cyrilzakka/clinical-trials huggingface dataset:
Effectiveness of Early Intervention in Transfusion Independent Aplastic Anemia: a Retrospective Medical Claims Database Study

This was a retrospective non-interventional cohort study with secondary use of data from the Medical Data Vision (MDV) hospital-based database to evaluate the effectiveness of early drug intervention in preventing transfusion compared to watchful observation among adult transfusion-independent aplastic anemia (AA) patients in Japan.


Eligibility Criteria:
Inclusion Criteria:

* Having at least one confirmed diagnosis of AA within the selection period (1 inpatient or 2 outpatient claims per the International Statistical Classification of Diseases, 10th Revision \[ICD-10\] code, without any suspicion flag).
* Being aged 15 to 90 years at the index date.
* Having at least 3 months of continuous enrolment prior to the index date.

Exclusion Criteria:

* Having a blood transfusion recorded any time before the index date.
* Having anti-thymocyte globulin (ATG) treatment recorded within 3 months after the index date.
* Having at least one prescription record for any of the drug treatments of interest any time before the index date.
* Having a diagnosis of acute myeloid leukemia (AML), chronic myelomonocytic leukemia (CMML) or other leukemia any time before the index date.
* Having an AA diagnosis (without suspicious flag) date earlier than the start of patient's observation in the database.
* Having less than 6 months of continuous follow-up.

Safety Population - Additional Exclusion Criterion:

- Having a diagnosis of hepatotoxicity, kidney dysfunction, hypertension, or diabetes mellitus any time before the index date.
Magnetic Resonance Imaging of Atrial Septal Defects

An atrial septal defect (ASD) is a hole in the heart that can lead to heart failure. Depending on the size and severity of the ASD, They can be treated during a heart catheterization with a special device that can permanently seal the ASD, but knowing the exact size and severity of the ASD is crucial. Newer MRI techniques may provide a better way at diagnosing the size and severity of an ASD. We compared MRI to other standard clinical ways for evaluating an ASD.

Background: Atrial septal defect (ASD) flow can be measured indirectly by velocity-encoded cardiovascular magnetic resonance (veCMR) of the pulmonary artery and aorta (Qp/Qs). Imaging the secundum ASD en face could potentially enable direct flow measurement and, additionally, provide valuable information regarding ASD size, shape, location, and proximity to other structures.

Methods: Patients referred for possible transcatheter ASD closure underwent a comprehensive standard evaluation including transesophageal and/or intracardiac echocardiography (ICE), and invasive oximetry. CMR was performed in parallel and included direct en face veCMR after an optimal double-oblique imaging plane was determined accounting for ASD flow direction and cardiac-cycle interatrial septal motion.

We hypothesized that En face veCMR using an optimized imaging plane can accurately determine ASD flow, size, and morphology, and that it would provide information incremental to comprehensive standard evaluation.

Eligibility Criteria:
Inclusion Criteria:

* Suspected Atrial Septal Defect (ASD) undergoing evaluation for possible transcatheter closure

Exclusion Criteria:

* Contraindications to magnetic resonance imaging
* known sinus venosus or primum defects
Safety Study of ChimeriVax™-JE Vaccine to Prevent Japanese Encephalitis.

The purpose of this study is to assess whether ChimeriVax™ JE vaccine (a new vaccine to be used for vaccination against Japanese encephalitis) is safe and well tolerated when compared to placebo (dummy) vaccination.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent obtained from the subject.
* Aged 18 years or above at screening.
* In good general health
* Subject available for the study duration
* For female subjects (of child bearing potential) a negative pregnancy tests at Screening and Day 0.

