cyrilzakka/clinical-trials huggingface dataset:
MIRACLE of LIFE Study

The goal of this observational study is to develop and validate cell-free RNA-based biomarkers for predicting a variety of adverse pregnancy outcomes in a pregnant person population. The main question it aims to answer are:

1. Can cell-free RNA-based biomarkers predict which pregnant people are at greatest risk of developing adverse pregnancy outcomes (e.g., preterm birth, preeclampsia)?
2. What is the performance of such biomarkers when predicting an adverse pregnancy outcome (e.g., sensitivity, specificity, PPV, NPV, TPR)?

This is a multi-center, prospective, observational cohort study, that involves the collection of blood samples from pregnant people during their second trimester of pregnancy. Maternal plasma is isolated from blood samples and subjected to transcriptome and other multi-omic analyses. In conjunction with blood sample collection, extensive clinical data are collected about the pregnancy including any pregnancy complications (e.g., preterm birth, preeclampsia) that may have arisen during pregnancy. Biological markers and clinical data are combined to develop and validate Mirvie's investigational predictive test.

Eligibility Criteria:
Inclusion Criteria:

1. Subject is willing and able to provide written informed consent.
2. Subject is willing and able to provide up to 40 mL of blood via venipuncture and comply with all other study procedures.
3. Subject is a pregnant female before 22 weeks of gestation
4. Subject is at least 18 years of age

Exclusion Criteria:

1. Estimated due date (EDD) via 1st or 2nd ultrasound, date of last menstrual period (LMP), or in-vitro fertilization (IVF) implantation date is not available
2. Subject is pregnant with multifetal gestation (e.g., twins)
3. Subject is planning to deliver via home birth
Efficacy Study of Acetazolamide Versus Diazepam in Continuous Spike and Wave/Landau-Kleffner Syndrome

The purpose of this study is to compare the effectiveness of the medications acetazolamide and diazepam in the treatment of continuous spike wave in sleep (CSWS) and Landau-Kleffner syndrome (LKS).


Eligibility Criteria:
Inclusion Criteria:

* ESES and clinical CSWS/LKS defined by all of the following:
* SWI ≥50% during first hour of sleep
* Bilateral synchrony of discharges during sleep
* Clinical evidence of behavior and/or academic regression
* Daytime SWI ≤20%

Exclusion Criteria:

* Previous treatment with benzodiazepine or acetazolamide for Electrical Status Epilepticus in Sleep (ESES)
* Current treatment with carbamazepine, phenytoin, oxcarbazepine, phenobarbital, vigabatrin or lamotrigine
* Antiepileptic medication changes over the month prior to enrollment
* Epileptic encephalopathy other than CSWS/LKS
* Prior serious adverse reaction to benzodiazepines or acetazolamide
* Sulfa allergy
* Progressive underlying neurologic condition
* Frequent seizures that would prevent the patient from maintaining a stable dose of medications
* Female patient that has begun menses or is pregnant
An Efficacy and Safety Study of SRM003 in the Treatment of Subjects Undergoing Placement of an Arteriovenous Graft to Facilitate Hemodialysis Access

A study to evaluate the efficacy of SRM003 treatment versus participating sites' standard practice treatment in extending the duration of primary patency after arteriovenous graft surgery in subjects with end-stage renal disease.

It is hypothesized that when placed outside the blood vessel, the seeded SRM003 gelatin matrix containing endothelial cells can provide a continuous supply of multiple growth regulatory compounds to the underlying cells within the blood vessel, while being protected from the effects of blood flow in the vessel(s) or complications resulting from being in direct contact with the point of injury.


Eligibility Criteria:
Inclusion Criteria:

1. Subject must be 18 years of age or older at the time of signing and dating informed consent (no upper age limit), can be male or female.
2. Subject who is of child bearing potential must agree to use adequate contraception for 6 months after randomization.
3. Subject must be currently undergoing hemodialysis or anticipating the start of hemodialysis and must require a new permanent prosthetic expanded polytetrafluoroethylene AVG placed in the upper extremity.
4. Subject must have a life expectancy of at least 78 weeks after randomization.
5. Subject must be able to understand and be willing to complete all study requirements.

