cyrilzakka/clinical-trials huggingface dataset:
The Eosinophils Percentage Predicts In-hospital Major Adverse Cardiac Events in STEMI Patients After PCI

Eosinophils (EOS) in peripheral blood are significantly decreased in ST-segment elevation myocardial infarction (STEMI) and the reduced EOS indicates severe myocardial damage. Whether EOS is a good predictor for in-hospital major adverse cardiac events (MACEs) of patients with ST-segment elevation myocardial infarction remains unknown. The aims of this study was to evaluate prognostic role of EOS for in-hospital MACEs in STEMI patients who have undergone primary percutaneous coronary intervention (PCI)

The investigators retrospectively analyzed the clinical data of 518 patients with STEMI after PCI. MACEs were defined as cardiac arrest, cardiac rapture, malignant arrhythmia and cardiac death. The receiver operating characteristic (ROC) curves were used to demonstrate the prognostic value of EOS% in in-hospital MACEs. All patients were divided into 2 groups according to the best cut-off EOS% value, including reduced EOS% group and control group. Cox regression analyses and KM survival curve were used to calculate the correlated between EOS with in-hospital MACEs.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with STEMI who underwent PCI within 12 hours from symptom onset
2. Patients from whom informed consent has been properly obtained in writing prior to start of the trial.

Exclusion Criteria:

1. Patients with previous myocardial infarction, congenital heart disease
2. Patients with liver disease, and renal failure
3. Patients with immunologic disease, malignant tumors, pregnancy, infection caused by various pathogens, chronic inflammatory disease, trauma.
Safety and Dose Escalation Study of Zinc Supplementation in Critically Ill Children

The purpose of the study is 1) to determine whether administration of intravenous zinc to critically ill children is safe, and 2) to determine an appropriate dose of zinc supplementation.

Our recently published studies in children with septic shock demonstrated that pediatric septic shock is characterized by large scale repression of genes that either directly depend on normal zinc homeostasis or directly participate in zinc homeostasis. Functional validation studies demonstrated that nonsurvivors of pediatric septic shock have abnormally low serum zinc concentrations. A follow-up pilot study in a general population of critically ill children demonstrated that the presence of low plasma zinc concentrations is a prevalent problem in critically ill children. In addition, low plasma zinc concentrations correlate inversely with indices of inflammation and directly with the number of organ failures. These preliminary data, coupled with the expected safety of zinc supplementation, provided the rationale for a double blinded, prospective, placebo-controlled trial of zinc supplementation in critically ill children, with the two primary study endpoints to assess efficacy being highly clinically relevant: reduction of the lymphopenia rate and improvement of glucose homeostasis. Although the proposal was well-received, the primary concern precluding funding of this trial were lack of safety and dosing data for intravenous zinc. We have therefore developed a proposal for a Phase I/II study of safety and pharmacokinetics to address these concerns. It is anticipated that data generated through this proposal will provide the necessary preliminary data to re-submit our application for an interventional efficacy trial of zinc supplementation in critically ill children

Eligibility Criteria:
Inclusion Criteria:

* Admission to pediatric intensive care unit
* Age between 1 month and 10 years
* Pediatric Risk of Mortality III score \> 5, OR presence of at least 1 new organ failure
* Anticipated pediatric intensive care unit length of stay \> 3 days
* Ability of parent or legal guardian to provide informed consent

Exclusion Criteria:

* Known zinc deficiency
* Pre-existing bone marrow failure
* New or existing diagnosis of diabetes mellitus
* Limitation of care orders in place
* New diagnosis of brain injury, encephalopathy
* Clinical contraindication for zinc supplementation
Effectiveness of GO for Transitional Housing Residents

The goal of this pre-post study is to enhance the health and wellness of the residents in the Concordia Tsat Sing Kong Transitional Housing Estate. This study aims to evaluate the effectiveness of the Green Oasis (GO) wellness program in:

1. Increase health awareness and engaging in health promoting activities, including more physical activities/walking, gardening.
2. Enhance happiness and quality of life.

