cyrilzakka/clinical-trials huggingface dataset:
A Trial to Evaluate the Efficacy of Immunoglobulin Plus Steroid for Prevention of Coronary Artery Abnormalities in Taiwanese Refractory Kawasaki Disease (RAST Study)

Background:

Kawasaki disease (KD), most popular acquired heart disease in childhood, is characterized by diffuse vasculitis, especially on the middle-sized muscular arteries. IVIG and aspirin are currently standard treatment. However, 10-15% of KD patients have poor response to such treatment and suffer from higher risk of coronary involvement. Recently, combination of prednisolone and IVIG has been shown effective to lower the chance of refractory to IVIG treatment and subsequent coronary lesions. However, no randomized trial on the steroid efficacy was ever conducted in Taiwan.

Aim:

Prospectively randomized open-label trial to evaluate the add-on effect of prednisolone in the refractory KD children.

Methods:

For the KD patients with fever persisted or relapsed 24 hours after the ending of IVIG infusion, they will be randomized into two group: IVIG group (I) and IVIG + prednisolone group (P). The KD patients in the P group will have in addition to IVIG, oral prednisolone 2mg/kg/day for at least 5 days. The difference in the response rate and percentage of coronary involvement will be compared between I and P groups.

Predicted results:

We plan to enroll 100 refractory KD patients, 50 patients for each group. We predict the risk of coronary involvement can be reduced from 30% to 15%.


Eligibility Criteria:
Inclusion Criteria:

* KD (Kawasaki disease) patients who failed to respond to the initial IVIG as those who had persistent fever that lasted for more than 24 hours (nonresponse to the initial IVIG) or recrudescent fever associated with KD symptoms after an afebrile period (relapse).

Exclusion Criteria:

* KD patients, those diagnosed on or after day 9 of illness (the first illness day was defined as the day of fever onset), those with coronary artery abnormalities before enrolment, those who were afebrile before enrolment, those who had received steroids (oral, intravenous, intramuscular, or subcutaneous) in the 30 days before the study or intravenous immunoglobulin in the previous 180 days, those with concomitant severe medical disorders (eg, immunodeficiency, chromosomal anomalies, congenital heart diseases, metabolic diseases, nephritis, collagen diseases), and those with suspected infectious disease, including sepsis, septic meningitis, peritonitis, bacterial pneumonia, varicella, and influenza.
Myocardial Infarction and Non-contraceptive Estrogen Use

To evaluate whether the use of noncontraceptive estrogen influenced the incidence of first myocardial infarction in women.

BACKGROUND:

The use of noncontraceptive estrogens declined after evidence was published that they increase the risk of endometrial cancer. Nonetheless, they are still used commonly and for long periods, especially by hysterectomized women. Use of the drugs has increased recently, perhaps because the drugs have been recommended as prophylaxis against osteoporosis. The drugs are also being promoted for use in conjunction with a progestin, because it is thought that the combination may protect against endometrial cancer. Little is known about the effects of these drug regimens on myocardial infarction risk, and some progestins (in particular the 19-norprogestins) are thought to influence lipid profiles unfavorably. Insofar as myocardial infarction is a major cause of morbidity and mortality in women beyond age 49, an effect of these drugs, either beneficial or adverse, on myocardial infarction risk is of considerable public health importance.

DESIGN NARRATIVE:

The design was that of a case-control study. Cases were selected from women admitted for the first episode of myocardial infarction to any of the participating hospitals in the Boston area. For each case, a control was selected from town lists of women living in the same neighborhood as the case and in the same five year age group. Cases were interviewed by telephone after discharge from the hospital, and the corresponding control was interviewed within a week or two of the case interview.

Information was obtained on: the timing and duration of non-contraceptive estrogen use, the names of the preparations and reasons for starting and stopping each episode of use; other drug use particularly oral contraceptives, aspirin, phenylpropanolamine; age at menopause; cigarette smoking; height and weight; histories of previous myocardial infarction, hypertension, pre-eclamptic toxemia, diabetes mellitus, angina pectoris and abnormal serum lipids; reproductive history; alcohol and coffee consumption; personality type based on the Framingham Type A Scale; family history of myocardial infarction; exercise; socioeconomic and life style factors; number of physician visits in last two years and total number of hospital admissions.