Exclusion Criteria:

1. Subject is currently on an active organ transplant list from a deceased donor or is undergoing assessment and expects to be placed on the active organ or bone marrow transplant list within the next 78 weeks from surgery, or expects to receive a living donor organ or bone marrow within the next 78 weeks and is unwilling to change transplant list status to "hold" for 3 months after randomization.
2. Subject has had more than 3 access placement surgeries (defined as a new access, not a revision) in the target limb.
3. Subject has medical conditions and diseases that may cause non-compliance with the protocol
4. Subject has a known allergy to bovine/porcine products or collagen/gelatin products.
5. Subject has a history of intravenous drug use within 6 months prior to screening
6. Subject is morbidly obese, defined as having a body mass index \>40.
7. Pregnant or nursing woman, or plans to become pregnant during the study.
Duration of Untreated Psychosis (DUP) and Pathways to Care in Nordland

During the 1990s, evidence began to emerge of the long duration of untreated illness prior to receiving treatment for patients with psychotic disorders. Studies across the world on first episode psychosis have consistently found an average of 1 - 2 years between the onset of psychotic symptoms and the start of treatment. Lengthy treatment delay has immediate implications such as unnecessary distress for patients and families, and may also compromise potential recovery when treatment is initiated.By understanding how and why substantial delays occur the investigators may be able to better design interventions to facilitate better earlier treatment. The components of DUP can be conceptualised as comprising 3 distinct intervals: help-seeking delay, referral delay and delay in mental health services. In this study the primary aim is to establish the level of DUP in nordland, and explore the components of this variable. Help-seeking delay will be investigated by interviewing patients presenting at the central mental health hospital in Nordland about their psychosis onset and pathways to care. Referral delay will be investigated by a questionnaire about the referral pratices among GPs in Nordland. Delays in mental health services will be investigated by focus group interviews with leaders and professionals at the 7 community mental health centers in Nordland. This knowledge is believed to be crucial for developing services that can reduce DUP and give this patient population earlier access to adequate treatment.


Eligibility Criteria:
Inclusion Criteria:

* Any patient presenting with a possible psychotic illness (including schizophrenia, affective psychosis and drug-related psychosis, but excluding organic psychosis).
* Understands and speaks norwegian

Exclusion Criteria:

* Severe learning disability
Clinical Progression of Mild to Moderate Idiopathic Pulmonary Fibrosis (IPF) Under a Therapy With Esbriet® (Pirfenidone)

The purpose of the study was to assess the clinical outcome of patients with a mild to moderate IPF after a one-year therapy with Esbriet® (Pirfenidone).


Eligibility Criteria:
Inclusion Criteria:

Adult patients with confident diagnosis of mild to moderate IPF, who had previously not yet been treated with Pirfenidone

Exclusion Criteria:

Hypersensitivity to the active substance or one of the other excipients of Pirfenidone Concomitant use of Fluvoxamin Severe hepatic impairment or end stage liver disease Severe renal impairment (Creatinine-Clearance \<30 ml/min) or end stage renal disease requiring dialysis Simultaneous participation in interventional studies Previously treated with Pirfenidone for longer than 30 days
Evaluate the Efficiency Impact of Conducting Active Temperature Management During Cardiac Cryoablation Procedures

Left atrial catheter ablation including pulmonary vein isolation is a standard therapy in the management of symptomatic atrial fibrillation; however thermal esophageal injury is a known potential consequence of this procedure. Delivery of radiofrequency (RF) energy necessary to perform left atrial ablation has the potential to cause injury to the nearby esophagus including ulceration, hematoma, spasm, esophageal motility disorders, and, in the most extreme case, atrial-esophageal fistula.Esophageal mucosal lesions are the likely precursor to AEF, and esophageal mucosal lesions have been detected on post-ablation endoscopy after pulmonary vein isolation with an incidence ranging from 3% to 60%.

Active esophageal cooling during RF ablation as a means of esophageal injury prevention has been investigated through mathematical models, pre-clinical studies, and in clinical trials. Existing data support the efficacy of this approach, but the practice has not been widely adopted due to lack of a commercially available device.

The aim of this study is to evaluate the impact on procedural efficiency of ablation procedures performed using esophageal heat transfer to warm the esophagus during left atrial cryoablation.