Participants will:

* complete physical exercises, gardening, and interact with the GO website
* receive health talks


Eligibility Criteria:
Inclusion Criteria:

* Aged 10 or above.
* Scored \>6 in the Abbreviated Mental Test; a cut-off point of 6 is valid in differentiating between normal and abnormal cognitive functions for geriatric clients.
* Can understand Cantonese.
* Able to take part in light exercise and stretching.
* Have access to smartphone and internet.

Exclusion Criteria:

* Have a serious organic disease or malignant tumor.
* Have a mental disorder diagnosed by neurologists or psychiatrists.
* Experienced drug addiction
Using Laser Spatiotemporal Photoplethysmogram and Computational Method for Management of Chronic Disorders.

This investigational study is carried out to find out if a smartwatch monitor worn on the wrist that acts like a blood pressure monitor, will be able to replace the traditional blood pressure measurements using the traditional cuff that is wrapped around your arm.

NHC inpatients (Group A) Patients will be required to put on the LSPPG wearable sensor to take measurement once a day, starting from the day of recruitment till day of discharge. 3 ECG electrodes with cable linking to the LSPPG sensor wearable will also be attached on the chest. This helps to capture ECG rhythm at the same time. Study team member will assist the patient to take daily measurement.

NHC Outpatients scheduled for 24-Hour ABP monitoring (Group B) Patients will wear the LSPPG wearable sensor whilst wearing the 24-hour ambulatory blood pressure monitor. 3 ECG electrodes with cable linking to the LSPPG sensor wearable will also be attached on the chest. This helps to capture ECG rhythm at the same time. Readings will be obtained on an hourly basis during the duration of wearing the ambulatory blood pressure machine (clinical grade device).

Eligibility Criteria:
Inclusion Criteria:

* Above 21 years of age
* Sufficient language skills in English, Chinese, Malay or Tamil
* Provided informed consent

Exclusion Criteria:

* Skin sensitivity to adhesives
Artificial Intelligence 3D Augmented Reality Robot-Assisted-Radical- Prostatectomy v.s. no3D Intervention

This is a prospective randomized multicenter study aimed at comparing 3D AI-AR-RARP vs. no 3D, verifying the impact of this new technology on oncological and functional outcomes after the procedure.

Considering that prostate cancer lesions are not identifiable during surgery, except in the case of extensive and advanced tumors, the surgeon does not have a real-time perception of the location of the tumor. The absence of clear spatial visualization can therefore lead to a positive surgical margin, particularly in tumors in the T3 stage (invasion of the prostatic capsule or seminal vesicles).

Our hypothesis is that with the help of AI 3D AR during surgery, positive surgical margins can be avoided, or at least reduced, while preserving the neurovascular bundles, with a consequent improvement not only in postoperative functional outcomes (continence and potency), but also oncological ones (less biochemical disease recovery (BCR), less need for salvage radiotherapy, lower risk of metastasis).

Eligibility Criteria:
Inclusion Criteria:

1. Signature of the written informed consent and consent to the use of personal data
2. Age \> 40 years and male sex
3. Pre-operative MRI performed according to ESUR recommendations and reporting in accordance with PiRads V.2
4. Disease with evidence of bulging or radiological T3 on pre-operative MRI
5. Histological diagnosis of acinar type prostate cancer in the area highlighted on MRI
6. Absence of bulky (\>3 cm), bony or visceral retroperitoneal or pelvic lymph node metastatic lesions
7. Patients eligible for radical prostatectomy + pelvic lymphadenectomy
8. ECOG PS 0-1
9. Life expectancy ≥ 5 years
10. Patients motivated to preserve erection and with pre-operative sexual activity with IIEF \>17
11. Availability of the patient's pre-operative clinical data
12. Patients must be available to carry out the visits foreseen in the follow-up of the protocol and consent to data collection

Exclusion Criteria:

1. Special histotypes of prostate cancer
2. Patients with PSA \> 100 ng/ml at diagnosis
3. Inability to perform MRI (pacemaker wearers, claustrophobia...) or MRI of inadequate quality to obtain the HA3DTM 3D reconstruction
4. Concomitant treatment with other antineoplastic drugs including investigational endocrine therapies
5. Serious uncontrolled concomitant medical condition or disease including active, uncontrolled infections
6. Patients with dementia or psychiatric illness that limit compliance with study requirements or that may prevent understanding and/or signing informed consent.
Autologous Fat in Peripheral Nerve Injury

The aim of this study is to assess the efficacy of autologous fat graft in enhancing peripheral nerve regeneration. The investigators hypothesize that fat grafting will allow for faster and greater recovery of motor and sensory function following surgical repair of injured peripheral nerves.

