalization and cost for patients in hemodialysis .

Many fistulas do not mature appropriately for being used in dialysis. So,The early recognition through the ultrasound examination of problems in the arteriovenous fistula maturation or possible complications that may compromise their viability, offers the opportunity of correction or appropriate treatment .

Criteria for maturation after arteriovenous fistula creation:

* Vein diameter larger than 4 mm remote from the site of fistula.
* Vein located at a depth of \<5 mm from skin surface.

Eligibility Criteria:
Inclusion Criteria:

* 1) Patients Of Chronic Renal Failure With Newly Placed AVF. 2)Clinically Stable Patients For Assessment Of Maturation Of AVF. 3) Complaints Of Hand Pain Or Numbness Following Creation Of The Access.

Exclusion Criteria:

* 1)Previously Failed AV Fistulas. 2)Deformed Or Scarred Upper Limb.
Interest of Fluorescein in Fluorescence-guided Resection of Gliomas (FLEGME)

Fluorescence guidance is a safe and efficient tool for glioblastomas resection. The most widely used technique is based on 5-aminolevulinic acid (5ala), which stains glioblastoma cells through a metabolic abnormality and thus helps in defining tumoral edges through a modified microscope. A multicentric, randomized study comparing 5ala guided surgery with conventional procedures showed that this technique doubles the rate of complete removal on post-operative magnetic resonance imaging (MRI), and increases the 6 months progression-free survival. More recently, fluorescein appeared as an interesting alternative fluorophore for glioblastomas, with a highly reduced cost (2.5 euros versus 1000 euros per dose). However its use remains scarcely studied and its clinical benefit unsure. In that context, the investigators propose a randomized trial comparing conventional " white light " surgery with fluorescein-guided resection of glioblastomas, in order to assess the relevance of this technique in glioblastomas removal.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 79
* Karnofsky index \> 70 %
* Brain MRI showing a parenchymal lesion with typical features of glioblastoma, \< 1week
* Achievable gross total removal, as assessed by the neurosurgical staff
* Written consent

Exclusion Criteria:

* Contraindication to fluorescein
* Contraindication to MRI
* History of brain surgery \<6 months
* Guardianship, tutelage or deprivation of liberty
* Pregnancy or breastfeeding
* Participation to other interventional clinical studies
An Exploratory Study of Caregiver Burden Among Family Caregivers of Patients With Cancer

This study will look at caregiver burden and the coping behavior of caregivers of patients with cancer. Through this study, the investigators will identify the relationship between cognitive dysfunction (measured as a proxy rating by the caregiver), resilience, social support, cognitive appraisal, coping behavior, and caregiver burden, anxiety, and depression among family caregivers of patients with cancer.

The goal of this study is to explore caregiver burden and the coping behavior of caregivers of patients with cancer. It has been documented that non-professional caregivers and long-term care providers to patients with cancer receive little preparation, information, or support to perform their vital role. Through this study, the investigators will identify the relationship between cognitive dysfunction, resilience, social support, cognitive appraisal, coping behavior, and caregiver burden, anxiety, and depression among family caregivers of patients with cancer. The findings of this study will direct future intervention studies to reduce caregiver burden and improve outcomes for the many individuals caring for family members with cancer.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Self-identified primary caregiver of patients with cancer
* Co-residence with the patient
* Providing a minimum of 4 hours of direct care for at least 3 days per week
* Able to speak, read, and understand English
* Willing to participate in completion of surveys

Exclusion Criteria:

* Professional or paid caregivers
Target Effect-site Concentration of Remifentanil in Transperineal Prostate Puncture

The research about the target effect-site concentration of remifentanil, inhibiting stress reaction of the perineal prostate puncture when Dexmedetomidine being continuous pumping

Patients who were scheduled to undergo transperineal prostate puncture and biopsy were recruited into our study. In all patients, dexmedetomidine was injected at a bolus of 0.6 mg/kg and then continuously infused at 0.6 ug/kg/h using the conventional continuous microinfusion pump. the target Effect-site concentration of remifentanil was determined by sequential method. The first target effect-site concentration of remifentanil was set to 4.5ng/ml, the difference of adjacent target concentration was 0.5 ng/ml. Cardiovascular positive reaction was defined as the changes of heart rate or systolic blood pressure was more than 15% compared with baseline values, or body movement observed. The adjacent target concentration difference was adjusted to 0.2 ng/ml after 3 negative and positive reaction cycles. If the first had a cardiovascular positive reaction, the target concentration of remifentanil increased by a concentration gradient. Conversely, the target concentration of remifentanil decreased by a concentration gradient.