This study is a prospective, pilot study using the Attune Medical ensoETM esophageal heat transfer device to actively warm the esophagus during cryoablation procedures. This design is appropriate to gather the data needed regarding overall procedural time, compare this to historical controls, and estimate a sample size for a larger study powered for statistical significance.

Once patient consent is obtained, the subject will undergo preparation and anesthesia procedures following standard practice. Once the patient is intubated, the esophageal heat transfer device will be placed into the esophagus according to the IFU. The device will remain in place until the ablation procedure is completed and will be removed before extubation. Left atrial cryoablation using the standard approach will be performed with the ensoETM set at a temperature of 42 degrees C.

All patients will be followed up in total for 6 weeks (Long Term FU visit) after the procedure to document any clinical complication related to thermal esophageal injuries if applicable.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (age over 18 years).
* Undergoing cryoablation for the treatment of atrial fibrillation, including pulmonary vein isolation.
* Patients must be able to understand and critically review the informed consent form.
* Subjects must understand and agree to study requirements and sign a written informed consent.

Exclusion Criteria:

* Patients who are unable to provide informed consent.
* Significant co-morbidities that preclude standard ablation procedure.
* Patients with \<40 kg of body mass.
* Patients with relevant esophageal pathology (e.g. esophageal cancer).
Long Term Impact of Pediatric Acute Renal Injury in Severe Sepsis

Sepsis is the most common cause of childhood death worldwide. Millions of children survive, but are left with impaired health. Sepsis-related Acute Kidney Injury (sAKI) is increasingly recognized as a significant factor associated with long-term mortality among different patient populations. Renal dysfunction and subsequent chronic kidney disease is implicated in the development of hypertension and cardiovascular disease. The investigators overall hypothesis is that, in the pediatric population, sepsis-related AKI will have unrecognized, long-term consequences with regard to kidney function, endothelial function, blood pressure control, and overall health.

This will be a three-arm cross-sectional control-cohort outpatient evaluation. Subjects with sAKI and a random selection of non-sAKI subjects who agree to participate in another study of quality of life survey will be asked to participate in the outpatient study. Subjects will be asked to come in to the Clinical Research Center for 24-hour monitoring and participate in the outpatient study where urinary and serum studies to measure glomerular filtration rate, renal plasma flow followed by blood pressure monitoring, peripheral arterial and applanation tonometry.

Eligibility Criteria:
Inclusion Criteria:

For non-acute kidney injury (AKI) sepsis patients:

1. Hospitalization with a diagnosis of sepsis from 1998-2014
2. Failure to meet pediatric Risk Injury Failure Loss End stage (pRIFLE) criteria for AKI during incident admission.
3. Participation in cognitive survey study with completion of survey

For sepsis related AKI patients:

1. Hospitalization with a diagnosis of sepsis from 1998-2014
2. Need for renal replacement therapy (RRT)
3. Severe AKI as defined by the pRIFLE criteria (estimated CrCl (eCrCl) decrease by 50%, eCrCl \<60 ml/min/1.73 m2, or a urine output \<0.5 ml/kg/h for 24 h or anuric for 12 h) during the sepsis admission
4. Participation in cognitive survey study with completion of survey

For healthy control patients:

1. Identified from the neurology service who are scheduled for MRI with gadolinium as part of their clinical care

Exclusion Criteria:

For all patients:

1. Known pre-existing chronic kidney disease (CKD) as defined by history of kidney transplant or long-term dialysis
2. Age greater than 18 years at the time of sepsis admission
3. AKI from primary kidney disease including acute glomerulonephritis and obstructive uropathy
4. Pregnancy at the time of enrollment
5. Age younger than 5, between the ages of 12 to 17, or over the age of 24 at the time of enrollment.

For healthy control patients:

1. Chronic kidney injury (CKD)
2. History of acute kidney injury
3. History of any chronic illnesses (e.g. cancer)
Bridging Recovery Allies in Virtual Environments

The Bridging Recovery Allies in Virtual Environments (BRAVE) study aims to evaluate the acceptability and feasibility of implementing a virtual environment (VE) social support group for social communication training among adults with traumatic brain injury (TBI).