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

Eligibility Criteria:
No eligibility criteria
Capnogram and Fluid Responsiveness

Predicting fluid responsiveness in critically ill patients is of paramount importance. It can help define an adequate fluid balance. Overzealous fluid administration is poorly tolerated and has been associated with poor outcomes but so has insufficient administration. Currently available predictors of fluid responsiveness rely on invasive monitors and require patients to be on mechanical ventilation. It is thus important to develop non invasive novel methods to assess fluid responsiveness to provide an accurate management for a favorable outcome. We propose a readily available non-invasive method that relies on improvement of the ventilation perfusion mismatch as recorded by end tidal CO2.

Ventilation of physiologic dead space is part of a spectrum of mismatch between ventilation and perfusion of the lungs. The extent of pulmonary dead space varies depending on factors affecting pulmonary perfusion (e.g. pulmonary capillary hydrostatic pressure) and alveolar pressure (e.g. positive pressure ventilation). Compromised pulmonary capillary perfusion can lead to ventilation-perfusion mismatch in a patient with clear conductive airway and adequate alveolar oxygen pressure. Alveolar dead space results in decreased CO2 exchange that translates into lower levels of expired CO2.

Stroke volume of the right ventricle is a major determinant of the pulmonary capillary perfusion. Right ventricular cardiac output can be increased by passive lower limb elevation maneuver, which ultimately results in improvement of the ventilation to perfusion ratio. This effect leads to a higher participation of perfused (and ventilated) alveolar units in gas exchange and narrowing of the gradient between arterial and expired CO2 concentration. Performing a passive leg raising (PLR) maneuver leads to stroke volume enhancement in both healthy patients and in those experiencing hemodynamic instability. Responsiveness to PLR can be assessed by different methods including echocardiography and pulse pressure variation. Left ventricular cardiac output (LVCO) can be easily measured by transthoracic echo and be used as a surrogate of right ventricular preload changes. LVCO can thus be used to assess the fluid responsiveness of PLR and the effects of on end tidal CO2 that ensue.

We propose this study to test the hypothesis that expired CO2 is a reliable predictor of fluid responsiveness after performance of the PLR maneuver, based on the assumption that increasing right ventricular output causes a reduction of the ventilation to perfusion ratio, leading to increased levels of expired CO2. T


Eligibility Criteria:
Inclusion Criteria:

* Age older than 18 years

Exclusion Criteria:

* Cardiovascular and respiratory disease reported by the participant
Female Sexual Dysfunction in Renal Failure

A myriad of sexual problems affect men and women with chronic kidney disease (CKD), including decreased libido, erectile dysfunction, dysmenorrhea, and infertility. Menstrual abnormalities are common in CKD and many women are an-ovulatory .

Causes of sexual dysfunction in CKD include hormonal alterations along with vascular, neurologic, psychogenic, and other factors, such as medications, contribute to the development of sexual dysfunction . Sexual dysfunction in females is mainly due to hormonal factors and manifests mainly as menstrual irregularities, amenorrhea, lack of vaginal lubrication, and failure to conceive.

Hormonal changes in chronic kidney disease are seen in prolactine, gonadotropins, and gonadal hormones. In women with CKD, elevated levels of follicle-stimulating hormone (FSH) and luteinizing hormone (LH) are common. These hormonal changes are detected in the early stages of kidney disease and progressively worsen as kidney disease progresse .

. Women with chronic renal failure commonly have elevated circulating prolactin levels. As in men with chronic renal failure, the hypersecretion of prolactin in this setting appears to be autonomous, as it is resistant to maneuvers designed to stimulate or inhibit its release.

It has been suggested that the elevated prolactin levels may impair hypothalamic-pituitary function and contribute to sexual dysfunction and galactorrhea in these patients. However, uremic women treated with bromocryptine rarely resume normal menses and continue to complain of galactorrhea (if present), despite normalization of the plasma prolactin concentration. Thus, factors other than hyperprolactinemia must be important in this setting .

Eligibility Criteria:
Inclusion Criteria:

* -Female patients with chronic renal failure (eGFR \<15 ml/min/1.7m2 ) on dialysis or not.
* Age from 18 to 45 years old.
* Married.
* Sexually active during the last 6 monthes.