Exclusion Criteria:

* A history of vaccination against or infection with JE.
* Known or suspected immunodeficiency, use of immunosuppressive or antineoplastic drugs.
* History of thymoma, thymic surgery (removal) or myasthenia gravis.
* Clinically significant abnormalities on laboratory assessment
* Anaphylaxis or other serious adverse reactions characterised by urticaria or angioedema to foods, Hymenoptera (bee family) stings, or drugs including vaccines).
* Transfusion of blood or treatment with any blood product, including intramuscular or intravenous serum globulin within six months of the Screening Visit or up to Day 30.
* Administration of another vaccine or antiviral within 30 days preceding the Screening visit or up to Day 30.
* Physical examination indicating any clinically significant medical condition.
* Oral temperature \>38°C (100.4°F) or acute illness within 3 days prior to inoculation.
* Intention to travel out of the area for an extended period that may affect the subjects ability to attend clinic visits prior to the study visit up to Day 30.
* Seropositive to hepatitis C virus (HCV) or HIV or positive for Hepatitis B Surface Antigen.
* Lactation or intended pregnancy in female subjects.
* Excessive alcohol consumption, drug abuse, significant psychiatric illness.
* A known or suspected physiological or structural condition that compromises the integrity of the blood-brain barrier (e.g. cerebrovascular disease, multiple sclerosis, trauma, infection, inflammation of the brain or meninges).
* Participation in another clinical study within 30 days of the screening visit for this study.
* Employee of the study site, Sponsor or Clinical Research Organization (CRO) involved with the management of the study.
* Any other reasons, which in the investigator's opinion, makes the subject unsuitable to participate in the study.
Role of Biomarkers in Patients Undergoing Dialysis Treatment

A precise volume status assessment is critical to improve outcome of patients on dialysis. Yet, accurate assessment of fluid status remains a challenge. Currently, this is performed by clinical evaluation and regular weight measurements before and after dialysis, which is not always accurate. Moreover, bioimpedance technology is used in some centers for quantitative assessment of total body water. This approach has been validated for the assessment of volume status in dialysis patients, but requires the acquisition of specific tools and is time consuming. So far, no biomarker has been validated to quantify volume status in dialysis patients. Application of biomarkers might contribute to a better dialysis prescription and therefore to outcome improvement in dialysis. The investigators aim to investigate the role of a novel biomarkers (sCD146) to assess volume status in dialysis patients


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years old
* Patient on dialysis since \> 1 month
* Voluntarily signed informed consent

Exclusion Criteria:

* Pregnant or breastfeeding women and women who plan to get pregnant during study
* Incapability of following the study protocol
* Acute illness
* Hospitalizations in the last week before inclusion
* Cardiac pacemakers or defibrillators
* Limb amputation or other factors precluding a reliable bioimpedance measurement (unreliable bioimpedance measurement)
Parkinson's Research With Inclusion, Diversity and Equity

The purpose of this study is to identify the health and healthcare needs of LGBTQIA+ and non LGBTQIA+ communities living with Parkinson's disease.

Four million LGBTQIA+ adults age 50+ live in the U.S. Very little is known about the needs of the LGBTQIA+ community living with Parkinson's disease (PD). This research will work with the LGBTQIA+ community to learn about the health needs of those living with PD. The researchers will also talk to caregivers about their care experiences, and ask healthcare providers about their work with LGBTQIA+ communities living with PD. LGBTQIA+ adults have more health and care problems. This study will test if LGBTQIA+ adults with PD experience more health and care problems. This study will also see if caregivers have more problems and how providers are caring for the LGBTQIA+ community living with PD. LGBTQIA+ adults living with PD, caregivers and care providers will be asked to fill out a survey. Some caregivers will be asked to participate in an hour interview to learn about their experiences. Surveys and interviews can be done by phone or internet. The study will find ways to improve health and care of LGBTQIA+ people living with PD. The study will share findings so others can help to make care better for the LGBTQIA+ community.

Eligibility Criteria:
Inclusion Criteria:

* Identify as LGBTQIA+ or non-LGBTQIA+
* Aged 18+
* Ability to complete the phone or online survey in English/Spanish
* Diagnosis of Parkinson's disease or a caregiver of a person with Parkinson's disease
* Health care professional that provides care to patients living with Parkinson's disease

Exclusion Criteria:

* Not having a diagnosis of Parkinson's disease
* Not currently or in the past a caregiver of a person with Parkinson's disease
* Not currently providing care to patients with Parkinson's disease
* Inability to complete the survey in English or Spanish
* Inability to provide informed consent
Global Performance Evaluation of the AMS CONTINUUM™ Device

1. To evaluate Device performance in providing mucosa to mucosa apposition to facilitate sustainable vesico-urethral anastomosis during a radical prostatectomy procedure.
2. To assess clinical outcomes of the Device in facilitating the vesico-urethral anastomosis following a radical prostatectomy.