Eligibility Criteria:
Inclusion Criteria:

* patients of perineal prostate puncture

Exclusion Criteria:

* sinus bradycardia or atrioventricular block serious heart, brain, lung, liver, kidney, and metabolic disease allergy for dexmedetomidine or opioid
Strategies for Implementing a Postpartum Lifestyle Intervention in WIC Clinics

The primary objective of the STRIVE study is to compare two implementation strategies for Diabetes Prevention Program delivery: an in-person health coach strategy (standard 24 in-person sessions at WIC clinics) vs. a multifaceted technology-assisted health coach implementation strategy (12 in-person sessions at WIC clinics supplemented by technology support) on implementation and health-related outcomes in postpartum women.

The overall objective of this project is to study the implementation, effectiveness, and sustainability of implementing the Diabetes Prevention Program (DPP) in postpartum women who receive services from WIC. In this effectiveness-implementation type III cluster-randomized trial, we will compare two implementation strategies for DPP delivery: an in-person health coach-led implementation strategy (standard 24 in-person sessions) vs. a multifaceted technology-assisted health coach implementation strategy (12 in-person sessions supplemented by technology tools).

Eighteen clinics will be randomized to the multifaceted technology-assisted health coach strategy and 18 to the in-person health coach-led strategy. A total of 900 postpartum participants (25 per clinic) will be recruited into the study and followed for 12 months for implementation and effectiveness outcomes. A post-intervention study visit will take place 6 months after the end of the 12-month intervention to evaluate the sustainability of the implementation strategies.

Eligibility Criteria:
Inclusion Criteria for Clinics:

* Serve a large number of WIC postpartum participants
* Willing and able to provide space for the study

Inclusion Criteria for Participants:

* Age 18 or older
* Gave birth in the past 6 weeks to 12 months
* Obesity or history of gestational diabetes mellitus (Current BMI ≥30 kg/m², OR Medical-record documented history of gestational diabetes mellitus and BMI ≥25 kg/m²)
* No self-reported diabetes (other than gestational diabetes)
* Hemoglobin A1c \<6.5%
* Not currently pregnant or planning to become pregnant in the next 6 months
* No plans to move outside of the study region in the next 12 months
* Access to a smartphone
* Willing and able to participate in the intervention and provide consent
* Not an immediate family member of the staff at the WIC clinic
* Other concerns regarding ability to meet trial requirements, at the discretion of the principal investigator or study coordinator
Impact Factors to Success Without Posterior Wall Puncture Using Dynamic Approach

The study is designed to evaluate and validate impact factors to success and complication using ultrasound guided short-axis out-of-plane dynamic approach, and validate the impaction.

The study including two phase: observational phase and validation phase. In observational phase, factors relative to success catheterization without posterior puncture and success in first attempt are evaluated. In validation phase, patients are randomized into different depth group with or without injection of saline. Success without posterior wall puncture, success in first attempt and overall, catheterization time are compared between groups.

Eligibility Criteria:
Inclusion Criteria:

* requirement of radial arterial catheterization during perioperative period
* within cardiac-vascular disease
* written consent

Exclusion Criteria:

* contraindication to radial arterial catheterization
* abnormal artery evaluated by ultrasonography
Laparoscopic Surgical Systems for Gynecological and Remote Surgical Treatment.

Remote robot-assisted laparoscopic surgery will be performed for gynecological surgical treatment through 5G network, while the safety and effectiveness will be studied.

This clinical study adopts a prospective, single-center, single-arm exploratory design. Remote robot-assisted laparoscopic surgery will be performed for gynecological surgical treatment through 5G network, while the safety and effectiveness will be studied.