Exclusion Criteria:

* Pregnant women.
* Other medical diseases ( diabetes mellitus ,cardiac disorders ,neurological disorders and other systematic diseases).
* Taking medications affect sexuality function e.g. antidepressant drugs.
Citrulline Supplementation On Vascular Responsiveness and Function in Postmenopausal Women

The objective of this project is to provide evidence that L-Citrulline (L-CIT) supplementation can improve vascular function at rest and in response to exercise in postmenopausal women.

L-CIT is a non-essential amino acid that is a precursor to L-arginine, the substrate used to produce an important vasodilatory molecule called nitric oxide. The purpose of this study is to identify the effects of 6 grams of L-CIT for 4 weeks on vascular function (endothelial function, blood flow, muscle oxygenation, and blood pressure) at rest and in response to different stressors (cold pressor test, isometric and dynamic exercise).

Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal (absence of menstruation \> 1 year) between the ages of 50 - 79 years.
* Sedentary ( \< 120 minutes of exercise/week)
* Resting systolic blood pressure \< 150 mmHg and diastolic blood pressure \< 90 mmHg
* Not participating as a subject in another study for at least 2 months prior to the study and for the duration of the study
* Willingness to abstain from food supplements 1 month prior to the start of the study and throughout the duration of the study

Exclusion Criteria:

* Body mass index ≥ 40
* Currently taking more than one vasoactive drug for blood pressure control
* Cardiometabolic diseases or other chronic diseases
* Taking hormone replacement therapy 3 months prior to the study
* Current or prior use of tobacco products
* More than a moderate intake of alcohol
* Use of medications and/or supplements that may affect outcome variables
* Musculoskeletal disorders that will prevent exercise performance
South Korean Study to Prevent Cognitive Impairment and Protect Brain Health Through Lifestyle Intervention

This study evaluates acceptability and efficacy of multidomain intervention program to prevent cognitive impairment and protect brain health in Korean at-risk elderly. A third of participants will receive facility-based intervention for 6 months, a third will receive home-based intervention for 6 months, and a third is waiting list controls.

Despite extensive research in the field of Alzheimer's disease (AD), no treatment has yet been developed to modify the progression of AD. Therefore, it is important to manage vascular and metabolic risk factors, to eat healthy foods, to exercise, and to participate in social activities to prevent dementia. The FINGER study showed that the multi-domain intervention program is effective to prevent cognitive impairment and disability in elderly.

In South Korea, exercise and leisure programs, and brain activity for the elderly also have been conducted in welfare centers and public health centers. However, there are not enough programs that have proven effective in the studies.

So the investigators would like to develop a multi-domain intervention program and investigate applicability and efficacy before a large-scale randomized controlled trial.

Eligibility Criteria:
Inclusion Criteria:

1. Aged 60-79
2. Having at least one among the following dementia risks,

   * hypertension
   * Diabetes Mellitus
   * Dyslipidemia
   * Obesity
   * Abdominal obesity
   * Metabolic syndrome
   * Smoking
   * educational level ≤ 9 years
   * Physical inactivity
   * Social inactivity
3. Independent activities of daily living
4. Mini-Mental State Examination score better than1.5 standard deviations below age and education-adjusted normative means
5. Can read and write Korean
6. Having a reliable informant who could provide investigators with the requested information.
7. Provide written informed consent

Exclusion Criteria:

1. Major psychiatric illness such as major depressive disorders
2. Dementia
3. Substantial cognitive decline
4. Other degenerative disease (e.g., Parkinson's disease)
5. Malignancy within 5 years
6. Cardiac stent or revascularization within 1 year
7. Serious or unstable symptomatic cardiovascular disease
8. Other serious or unstable medical disease such as acute or severe asthma, active gastric ulcer, severe liver disease, or severe renal disease
9. Severe loss of vision, hearing, or communicative disability
10. Any conditions preventing cooperation as judged by the study physician
11. Significant laboratory abnormality that may result in cognitive impairment
12. Unable to participate in exercise program safely
13. Coincident participation in any other intervention trial
Phase III Clinical Study of VC004 in Patients With Localized Advanced/ Metastatic Solid Tumors

This Study is a single arm, open label, multicenter phase III clinical trial to evaluate the safety and efficacy of VC004 in patients with locally advanced/metastatic solid tumors.


