cyrilzakka/clinical-trials huggingface dataset:
Investigating the Efficacy, Safety and PK of Roxadustat (FG-4592) for Treatment of Anemia in Pediatric Patients With CKD

This open-labeled, multicenter study is designed to evaluate the efficacy, safety and PK/PD of roxadustat in ESA-naïve and ESA-treated pediatric patients with CKD Stages 3, 4, and 5, as well as end-stage renal disease (ESRD) who are receiving either hemodialysis (HD) or peritoneal dialysis (PD). The study will enroll patients between the ages of 2 to \<18 years in two sequential cohorts, with the older cohort of ages 12 to \<18 years enrolled first. Approximately 30 patients will be enrolled in each age-based cohort.


Eligibility Criteria:
Important Inclusion Criteria:

* Clinically stable CKD in the opinion of the investigator.
* Estimated glomerular filtration rate (Bedside Schwartz formula) of \< 60 ml/min/1.73 m2 (stage 3, 4 and 5 CKD) for non-dialysis patients, or patients who are receiving chronic dialysis (hemodialysis or peritoneal dialysis) for ESRD.
* For ESA-naïve patients (either NDD or DD; ESA-naïve is defined as those patients whose total duration of prior ESA exposure is ≤ 3 weeks within the preceding 12 weeks at the time informed consent is obtained), mean of two most recent central laboratory Hb values during the screening period obtained at least 2 days apart must be \< 11.0 g/dL. For patients currently receiving stable ESA dosing who will discontinue ESA and convert to roxadustat during study, mean of two most recent central laboratory Hb values during the screening period obtained at least 2 days apart must be ≥ 10.0 g/dL and ≤ 12.5 g/dL.
* Ferritin \>50 ng/mL and transferrin saturation \>10% (obtained from screening visit).
* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2x upper limit of normal (ULN) and total bilirubin (Tbili) ≤1.5x ULN at randomization (obtained from screening visit).
* Serum folate and vitamin B12 \> LLN (obtained from screening visit).

Important Exclusion Criteria:

* Uncontrolled hypertension as judged by the principal investigator in the 2 weeks prior to screening.
* Known hematologic disease other than anemia associated with CKD.
* Known malignancy within the past 5 years before screening.
* Any prior organ transplant or any planned organ transplant during the study period.
* Any RBC transfusion during the past 8 weeks before screening.
* Any condition leading to significant blood loss (e.g., gastrointestinal bleeding, surgical procedures) within 8 weeks before screening or during the screening period.
* History of chronic liver disease.
* Pure red cell aplasia (PRCA) or history of PRCA.
* History of epileptic seizures.
* History of hyperlipidemia or significant thrombotic/thromboembolic event (e.g., deep vein thrombosis, pulmonary embolism, stroke, myocardial infarction).
* History of thrombosis of an arteriovenous fistula/graft within 12 weeks prior to enrollment.
* Any active systemic or significant infection or episode of peritonitis within 30 days of screening.
* Any statin use within 30 days of screening.
* Any prior exposure to roxadustat or any other HIF-PH inhibitor.
Assessment of Body, Liver and Labile Plasma Iron and Their Association With Outcome and Immunological Recovery in Myelodysplastic Syndrome (MDS) or Acute Myeloid Leukemia (AML) Patients Undergoing Allogeneic Stem Cell Transplantation - ALLIVE (ALLogeneic Iron inVEstigators) Observational Trial

The ALLIVE (ALLogeneic Iron inVEstigators) trial aims at quantifying the extent and dynamic change of LPI occurrence during conditioning and at identifying LPI-predictive peri-transplant parameters. Further points of interest are the improvement of systemic iron overload (SIO) diagnostics and the correlation of different SIO parameters with outcome after transplantation. The results of this trial will help to design prospective interventional studies addressing therapeutic options in patients at risk for SIO-associated toxicity during allogeneic stem-cell transplantation (allo-SCT).