The research process consists of three stages: the screening phase, the treatment phase and the follow-up phase. The screening phase: On the premise of meeting the inclusion and exclusion criteria, patients who voluntarily participate in robot-assisted surgery are planned to be included. Obtain written informed consent from the subjects, collect clinical data (which may include previous medical examination results), and complete relevant examinations. The treatment phase: The laparoscopic surgical system is combined with 5G network and communication technology for the surgical operation process. The follow-up phase: The physician's observational follow-up of the subjects in the study will continue up to one month post-surgery, and may be extended if necessary. During these three phases, subjects will need to undergo some medical observations or examinations to assess safety and efficacy indicators.

Eligibility Criteria:
Inclusion Criteria:

* Patients who require endoscopic surgery
* Voluntarily participate in this study and sign informed consent in writing

Exclusion Criteria:

* Patients with malignant tumors with clinical stage IV
* Those who require emergency surgery
* Presence of active bleeding, severe abnormal coagulopathy (prothrombin time (PT) or international normalized ratio (INR) greater than 1.5 times the upper limit of normal), or platelet count \&lt; 80×10\^9/L
* Patient has severe cardiovascular or circulatory disease and cannot tolerate surgery
* Participated in other clinical trials in the past 1 month
* Inability to understand trial requirements, or inability to complete the study follow-up plan
* Other conditions that are considered by the investigator to be inappropriate for enrollment
Ascending Single-Dose Study to Evaluate VIA-3196 in Healthy Subjects

This is a single-center, randomized, double-blind, placebo-controlled, ascending single-dose study of VIA-3196 to evaluate the Safety, Pharmacokinetics and Pharmacodynamics of VIA-3196 in Healthy Subjects. Study dosing is organized into cohorts corresponding to escalating doses of VIA-3196 or matching placebo.


Eligibility Criteria:
Inclusion Criteria:

* The subject must be willing and able to provide written informed consent.
* Healthy, non-smoking, males and females between the ages of 18 and 55 years of age (inclusive).
* If female, the subject is of non-child bearing potential (i.e., surgically \[bilateral oophorectomy, hysterectomy, or tubal ligation\] or naturally sterile \[\>12 consecutive months without menses\]). Verify by FSH at screening as appropriate.
* Body weight \> 50 kg and BMI between 18 and 30 kg/m2 (inclusive).
* LDL cholesterol \> 85 mg/dL.
* No clinically significant abnormal findings on blood pressure, heart rate, physical examination, clinical laboratory tests or 12-lead ECG.

Key Exclusion Criteria:

* History of thyroid disorder or abnormal thyroid function tests at screening. Repeat testing is allowed at the discretion of the Investigator.
* History of unexplained syncope.
* History of hepatobiliary disease; or AST, ALT or direct bilirubin greater than the upper limit of reference range at screening.
* Positive screening test for HIV antibody, Hepatitis B surface antigen or Hepatitis C antibody.
* Abnormal screening ECG: including machine-read QTc \>450 msec, QRS \>110 msec, intermittent bundle branch block, frequent premature atrial or premature ventricular contractions, or any rhythm other than normal sinus rhythm which is interpreted by the Investigator to be clinically significant.
* History of sensitivity to a similar study drug (e.g., Karo Bio KB2115 or Metabasis MB7811), or a history of important drug or other allergy (except for untreated, asymptomatic seasonal allergies at time of dosing).
* Sensitivity to thyroid medication.
* History of asthma, or intolerance to beta-blockers.
* Use of acetaminophen within 7 days before dosing and throughout the study.
* History of regular use of tobacco or nicotine containing products within the past 6 months.
* Positive urine drug screen or alcohol test at screening.
Effect of Tyrosine on Behavioral, Physiological and Nutritional Status During Survive, Evade, Resist, Escape (SERE) School

The objective of the proposed research is to determine if tyrosine, an amino acid found in protein-containing foods, will mitigate the cognitive deficits and adverse effects on behavior and mood produced by exposure to military stress. This study will be conducted at the Army Survive, Evade, Resist, Escape (SERE) school at Fort Bragg, NC.