Eligibility Criteria:
Inclusion Criteria:

* All subjects or legal representatives are willing and able to sign ICF approved by the ethics committee before starting any screening procedures；
* Male or female, age ≥12 years old;

Exclusion Criteria:

* Patients have undergone major surgery within 4 weeks prior to the first dose or are expected to undergo major surgery during the trial (excluding vascular access establishment procedures, biopsy procedures);
* Adverse reactions caused by previous treatment have not recovered to ≤1 grade (evaluated by the investigator);
* Patients had been treated with a strong CYP3A inhibitor or inducer within 7 days prior to the first administration of the study drug.
Heart Rate Variability Under Propofol and Sevoflurane

Patients were randomized into 2 groups according to the anesthetic, propofol or sevoflurane. Induction and maintenance were standardized, and after the end of surgery, two steady-state recordings were performed at BIS 25 and BIS 55. Bispectral Index and ECG were continuously recorded and cardiac autonomic nervous activity was investigated using spectral analysis of RR Interval variability


Eligibility Criteria:
Inclusion Criteria:

* ASA risk classification 1 or 2,
* scheduled for middle ear surgery, or cardiovascular ANS activity.

Exclusion Criteria:

* preoperative medications that interfere with the autonomic nervous system
* preoperative medications that interfere with the central nervous system
Invasive Group B Streptococcus Disease Burden and Its Antimicrobial Resistance in Malaysia Among Non-pregnant Adults.

Group B Streptococcus (GBS) infection is a potential aetiology of meningitis and septicemia in neonates, pregnant women and non-pregnant adults. Because the GBS disease burden is unknown in Malaysia, it is unlikely to receive much attention. This study aims to determine the prevalence of group B streptococcus isolated from non-pregnant adults, the Incidence, case-fatality ratio, antimicrobial susceptibility patterns, serotyping, genotyping and detection of the GBS virulence and pili genes from six major hospitals in Peninsular Malaysia.

This multicentre, prospective, observational study will be conducted in six major tertiary hospitals in Malaysia among Non-Pregnant Adults. At the same time, a retrospective study will be conducted on the selected hospitals to determine GBS strains and data. GBS isolates will be subjected to phenotyping, serotyping using Multiplex PCR, antimicrobial susceptibility testing and detection of GBS virulence and pilus genes. Seven housekeeping genes will be sequenced internally to perform multi-locus sequence typing (MLST). Findings from the study will contribute to improving clinical practice to diagnose and prevent GBS disease on time. The prudent use of antibiotics will be encouraged by monitoring antimicrobial resistance.

Eligibility Criteria:
Inclusion Criteria:

* Non-pregnant adult patients
* patients with group B streptococcus infection
* The clinical samples isolated from sterile sites (blood, cerebrospinal fluid, internal tissue, pus aspirate, peritoneal dialysis fluid, bone biopsy, skin biopsy and bone marrow).

Exclusion Criteria:

* Repeated group B streptococcus that is isolated from the same patients in the same admission
* Non-sterile site isolates (Urine, Vaginal swab)
Feasibility and Effects of Laughter-imitation Therapy (LIT)

Background: The mental wellbeing of the institutional population has to be promoted, particularly after the serious hit by the pandemic.

Objectives:

1. To develop a LIT intervention to promote mental wellbeing of institutional older adults
2. To explore the feasibility and acceptability of such intervention;
3. To explore the potential effect of the intervention

Design and subject:

A pilot cluster randomized control trial will be conducted. The target population is institutional older adults. About 30 participants will be recruited from 2 nursing homes. The intervention is one-month imitated laughter practice. Each practice session lasts for 3 minutes once a day, giving a total of 21 minutes per week and the waitlist control group will be under usual care for the first 8 weeks. Then, they will start intervention after the 8 week, and receive two additional outcome assessments. A brief one-to-one training will be offered and a trained research assistant (RA1). Further in-person demonstration and return demonstration will be conducted until participant is able to demonstrate the Duchenne smile on their own. RA1 will be on-site for two days in the first week and one day in the second week to support the participants. At the end of the intervention, qualitative feedback will be collected from purposive sample until data saturation.