Radical prostatectomy (RP) is the most utilized surgical treatment option for localized prostate cancer due to the multi-focal nature of the disease. RP is most suitable for otherwise healthy men whose cancer is limited to a small area. The RP procedure involves removing the prostate gland, seminal vesicles and nearby lymph nodes. One of the most technically challenging and critical aspects in all of these surgical approaches is reconstruction of the interrupted urinary tract by hand sewing the vesico-urethral anastomosis. This is where the bladder neck is sewn to the urethra after the prostate has been removed.

CONTINUUM™ (study Device) is to be used as part of the RP procedure by facilitating the approximation of the bladder neck and urethral stump. The Device brings together and holds the tissue in place until adequate natural healing of the vesico-urethral anastomosis occurs thereby minimizing extravasation. The Device also provides a conduit for drainage of urine from the bladder out the urethra during tissue healing.

The concept of the CONTINUUM™ device and the feasibility of its operation have been successfully tested in animal and human studies. Pilot clinical studies in the United States (G060095) found that the majority of subjects who received and were discharged with the Device demonstrated a water-tight vesico-urethral anastomosis at the first Device removal visit. Additionally, no unanticipated adverse device effects (UADEs) were reported. The focus of the proposed study is to further verify the performance of the Device in global research centers.

Eligibility Criteria:
Inclusion Criteria:

* All males ≥ 40 years old who are indicated for a radical prostatectomy will be eligible to participate in the study

Exclusion Criteria:

* If contraindicated for surgery
* Inability to understand the study or a history of non-compliance with medical advice
* Unwilling or unable to sign an Informed Consent Form (ICF)
* A history of:

  1. Recurrent urinary tract infections (UTI)
  2. Recurrent stricture disease
* Neurological disease with a history of bladder dysfunction (e.g., Parkinson's disease)
* Uncontrolled insulin-dependent diabetes
* Chemotherapy within the past 6 months
* Non-topical steroid use within the past 6 months
* Allergy to nitinol, nickel, titanium or silicone
Selenium in the Prevention of Cancer

RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development of cancer. Selenium may be effective in preventing cancer. It is not yet known which dose of selenium may be most effective in preventing cancer.

PURPOSE: Randomized pilot study to determine the effectiveness of selenium in preventing cancer in healthy people.

OBJECTIVES: I. Determine whether daily supplementation with selenium significantly reduces total cancer incidence and site-specific cancer incidence in the general population. II. Determine whether this regimen has a beneficial effect on mood.

OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Participants are stratified according to age (60-64 vs 65-69 vs 70-74). Participants are randomized to one of four arms. Arm I: Participants receive oral placebo once daily. Arm II: Participants receive low-dose oral selenium once daily. Arm III: Participants receive moderate-dose oral selenium once daily. Arm IV: Participants receive high-dose oral selenium once daily. Treatment in all arms continues for up to 2 years in the absence of unacceptable side effects or diagnosis of cancer.

PROJECTED ACCRUAL: A total of 510 patients (170 per stratum) will be accrued for this study within 9-12 months.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Healthy men and women No prior diagnosis of cancer except non-melanoma skin cancer

PATIENT CHARACTERISTICS: Age: 60 to 74 Performance status: SWOG 0-1 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: No active liver disease No known abnormal liver function Renal: No active kidney disease No known abnormal kidney function Other: HIV negative No diminished mental capacity that would preclude study

PRIOR CONCURRENT THERAPY: No other concurrent selenium supplements (50 ug/day or more)
Exciflex for Chronic Wound Therapy

Objectives: The study objective is to carry a pilot clinical assessment comparing the exciflex bandage to standard of care (SoC) for ischemic wounds and will involve participants who are Veterans with lower extremity ischemic wounds.