Tyrosine is the dietary precursor of the catecholamine norepinephrine, a key brain neurotransmitter that is critical for the central nervous system (CNS) response to various types of acute stress. Psychological stress increases catecholamine turnover in the brain, increasing the requirement for tyrosine to support synthesis of norepinephrine. Animal and human studies have shown that tyrosine supplementation can produce beneficial effects on cognitive and physiological functions during exposure to a variety of acute stressors.

This project will determine if volunteers treated with supplemental tyrosine during stressful phases of SERE training experience less degradation in cognitive performance and mood than volunteers treated with placebo. Tyrosine or placebo will be administered in a specially developed food bar provided to volunteers. The bar is part of a prototype of ration-component designed for use during assault operations. A between-subjects, double blind experimental design will be employed. Tyrosine, an amino acid found in most protein-containing foods, has been tested in hundreds of volunteers without adverse effects.

Approximately 100 volunteers will be recruited from several SERE classes to ensure up to 82 volunteers complete the study. They will be tested during several portions of SERE. A comprehensive but brief battery of cognitive tests, as well as saliva and blood samples, will be collected in a manner that does not interfere with ongoing training.

Hypotheses:

1. The adverse effects of psychological stress on cognitive performance and mood during SERE school will be reduced when volunteers are given supplemental tyrosine compared to placebo treatment.
2. Supplemental tyrosine will reduce release of proinflammatory cytokines that may be increased by the stressful activities of SERE school.


Eligibility Criteria:
Inclusion Criteria:

* MUST BE ACTIVE DUTY ARMY SOLDIERS ENROLLED IN SPECIAL FORCES TRAINING AT US ARMY SERE SCHOOL
* Fluent in English (non-native English speakers can be enrolled)

Exclusion Criteria:

* Allergy to dairy products
* blood donation within 8 weeks of study start
Effect of a Community-based Nursing Intervention on Mortality in Chronically Ill Older Adults

Care coordination, disease management, geriatric care management, and preventive programs for chronically ill older adults vary in design and their impact on long-term health outcomes is not well established. This study investigates whether a community-based nursing intervention improves longevity and impact on cardiovascular risk factors in this population. The results reflect the impact of one of the study sites (Health Quality Partners) selected by the Centers for Medicare and Medicaid Services (CMS) to participate in the Medicare Coordinated Care Demonstration, a national demonstration designed to identify promising models of care coordination for chronically ill older adults. The study began in April 2002.

The community-based nursing care management model developed by Health Quality Partners represents a comprehensive set of integrated preventive and monitoring services designed for older adults living with chronic diseases. The individual programs and services integrated within the model were selected on the basis of previously demonstrated evidence of effectiveness. The model is delivered in the communities in which participants reside. Care is delivered through in person contacts, (1 to 1 and group) as well as by telephone. In person contacts occur in the home, in readily accessible community and faith-based organizations, health facilities, or the offices of Health Quality Partners. Efforts are made to contact participants in the intervention group at least monthly with care continued until death, voluntary disenrollment, mandatory disenrollment due to changes in insurance coverage, relocation out of the service area, or change in long term level of care (e.g., nursing home placement, hospice).

Eligibility Criteria:
Inclusion Criteria:

* Aged 65 years and older
* Medicare Part A and B traditional, fee for service insurance coverage
* One or more of the following chronic conditions:
* Heart failure
* Coronary Disease
* Diabetes mellitus
* Asthma
* Hypertension
* Hypercholesterolemia
* A Geriatric Risk Stratification Level of 2 or more based on a pre-enrollment screening tool
* Geriatric Risk Stratification Level changed in Sep 2006 to a Level of 3 or more
* Willingness of the participant's primary care provider to collaborate

Exclusion Criteria:

* Amyotrophic lateral sclerosis
* Alzheimer's disease
* Dementia
* Diagnosis or history of cancer (other than skin) in the past 5 years
* End-stage renal disease
* Life expectancy on enrollment less than 6 months
* HIV or AIDS
* Huntington's disease
* Organ transplant candidate
* Psychosis or schizophrenia
* Resident of or imminent plan for long-term nursing home placement
* Seasonal relocation outside of the area for more than 4 weeks per year
* Anyone receiving service from Health Quality Partners in the past