Eligibility Criteria:
Inclusion Criteria:

* Age \>= 18 years at the time of signing the informed consent form
* Signed informed consent
* Diagnosis of AML or MDS according to WHO classification
* Planned allogeneic stem cell transplantation after reduced intensity or myeloablative conditioning from related or unrelated donors
* At risk for iron toxicity as defined by ferritin \>500 ng/ml and/or history of more than 10 RBC transfusions prior to allo-SCT

Exclusion Criteria:

* Claustrophobia or other mental disorders making MRI imaging unbearable for the patient
* Cardiac pacemakers, metal implants splinters or other contraindications for MRI
* More than 1 Human leukocyte antigen (HLA) allele or antigen mismatch between donor and recipient
* Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study
* Patients with a history of chronic drug abuse or another illness which does not allow the patient to assess the nature and/or possible consequences of the study
* Patients who are not likely to follow the trial protocol (lack of willingness to cooperate)
RNA-seq Analysis of PBMC in Patients With OPLL

In this study, we planned to identify transcriptome expression profiles (circRNAs, lncRNAs, and mRNAs) from peripheral blood mononuclear cells (PBMCs) of 30 patients with OPLL and 30 other non-OPLL patients by high-throughput sequencing.Sequence analysis was used to predict miRNAs that might bind circRNAs and lncRNAs.Through bioinformatics analysis, competitive endogenous RNAs (cerRNAs), as well as coexpression networks among circRNAs, lncRNAs, miRNAs, and mRNAs, were constructed to provide key molecules and signaling pathways associated with OPLL.


Eligibility Criteria:
Inclusion Criteria:

1. Voluntarily participate in the clinical study and sign the informed consent;
2. All OPLL patients meet the diagnostic criteria set out in the JOA Clinical Practice Guidelines for Spinal Ligament Osification 2019;
3. Age ≥18, gender unlimited;
4. All non-OPLL patients and healthy volunteers have no serious diseases of the heart, lung, brain, liver, kidney and blood system, such as autoimmune diseases, tumors, psychosis, infectious diseases, etc., and have no bad habits or recent history of taking special drugs.

Exclusion Criteria:

1. Unable to sign the informed consent;
2. Patients who do not meet the inclusion criteria or diagnostic criteria;
3. \<18 years old;
4. Women planning to become pregnant/lactating/pregnant;
5. Complicated with serious heart, lung, brain, liver, kidney, blood system diseases, such as autoimmune diseases, tumors, mental illness, infectious diseases, drug addiction and other bad addicts;Those who have recently taken special drugs;
6. Individuals who do not agree to donate peripheral blood or who are obviously uncomfortable with drawing blood.
BinaxNow COVID-19 IgG Rapid Test Device and Antibody Self Test

Performance evaluation of the BinaxNOW™ COVID-19 IgG Rapid Test Device (Professional Use) and with BinaxNOW™ COVID-19 Antibody Self Test wehn used with fingerstick capillary whole blood and plasma samples. The BinaxNOW™ Antibody Tests are lateral flow tests that measure SARS-CoV-2 IgG antibodies.


Eligibility Criteria:
Inclusion Criteria:

1. Participant is 18 years of age or older.
2. Evaluable individuals with a prior confirmed SARS-CoV-2 infection with prior COVID-19 symptoms with symptoms onset \> 14 days prior to the study, or symptoms onset 8-14 days prior to the study, or symptoms onset 0-7 days prior to study.OR

   Evaluable individuals confirmed negative by SARS-CoV-2 RT-PCR using a sample obtained within 7 days prior to or on the day of the study.
3. Participant agrees to complete all aspects of the study.

Exclusion Criteria:

1. Participant has already participated in this study on a previous occasion.
2. Participant is enrolled in a study to evaluate a new drug.
3. Participant has a visual impairment that cannot be restored using glasses or contact lenses.
4. Participant is unable or unwilling to provide informed consent.
5. Participant is a vulnerable person as deemed unfit for the study by the Principal Investigator.
6. Participant has a condition deemed unfit to safely perform the test by the investigator.
7. Participant is a practising health-care professional or laboratory scientist / technician.
MultiStem® Administration for Stroke Treatment and Enhanced Recovery Study

A Phase 3 study to examine the safety and effectiveness of the allogeneic, adult stem cell investigational product, MultiStem, in adults who have suffered an acute ischemic stroke in the previous 18-36 hours.