Research Plan: The study will employ a randomized repeated measures design to assess the therapeutic effectiveness of exciflex in clinical use.

Methodology: All participants with chronic ischemic wounds treated at LSCDVAMC will be potentially eligible for the study. Primary target populations will include Veterans with SCI who are inpatients or residents of the on-site Long Term Care Unit and Veterans with diabetes being followed by the Podiatry Service for wound care. In addition to meeting the general inclusion criteria noted above, further exclusion criteria relating to clinical factors include; (1)Age less than 18 years and (2)Pregnancy.

Clinical Significance: Chronic ischemic wounds fail to heal normally and are a major challenge in the long-term care of many Veterans. The exciflex bandage can improve outcomes and lower cost by automatically delivering electrotherapy without disturbing the wound dressing for up to seven days, unless indicated. The overall study goal is to complete pre-market testing and evaluation of the exciflex bandage system.

The study will employ a randomized repeated measures design to assess the therapeutic effectiveness of the exciflex bandage in clinical use. Progressive changes in wound size, indicative of wound healing, will be determined using 3D digital stereophotogrammetry (LifeViz 3D system, Quantificare Inc., San Mateo, CA) together with wound swabs to collect wound bed fluid. The study cohort will comprise Veterans with ischemic wounds.

A parallel-group randomization will be used and participants will be randomly assigned to one of two groups: the experimental or investigation group (Group A) or the control group (Group B). Random allocation software will be used to produce qualified lists for parallel group assignment a priori and ensure that participants are randomized into groups that result in equal sample sizes Each will have a 50% chance of being assigned to either group. Group A will include eight (8) participants using the study device. Group B will include eight (8) participants undergoing standard of care treatment (SoC) with no study device.

Eligibility Criteria:
Inclusion Criteria:

* All participants with chronic ischemic wounds treated at LSCVAMC will be potentially eligible for the study
* Primary target populations will include Veterans with SCI who are inpatients or residents of the on-site Long-Term Care Unit and Veterans with diabetes being followed by the Podiatry Service for wound care

Exclusion Criteria:

In addition to meeting the general inclusion criteria noted above, further exclusion criteria relating to clinical factors include:

* Age less than 18 years.
* Pregnancy
Comparison Between Low Pressure Versus High Pressure Laparoscopic Cholecystectomy

The physiological changes and postoperative pain are directly related with the degree of intra-abdominal pressure kept during the laparoscopy. The present study aims to examine difference between low pressure pneumoperitoneum (8 mm Hg)and High pressure pneumoperitoneum (12 mm Hg)during laparoscopic cholecystectomy in terms of pain, cardio-pulmonary function, arterial blood gas changes etc.


Eligibility Criteria:
Inclusion Criteria:

* symptomatic gall stone disease

Exclusion Criteria:

* pyocele
* gangrene of gall bladder
* history of cholangitis
* simultaneous CBD stones
* gall stone pancreatitis
* who does not give consent if they will be randomized to LPLC
Botulinum A Toxin in the Treatment of Patients With Painful Bladder Syndrome

Previous clinical observations showed that Botulinum A toxin (BoNT/A) has also an antinociceptive effect and can control the neuropathic pain.

In the urologic field, recent in in vitro and in in vivo studies demonstrated that the neurotoxin is able to inhibit the release of several neurotransmitters from the bladder afferent fibers and urothelium. These neurotrasmitters as SP, CGRP, ATP, NGF and Prostaglandins are involved in neurogenic inflammation. Thus, it is reasonable to hypothesize that patients with affected by painful bladder syndrome (PBS) could benefit from BoNT/A intravesically administered.

The aim of the study is to investigate the clinical and urodynamic effects of an intravesical treatment with BoNT/A in patients affected by PBS associated with increased urinary frequency, who are refractory to conventional treatments. This treatment will be compared to bladder over distention, which is considered a conventional therapy.

Patients with refractory PBS will be prospectively enrolled in the study. Baseline evaluation: Clinical evaluation with visual analog scale (VAS) for pain quantification; QoL assessment with a standardized questionnaire, HAM-A and HAM-D scales for the evaluation of anxiety and depression; voiding diary with the recording of diurnal and nocturnal urinary frequency; urodynamic evaluation, 1 month before commencing the study.