Traumatic injuries to peripheral nerves are a frequent finding after hand trauma. High morbidity after nerve injuries mainly affects the younger and working population, with consequent decrease in life quality and productivity .

Even in direct nerve repair and microsurgical nerve coaptation, regeneration is often suboptimal with incomplete target reinnervation. Suboptimal outcome is attributed to axonal degeneration, fibrotic scar formation, and neuromas at the site of injury.

The use of adipose tissue has become very popular in tissue engineering and reconstructive surgery in recent years. It is proposed as a "regenerative tool" for various tissues, including peripheral nerves, because it offers an effective and minimally invasive procedure for obtaining stem cells.

Unprocessed fat grafting can provide a simple approach to improve peripheral nerve regeneration by means of neoangiogenesis \& inflammatory response modulation. Furthermore, it serves as a good protective barrier in peripheral nerve surgery, reducing fibrosis and adhesions.

A recent study advocated by Tuncel et al, concluded that combined use of autologous fat graft with surgical repair methods induced significantly better regeneration in rats \[3\]. In another study by Kilic et al, using adipose tissue flap in a crush injury model in rats was found to be superior to other groups in myelin thickness, nerve fiber density, axon count, and functional recovery at 4 weeks. They concluded that fat tissue seems to promote nerve regeneration because of its stem cell content.

To our knowledge, no prior studies have examined the use of fat graft in peripheral nerve repair in humans. So, the investigators proposed this clinical study to evaluate the outcomes of primary nerve repair combined with autologous fat graft in peripheral nerve injuries.

Eligibility Criteria:
Inclusion Criteria:

- Acute median or ulnar nerve lacerations below elbow

Exclusion Criteria:

* Old Nerve lacerations \> 48 hours
* Nerve gap which requires nerve grafting
* Psychosocial issues that would limit participation and compliance
A Study to Investigate the Safety and Effectiveness of Different Doses of Sprifermin in Participants With Osteoarthritis of the Knee

This was a multicenter, randomized, double-blind, placebo-controlled, parallel-group Phase 2 trial of Sprifermin administered intra-articularly in participants with primary osteoarthritis of the knee and Kellgren-Lawrence Grade 2 or 3. The trial was intended to investigate the efficacy and safety of different intra articular dosages of Sprifermin in these individuals.

Participants were equally randomized to either one of 4 treatment arms or a placebo arm. The trial consists of a Screening period lasting up to 42 days, a two-year double-blind placebo-controlled (DBPC) treatment phase, which begins at randomization (Week 0) and ends at Year 2, and a 3-year extended follow-up phase.

Eligibility Criteria:
Inclusion Criteria:

* Age from 40 to 85 years; of either sex
* Primary femorotibial osteoarthritis according to American College of Rheumatology (ACR) clinical and radiographic criteria , and meeting protocol-specified X-ray criteria in the target knee at screening
* Pain score in the target knee and/or the need for regular symptomatic treatment of knee pain with paracetamol (acetaminophen), systemic non-steroidal anti-inflammatory drugs (NSAIDs) including cyclooxygenase (COX)-2 selective inhibitors (coxibs), or tramadol on most days in the previous month (that is, more than half of the days in the previous month)
* A history of pain due to Osteoarthritis in the target knee for at least 6 months
* A protocol-specified pain score for the target knee in response to Question 1 of the WOMAC pain index ("how much pain have you had \[in the target knee, over the past 48 hours\] when walking on a flat surface?") after washout of at least 5 half-lives of analgesic medication(s): acetaminophen, topical or oral NSAIDS, coxibs, opioids, and/or tramadol
* Women of childbearing potential must use a form of contraception with a failure rate of less than 1 percent per year throughout the trial