Eligibility Criteria:
Inclusion Criteria:

* subjects with a traumatic brain injury
* between the age of 18 and 80
* living in the community
* able to read and speak English,
* are more than 1-year post-injury
* are accessible by phone,
* report independent computer usage over the last 6 months
* have access to a computer meeting minimum specifications for the Learning in Virtual Environments (LIVE) platform (requires Windows)
* have broadband Internet connection,
* achieve a Galveston Orientation Assessment Test (GOAT) score \>75 to ensure appropriate levels of cognition for the study
* and score \>93.8 on the Western Battery Aphasia-Revised (WAB-R) scale to indicate sufficient communicative abilities to participate in a social support group and exit interview group.
* able to understand and independently consent for the study and provide written consent prior to enrollment in the study

Exclusion Criteria:

- verbal communication impairments will be excluded as measured by the WAB-R, as this study intends to focus on persons with social communication deficits rather than verbal deficits.
Efficacy and Safety of Dexmedetomidine in the Analgesic Prophylaxis , in Patients Undergoing Cardiovascular Surgery

Acute pain is one of the complications after cardiothoracic surgeries . It can delay patients´recovery and may increase patients´morbity and mortality. This study intends to evaluate Dexmedetomidine, a highly selective α- 2 receptor agonist, that is currently applied safely and efficiently in intraoperative cardiac surgery. It has analgesic, sedative, anxiolytic and sympatholytic properties, without respiratory- depressant effect. The aim of this study is to investigate whether the intraoperative use of dexmedetomidine is better than the standard analgesia used in the intraoperative period to reduce pain and the consequences of it.

This project is a prospective, double-blinded and randomized clinical trial. Eligible participants are assigned in a 1:1 ratio to either the intervention group (Group Dexmedetomidine) or control group (Group Saline 0,9%), after written informed consent to be obtained. The patients will undergo elective cardiac surgery, with extracorporeal circulation.

In the operating room, patients will be monitored for pulse oximetry, invasive blood pressure, electrocardiograms, capnography, central venous pressure and nasopharyngeal temperature probe. Induction of anesthesia is performed with intravenous midazolam, fentanyl, etomidate and neuromuscular blocking agent. Anesthesia is maintained with sevoflurane. Dexmedetomidine, at the rate of 0,3μg/ kg/h, or placebo will be infused from the initiation of the anesthesia up to the end of the procedure, except during the cardiopulmonary by-pass. Placebo is a 0,9% saline. The follow up of the assessment of the groups will extend to the postoperative ICU, where data will be collected, during the first 24 hours after surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients at least 18 years old and who are undergoing cardiac procedures (coronary artery bypass, valve replacement or combined procedure), with cardiopulmonary by- pass.

Exclusion Criteria:

* Congenital heart disease
* Infective endocarditis
* Acute myocardial infarction (\<two weeks)
* Pregnancy
* Cancer
* Left ventricle ejection fraction \< 40%
* Cardiogenic shock
* Emergent procedure
* Use of vasopressor and/or inotrope, in the preoperative
* Liver disfunction
* Renal replacement therapy
* Nephrectomy
* Previous renal transplantation
* Patients who are participating in another clinical research
Usability Study of the FemPulse System

The objective of the study is to demonstrate that the FemPulse System can be used as indicated in the Instructions for Use (IFU), as applicable.


Eligibility Criteria:
Key Inclusion Criteria:

* Females, defined as a person with a uterus and cervix, ≥21 years old, with a diagnosis of OAB and symptoms for more than 6 months, as confirmed by a physician
* Able to read, comprehend, and reliably provide informed consent and study-related information.
* Willing and able to comply with study required procedures and visits (e.g., maintaining consistent medication use, fluid intake, diary completion).
* Has adequate cognitive and manual capabilities to operate the FemPulse System and other components (e.g., mobile app) as assessed by the investigator.

Key Exclusion Criteria:

* Currently pregnant, was pregnant in the past 12 months or intending to conceive during the study period.
* Plans to begin other OAB therapies or otherwise change their existing therapy regimen during the study period.
* Not an appropriate study candidate as determined by investigator.
Assessing AlloSure Dd-cfDNA Monitoring Insights of Renal Allografts With Longitudinal Surveillance

Prospective Observational Multicenter Cohort. External validation of donor derived cell free DNA in Renal Transplantation. Assessing performance of dd-cfDNA as a surveillance tool and its association with clinical outcomes. Outcomes include formation of de-novo DSA, eGFR decline, performance of AlloSure dd-cfDNA in Allograft rejection.