Eligibility Criteria:
Primary Inclusion Criteria:

* Male or female subjects ≥18 years of age
* Clinical diagnosis of ischemic stroke involving cerebral cortex
* Occurrence of a moderate to moderately severe stroke with a persistent neurologic deficit documented by a NIHSS score of 8 to 20 (inclusive) that does not change by ≥4 points during the initial screening period
* A mRS score of 0 or 1 prior to the onset of symptoms of the current stroke

Primary Exclusion Criteria:

* Presence of a lacunar or a brainstem infarct
* Comatose state
* Brain hemorrhage
* Major neurological event such as stroke or clinically significant head trauma within 6 months of enrollment into the study
Valsalva Maneuver and Control in Reducing Pain During Spinal Injection

The study aimed to compare the effectiveness of Valsalva maneuver as non pharmacological approach and control in reducing pain during spinal injection.

This was an experimental study on 70 subjects with 35 subjects treated with Valsalva maneuver and 35 subjects treated as control from January to April 2019. Research subjects were female who underwent brachytherapy for the first time with spinal anesthesia. The effectiveness in reducing pain was assessed by using Visual Analogue Scale (VAS) and patient movement during the surgery.

Eligibility Criteria:
Inclusion Criteria:

* patients underwent elective surgery using spinal anesthesia
* patients who have not undergone spinal anesthesia before
* Physical status ASA I or II
* Signing informed consent

Exclusion Criteria:

* have a spinal anesthesia history
* contraindicated for spinal anesthesia
* subjects who cannot do Valsalva to 30mmHg pressure for 20 seconds
* have a allergic history to local anesthetics or opioid drugs
Electroporation for Treatment of Atrial Fibrillation

Comparison of pulmonary vein and left atrial posterior wall isolation durability and clinical outcome between radiofrequency and pulse field ablation in patients with persistent and longstanding persistent atrial fibrillation.

Patients with persistent and longstanding persistent atrial fibrillation will be randomized to control and investigational group.

In control group they will receive pulmonary vein and posterior wall ("box lesion") isolation with point by point radiofrequency ablation utilizing the CLOSE protocol with predetermined interlesion distance of up to 6 mm and predetermined ablation index/lesion size index.

In investigational group they will receive pulmonary vein and posterior wall ("box lesion" and additional ablations inside the "box") isolation with point by point pulse field ablation with a predetermined interlesion distance of up to 6 mm and predetermined energy delivery settings.

30 minutes after the last ablation point a high-density mapping of the left atrium will be performed.

Preprocedurally all patients will undergo computer tomography angiography of the left atrium, which will be processed resulting in a three dimensional anatomy reconstruction that will be utilized during the procedures in conjunction with the three dimensional mapping system. Also, left atrial wall thickness will be determined and displayed on the three dimensional anatomy reconstruction.

Before and after radiofrequency and pulse field ablation a five minute bipolar and unipolar intracardiac electrogram recording will be performed at at least two predetermined locations according to wall thickness (at the thinest and at the thickest part of the wall) for later analysis of changes due to different modes of ablation with correlation to lesion durability at a three month re-mapping procedure.

Collection of full blood before and 24 and 48 hours after the procedure to analyse activation of inflammation, coagulation, and also nevral tissue injury and endotelial injury due to ablation. Deviation of markers from the baseline value before the procedure will serve as a measure of activation. Markers analysed: troponin (ng/ml), D dimer (mg/l fibrinogen equivalent units), protein S100 (ng/ml), protein NSE (ng/ml), NT proBNP (pg/ml), high sensitivity CRP (mg/l), interleukin (IL) 6 (pg/ml), procalcitonin (ng/ml), fibrinogen (g/l), P selectin /pg/ml).

Postprocedurally pateints will undergo a remapping procedure three months later to determine pulmonary vein and left atrial posterior wall isolation durability.

Pateints will be followed up with clinical checkup and 1-7 day ECG holters at 3, 6, 12 months.