Instruments: Chinese version including the World Health Organization Five Well-Being Index (WHO-5), 4-item Subjective Happiness Scale (SHS), Geriatric Depression Scale (GDS), Pittsburgh Sleep Quality Index (PSQI), 5-min Montreal Cognitive Assessment, FRAIL scale, Geriatric Adverse Life Events Scale (GALES).

Main outcome measures: Feasibility and acceptability of laughter-imitation therapy (LIT)

Data analysis: Descriptive statistics will be calculated for participants' characteristics, practice frequency, satisfaction, and health outcomes. Linear mixed-effects models will be used to evaluate health outcomes. Content analysis will be conducted for qualitative feedback.

Expected results: The intervention is expected to be feasible and acceptable to institutional older adults as a means for promoting mental wellbeing, and potential beneficial effects will be demonstrated.


Eligibility Criteria:
Inclusion Criteria:

i. aged ≥65 years, ii. living in institutions for ≥6 months and will continue to live there for ≥6 months, iii. no communication problems, iv. cognitively capable (screened by 5-min Montreal Cognitive Assessment (MoCA) \> age-and-education specific cutoff at 7th-percentile).

Exclusion Criteria:

i. facial paralysis or paralysed Zygomaticus major muscle or orbicularis oculi muscle, ii. hearing problem that prevent them from following audio recording, iii. undergoing oxygen therapy that may hinder their practice, iv. those with undiagnosed depression but is detected by screening with Geriatric Depression Scale ≥ 8 (they will be referred to professional service).
Reduction of Pro-Inflammatory Synovial Fluid Biomarkers in Osteoarthritis of the Knee With Alpha-2 Macroglobulin

The purpose of the current study is to assess the ability of alpha-2-macroglobulin treatment to reduce the level of pro-inflammatory synovial fluid biomarkers in patients with osteoarthritis of the knee.

This is a double-blinded rationalized control trial with prospective data collection. The study will collect and analyze the synovial fluid, serum, and urine of patients presenting with knee osteoarthritis in Kellegren-Lawrence grade 2 or 3. It will compare synovial fluid biomarker levels between patients receiving an intra-articular alpha-macroglobulin, intra-articular PR injection and intra-articular corticosteroid serving as a control. Pre-injection pain and function will be assessed. Post-injection pain, function and outcomes will be assessed after six weeks and three months.


Eligibility Criteria:
Inclusion Criteria:

* Patients osteoarthritis classified as Kellegren-Lawrence grade 2 or 3

Exclusion Criteria:

* Mentally impaired (e.g, Alzheimer's subjects, dementia, etc.)
* Younger than 18 years of age
* Greater than 90 years of age
* Patients with underlying inflammatory arthropathies
Investigation of Cardiac Function Following Low-Intensity Ultrasound Intervention

The goal of this clinical trial is to investigate the influence of ultrasound on cardiac functrion.

The main question it aims to answer is:

How will ultrasound affect the cardiac function?

Researchers will： Apply ultrasound to the body and observe cardiac functions.

Participants will:

Receive ultrasound application and physiological signal monitoring.

All procedures conducted in this trial comply with the ethical standards of the relevant national and institutional committees on human experimentation and with the Helsinki Declaration of 1975, as revised in 2008. All procedures were approved by the Research Ethics Committee of ShanghaiTech University (Q2024-004).

The primary outcome is heart rhythm. It will be measured by electrocardiogram. The secondary primary outcome is the incidence of treatment-related adverse events. It will be measured by electrocardiogram and observation.

Eligibility Criteria:
Inclusion Criteria:

* Healthy individuals without significant diseases or chronic conditions.
* Aged between 18 and 65 years.
* Voluntary participation with signed informed consent.
* No history of cardiovascular disease.

Exclusion Criteria:

* Individuals with heart disease or other conditions that may affect cardiac function measurement.
* Individuals with implanted electronic devices such as pacemakers or defibrillators.
* Those on medications that significantly alter heart rate, such as beta-blockers, unless under stable control for a specific period.
* Individuals at risk of severe complications.