Eligibility Criteria:
Inclusion Criteria:

* Renal transplant patients
The Effect of Topical Application of Tranexamic Acid in Total Hip Arthroplasty Through the Direct Anterior Approach

The effects of topical application of 3g tranexamic acid for 2 hours prior to opening of the suction drain following a total hip replacement


Eligibility Criteria:
Inclusion Criteria:

* patients who will receive a unilateral total hip arthroplasty

Exclusion Criteria:

* coagulopathy
* allergy to tranexamic acid
* preoperative anemia (a hemoglobin value of \< 11g/dL in females and \< 12g/dL in males)
* fibrinolytic disorders
* a history of arterial or venous thromboembolic disease
* pregnancy
* breastfeeding
* major comorbidities
Multicenter Cohort Study of Invasive Fungal Filamentous Fungal Infections in Liver Transplant Patients

Invasive filamentous fungal infections (aspergillosis, scedosporiosis, mucormycosis, fusarium wilt) are frequent and serious in immunocompromised individuals and especially in organ transplant patients. There is little recent data in liver transplantation, especially on the incidence and risk factors of fungal infections


Eligibility Criteria:
Inclusion Criteria

* Age: from birth
* Subject with a liver transplant in one of the centers participating in the study
* Invasive fungal infection with filamentous fungus between 2007-2021
* Proven or probable infection with filamentous fungi according to EORTC/MSGERC criteria:

  * Invasive aspergillosis
  * Mucormycosis
  * Fusariosis
  * Scedosporiosis
  * Other infection with filamentous fungus
* Subject or legal representative for minors, who has not expressed, after information, his opposition to the reuse of his data for scientific research purposes.

Exclusion Criteria

* Subject or (legal representative for minors) who has expressed his opposition to participating in the study
* Subject not with a liver transplant
* Subject under guardianship, curatorship or legal protection
Acetaminophen or Fluvastatin Compared to Placebo on the Transient Post-Dose Symptoms (PDS) Following an Intravenous (i.v.) Infusion of a Single Dose of Zoledronic Acid 5mg, in Post-menopausal Women With Low Bone Mass

This study will evaluate the efficacy of acetaminophen or fluvastatin in reducing the rate of occurrence and the severity of post dose symptoms that may occur during the 3 day period following a zoledronic acid infusion in post menopausal women with low bone mass.


Eligibility Criteria:
Inclusion Criteria:

1. Postmenopausal women greater than or equal to 45 and less than or equal to 79 years of age at randomization
2. Women who are clinically indicated for treatment with Bisphosphonates for osteopenia or osteoporosis with a documented central (spine or hip) Bone Mineral Density T Score less than or equal to 1.5

Exclusion Criteria:

1. Any prior treatment with intravenous Bisphosphonates
2. Oral treatment with Bisphosphonates for more than 8 weeks or within 6 months prior to the screening visit
3. Patients who are taking, and are unwilling or unable to stop taking, certain medications
4. Patients who require anticoagulant therapy
5. Patients with a known hypersensitivity to ibuprofen, ACET, bisphosphonates, statins or with allergies manifested by attacks of asthma, urticaria or acute rhinitis following
6. Proteinuria (protein detected on a urine dipstick) greater than or equal to 2+ at screening
7. Protocol specific laboratory values that fall out of range for this study
8. Ongoing infection (oral body temperature greater than or equal to 37.5C (99.5°F),chronic febrile disease or fever of unknown origin at screening or randomization
9. Active dental infection, unhealed dental extraction or planned oral surgery within 3 months after randomization
10. History of iritis, uveitis or chronic conjunctivitis
11. History of hypoparathyroidism, hyperparathyroidism or Paget's Disease
12. Partial or total removal of parathyroid or thyroid gland
13. History of malignancy of any organ system, treated or untreated, within the past 1 year whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin
14. Treatment with an investigational drug within the previous 30 days of screening
15. Patients with any medical or psychiatric condition which, in the opinion of the Principal Investigator, would preclude the participant from adhering to the protocol or completing the trial per protocol, or any patient who the Principal Investigator thinks should not participate in the study for any reason, including current drug or alcohol abuse

Other protocol-defined inclusion/exclusion criteria may apply