Eligibility Criteria:
Inclusion Criteria:

* atrial fibrillation recorded with 12-lead ECG, holter ECG or implantable device on two occasions at least one week apart

Exclusion Criteria:

* history of previous catheter ablation, history of previous heart surgery, life expectancy less than one year, any lifethreatening severe acute condition, acute deep venous thrombosis, presence of intracardiac masses or thrombi.
Ligasure II: Standard Stapling Versus Ligasure

Surgical staplers have become standard for ligation, division, resection, anastomosis and closure in many surgical procedures. Staplers are utilized in thoracic surgery routinely for pulmonary parenchymal resection and closure, ligation of vessels and bronchi. In addition, closure of incomplete fissure/s is a frequent need in pulmonary surgery. Although generally safe and efficacious, staplers and staple loads are expensive, and can result in micro air leaks. The LigaSure Vessel Sealing System presents as a potentially faster and less expensive alternative to staplers. The LigaSure Vessel sealing system utilizes a combination of heat generated via bi-polar radiofrequency energy and precise jaw pressure to denature the collagen and elastin in tissue and blood vessels. The newly released Force Triad Generator and the Impact, a 10 mm jaw sealing device (Ligasure system, COVIDIEN Society) may offer improved performance in terms of tissue sticking due to an improved sealing algorithm, and to the jaw configuration of the Impact. The study main objective is to compare the quality of parenchymal pneumostasis after fissure closure achieved with staplers vs that achieved with LigaSure.


Eligibility Criteria:
Inclusion Criteria:

* Patients older than 18 years
* Patients scheduled for thoracotomy, lobectomy or bilobectomy
* Patients must give informed consent

Exclusion Criteria:

* Patient is unwilling or unable to provide informed consent
* Patients who can not tolerate thoracotomy
* Patients who require extensive dissection to release adhesions which may result in air leak and/or bleeding unrelated to the quality of the parenchymal seal achieved by the devices in question
* Patients with no parenchymal bridge between lobes; 100% complete fissure.
* Patients with complete incomplete fissure with a thickness \> 1.5 cm measure intraoperatively
Allogeneic Bone Paste Versus Allogeneic Bone Powder

Autogenous bone graft has been considered the gold standard in Guided Bone Regeneration (GBR) technique used for bone augmentation. However, there are disadvantages associated with autograft use such as limited amount of available bone and increased morbidity for the patient at the sampling site. Several biomaterials have been used as a replacement of the autogenous bone. Viral-inactivated bone allograft powder is an alternative that has proven efficacy and tolerance. This study aims to assess the non-inferiority of viral-inactivated allogeneic bone paste compared to a viral-inactivated cortico-cancellous allogenic bone powder in achieving the ideal bone volume.


Eligibility Criteria:
Inclusion Criteria:

1. Patient aged ≥ 18 years old
2. Patient able to read, understand and give written consent to participate in the study
3. Patient affiliated with a social security system or beneficiary of such a system
4. Partially edentulous patient with 1 to 2 intercalary missing teeth or a terminal gap with distal vertical and lateral support bone volume
5. Presence of a bone deficit requiring horizontal and / or vertical bone augmentation (stage 4 or 5 of the Benic and Hammerle classification) treated by GBR for delayed placement of up to 4 dental implants
6. Possibility of acquisition by CBCT for the required protocol visits

Exclusion Criteria:

1. General contraindication to bone graft and implant surgery
2. Pregnant woman or planned pregnancy during the study period or breast-feeding woman;
3. Patient who has had a bone augmentation by GBR during the previous 12 months, in the area targeted for filling with the allogeneic material
4. Patient who received less than 3 months ago a CBCT acquisition at the operative site
5. Patient simultaneously requiring more than one GBR augmentation in the same quadrant
6. Patient with signs of local infection at the targeted graft site
7. Systemic, metabolic or autoimmune disease that may adversely affect healing of soft and bone tissue (eg, unbalanced type 1 or type 2 diabetes)
8. Use of treatments (chemotherapy or radiotherapy) or drugs (bisphosphonates, chronic steroids) known to potentially interfere with tissue healing
9. Patient presenting a dental plaque objectified by an oral examination (Loe SILNESS ≥ 2 on more than 50% of the dental surfaces)
10. Patient smoker of more than 10 cigarettes a day
11. Any other condition that, in the investigator's opinion, would be detrimental to the safety of the patient or fail to meet the requirements of the protocol
Evaluation of PSMA Antagonist Produced by Two Different Methods