Exclusion Criteria:

* Malalignment of greater than 5 degrees in the femorotibial axis of the target knee
* Clinical signs of inflammation (redness) in the target knee
* Intra-articular administration of corticosteroids or hyaluronic acid into either knee within 6 months before Screening
* Planned knee surgery (affecting either the target or the contralateral knee) within the next two years
* Concomitant conditions or treatments deemed to be incompatible with trial participation
* Any contraindication to MRI according to MRI guidelines, including the inability to undergo a knee MRI exam because of inability to fit in the scanner or knee coil
* Pregnancy or breastfeeding
* Participation in another clinical trial within the 30 days (or 5 half-lives of the investigated compound, whichever is longer) before screening
* Legal incapacity or limited legal capacity
MTX Discontinuation and Vaccine Response

To investigate whether a short term discontinuation of methotrexate (MTX) will improve the vaccination efficacy to seasonal influenza vaccination without deteriorating RA disease activity in a randomized clinical trial.

Rheumatoid arthritis (RA) is a chronic systemic inflammatory disease that affects the joints as the main target of the inflammation. Patients with RA require chronic treatment with disease modifying anti-rheumatic drugs (DMARDs) including methotrexate (MTX), which constitutes the mainstay of treatment.

Underlying immune dysfunction and the additional immune suppression associated with treatment render patients with RA more susceptible to infection. Thus, vaccination against preventable diseases including influenza, pneumococcal pneumonia and hepatitis B is recommended for all RA patients who are subject to treatment with immunesupprssive drugs, unless there is a contraindication to the use of vaccination. However, low dose of glucocorticoids, conventional DMARDs and biological DMARDs including tumor necrosis factor inhibitors have been reported to substantially decrease vaccine response (4); MTX has been reported to be associated with a decreased response to seasonal influenza vaccination by up to 15%.

To optimize a vaccine response, vaccination should be administrated before the treatment with immunesuppressive medications is initiated. However, most patients with RA are already on stable dose of DMARDs at the time of when vaccinations, especially vaccine against seasonal influenza that needs annual administration, are considered. Alternatively, temporarily discontinuation of DMARDs might restore normal immune response to and so improve the efficacy of vaccination.

Although a short term discontinuation of DMARDs during perioperative period has not been associated with increased disease activity the longer discontinuation of DMARDs might lead to a significant aggravation of RA disease activity. To optimize the vaccine response, a short term discontinuation of DMARDs could be considered if this approach proves to be safe and effective.

Eligibility Criteria:
Inclusion Criteria:

* Males or females \> 18 years at time of consent
* Have a diagnosis of RA per ACR criteria
* Must understand and voluntarily sign an informed consent form including writing consent for data protection
* Stable doses of methotrexate over the preceding 6 weeks

Exclusion Criteria:

* Pregnant or lactating females
* Previous anaphylactic response to vaccine components or to egg.
* Acute infection with T \>38°C at the time of vaccination
* History of Guillain-Barre syndrome or demyelinating syndromes
* Previous vaccination with any live vaccine 4 weeks before or any inactivated vaccine 2 weeks before the study
* Blood transfusion within 6 months
* Active rheumatoid arthritis necessitating a recent change in the drug regimen
* Any other rheumatic disease such as systemic lupus erythematosus, mixed connective tissue disease, dermatomyositis/polymyositis, and vasculitis except for secondary Sjogren's disease
Implantable Loop Recorder Versus Conventional Ambulatory Monitoring in Detecting Atrial Fibrillation After Pulmonary Vein Isolation

The primary aim of the study is to assess the efficacy of continuous rhythm monitoring with an implantable loop recorder (ILR) compared to conventional ambulatory electrocardiography in detecting episodes of atrial fibrillation after pulmonary vein isolation (PVI). The secondary aim is to assess the efficacy of PVI during a two years follow-up and to assess the reliability of the implantable loop recorder in detecting atrial fibrillation.