Treatment: According to a computerized randomization, patients will receive: A) one single injection of BoNT/A, 100 U diluted in 10 ml normal saline into the bladder, under cystoscopic guidance, under local anesthesia ; or B) one single bladder overdistension under local anesthesia. C) one single injection of placebo (NACL 0.9 % 10 ml) under local anesthesia.

Follow up: clinical evaluation (VAS, HAM-A and HAM-D, QOL assessment, voiding diary) and urodynamics three months after treatment.

Eligibility Criteria:
Inclusion Criteria:

* refractory bladder pain, the urgency-frequency syndrome, and sterile urine

Exclusion Criteria:

* neurological diseases
* pregnancy and concomitant use of aminoglycosides and anticoagulants
The Vallania Study: A Case Control Study for the Development of Multiomics Blood Tests for Cancer Screening

This protocol is a case-control, multicenter, diagnostic study to collect blood samples to support the development of blood-based screening tests for multiple cancers.


Eligibility Criteria:
Key Inclusion Criteria:

* Age at least 30 years
* Able and willing to provide blood samples per protocol
* Able to comprehend and willing to sign and date the informed consent documents
* Participants must meet one of the following:

  * Diagnosed with a single primary cancer that has not yet been treated
  * No evidence or treatment of any cancer for at least 5 years prior to enrollment

Key Exclusion Criteria:

* A medical condition which, in the opinion of the investigator, should preclude enrollment in the study
* Known to be pregnant
* Any therapy for cancer, including surgery, chemotherapy, immunotherapy, and/or radiation therapy in the 5 years preceding enrollment
* Participated or currently participating in a clinical research study in which an experimental medication has been administered in the last 30 days
* Participated in or currently participating in another Freenome clinical study
* For the control cohort: Any previous cancer diagnosis in the 5 years preceding enrollment, or recurrence of the same primary cancer within any timeframe; or concurrent diagnosis of multiple primary cancers within any timeframe
* For the cancer cohorts: Any previous cancer diagnosis in the 5 years preceding enrollment, apart from the current cancer diagnosis; OR recurrence of the same primary cancer within any timeframe; OR concurrent diagnosis of multiple primary cancers within any timeframe
Intra-operative Fraction of Inspired Oxygen and Lung Injury in Coronary Artery Bypass Grafting Surgery

This study is a prospective observer blinded, central randomization controlled, multi-center clinical trial to assess the relationship between intraoperative FiO2 and postoperative pulmonary complications with lung injury.

Hyperoxia is common in cardiac surgery and is easy to prevent by adjusting FiO2. Since there is no prospective study on different FiO2 and postoperative pulmonary complications (PPCs) during cardiac surgery. We hypothesized that hyperoxia during cardiac surgery could lead to higher incidence of lung injury and PPCs than normoxia. The objective of this trial is to compare postoperative PPCs and other outcomes between hyperoxia and normoxia strategy by PaO2/FiO2 in CABG patients.

Eligibility Criteria:
Inclusion Criteria:

* Age from 18 to 75
* BMI from 20 to 39.9
* ASA II/III
* Undergoing isolated selective on-pump CABG through median sternotomy
* Subsequent admission to an intensive care unit (ICU).

Exclusion Criteria:

* with severe chronic obstructive pulmonary disease (COPD)
* Pregnant woman.
* With current acute coronary syndrome (\<1 week)
* Severe anemia (hemoglobin \<10g/L)
* Preoperative supplemental oxygen requirement to maintain arterial O2 of 92%,
* Right to left shunt in heart
* Carotid stenosis defined as \>50% stenosis of either carotid artery,
* Cardiac surgery that requires intraoperative circulatory arrest,
* Current use of dialysis,
* One-lung ventilation during surgery,
* Recent smoking (within 1 month),
* Non-respiratory reason to reintubate or delayed extubation such as bleeding or heart failure,
* Perioperative allogenic transfusion with red blood cell, plasma or platelet