50 patients will be enrolled into the study. After enrollment an implantable loop recorder will be implanted at least 6 weeks before scheduled PVI. All patients will be followed for 24 months after PVI. During the follow-up period a 72-hours ambulatory electrocardiographic monitoring will be performed at 1, 6, 12, 18, and 24 months. Transthoracic echocardiography will be performed at enrollment, 3, 12, and 24 months after PVI. Moreover, quality of life will be assessed at baseline, and 6 and 12 months after PVI.


Eligibility Criteria:
Inclusion Criteria:

* Age =\> 30 to =\< 70 years
* Documentation of paroxysmal atrial fibrillation
* Documentation of persistent atrial fibrillation of \< 3 months duration termination either spontaneously or by DC cardioversion
* Scheduled pulmonary vein isolation
* Treatment with at least one class IC or class III antiarrhythmic drug tried

Exclusion Criteria:

* Atrial fibrillation episodes \> 3 months or permanent atrial fibrillation
* No indication for pulmonary vein isolation
* Contraindications for anticoagulation treatment
* No informed consent
Prostatectomies Using Einstein Vision® 3D

The aim of the study is collecting clinical data on the learning curve of different surgeons using the EinsteinVision® 3D visualization system in laparoscopic radical prostatectomies.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing planned radical prostatectomy prostatectomy because of histologically proven prostate cancer using EinsteinVision®
* Written informed consent
* Age ≥ 18 years

Exclusion Criteria:

* Previous TURP (= transurethral resection of the prostate)
* Previous operations on the sigmoid colon or rectum (e.g. because of carcinoma, perforation, diverticulum)
* BMI \> 35 kg/m²
* Participation in another clinical study
* Representation by a legal guardian or under involuntary commitment
Expression of Inflammatory Proteins in Pancreatic Cancer

The purpose of this trial is to investigate the expression of different inflammatory proteins in cancer and normal pancreatic tissue.

Purpose: to investigate the expression of different inflammatory proteins in cancer and normal pancreatic tissue

* Trial with surgical intervention

Eligibility Criteria:
Inclusion criteria:

* Patients with pancreatic cancer or chronic pancreatitis

Exclusion criteria:

* Patients with alpha 1-antitrypsin deficiency
Trial of Mifepristone in Combat Veterans With Posttraumatic Stress Disorder

The investigators propose to conduct a randomized double-blind, parallel-group, placebo-controlled trial of mifepristone in veterans with military-related posttraumatic stress disorder (PTSD). This study will examine the clinical, neuropsychological, and neuroendocrine effects of short-term treatment of mifepristone (600 mg/day for one week) to determine if this treatment is efficacious in improving PTSD symptoms, cognitive functioning, or other related clinical measures. Additionally, the investigators will observe whether baseline neuroendocrine activity, or other clinical or neuropsychological factors predict the response to mifepristone, and whether mifepristone-induced changes in neuroendocrine activity are associated with treatment outcome.


Eligibility Criteria:
Inclusion Criteria:

* Subject is a male U.S. veteran
* Subject was exposed to combat or another criterion A traumatic event during military service
* Subject meets diagnostic criteria for chronic PTSD

Exclusion Criteria:

* Veteran has a history of adrenal insufficiency or a plasma cortisol level less than 5 mcg/dl at screening
* Veteran has a moderate-severe traumatic brain injury, a history of a stroke, or another neurological illness or injury likely to impact cognitive functioning
* Veteran has diabetes mellitus, an endocrinopathy, or another major medical illness.
* Veteran is taking oral corticosteroids
* Veteran has a lifetime diagnosis of schizophrenia, schizoaffective disorder, or bipolar disorder
* Veteran is currently suicidal or otherwise is in need of urgent clinical care
* Veteran is currently receiving specialized trauma-focused psychotherapy (i.e., prolonged exposure, cognitive processing therapy or eye movement and desensitization reprocessing).
* Veteran is not willing to use effective means of birth control during the study or for 90 days after taking study medication
* Veteran has history of allergic reaction to mifepristone