Patients with metastatic prostate cancer will undergo two protocol 68Ga-PET scans within 24-48 hours with 68Ga-PSMA-cyclotron and 68Ga-PSMA-generator radiotracers. The goal of the study is to evaluate repeatability and equivalence across the different 68Ga-PSMA production methods. This research study is being conducted to assess whether the PET/CT imaging results, as generated from the two different 68Ga production methods, are equivalent.

Patients with metastatic prostate adenocarcinoma will be enrolled in the study and will undergo two 68Ga-Prostate Specific Membrane Antigen- Positron Emission Tomography (PSMA-PET) scans within 24-48 hours. The difference between the two scans is that the radiotracer used in each scan will be produced with a different method (68Ga-PSMA-cyclotron and 68Ga-PSMA-generator produced). The first scan will occur after a baseline clinical evaluation, which will include a history, physical, and baseline lab draw. After each scan, blood draws will be obtained.

The purpose of this study is to evaluate equivalence of two processes to create 68Ga-HBED-PSMA and compare dosimetry, biodistribution and whole body excretion/ metabolism. Furthermore, the research team will perform dynamic analysis of the PET scans to investigate repeatability of whole-body 68Ga-PSMA-generator Ki Patlak imaging against that of conventional whole-body 68Ga-PSMA- SUV imaging and evaluate equivalence of whole-body 68Ga-PSMA Ki Patlak imaging between the two processes to create 68Ga-HBED-PSMA (68GA-PSMA-cyclotron vs. 68Ga-PSMA-generator). Patients will afterwards receive standard of care treatment and follow up imaging.

Eligibility Criteria:
Inclusion Criteria:

Subjects must meet all of the following criteria to be enrolled in this study:

* Aged 21 years or older and below 80 years of age
* Signed written informed consent and willingness to comply with protocol requirements
* Histologically confirmed diagnosis of metastatic prostate cancer
* Staging imaging exam confirming metastatic disease, e.g. total body MRI, or CT chest/abdomen/pelvis, 99mTc bone scan, NaF PET

Exclusion Criteria:

* Laboratory values:
* Serum creatinine \>2.5 mg/dL
* AST (SGOT) \>2.5x ULN
* Bilirubin (total) \>1.5x ULN
* Serum calcium \>11 mg/dL
* Presence of any other co-existing condition which, in the judgment of the investigator, might increase the risk to the subject.
* Presence of serious systemic illness, including: uncontrolled inter-current infection, uncontrolled malignancy, significant renal disease, or psychiatric/social situations, which might limit compliance with study requirements.
* Other severe acute or chronic medical condition(s) or laboratory abnormality(ies) that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and in the judgment of the investigator, would make the patient inappropriate for entry into this study.
* Inability to lay on the scanner table for the required period of time, e.g., due to bone pain or claustrophobia.
TrueRelief Efficacy for Post-cesarean Pain (ELECTRON)

This is a randomized trial of 134 individualized post-cesarean delivery who will be randomized to twice daily use of non-invasive bioelectronic treatment with TrueRelief device or identical appearing sham device for post-cesarean pain management.


Eligibility Criteria:
Inclusion Criteria:

• Post cesarean delivery (combined vaginal/cesarean deliveries are not eligible) Singleton, or twin gestation

Exclusion Criteria:

* Known history of opioid use disorder, by medical record review
* Contraindication to opioids
* Contraindications to both acetaminophen and ibuprofen
* Significant surgical procedures (e.g., hysterectomy) prior to randomization as pain trajectory will be completely different
* Fetal or neonatal death prior to randomization
* Inability to randomize on postoperative day 0
* Inability to participate in twice daily use of non-invasive bioelectronic treatment during inpatient stay as assessed by research staff
* Language barrier (non-English or Spanish speaking)
* Participation in another intervention study that influences the primary outcome in this trial
Polysomnography Validation of the Sansa Device

The objective of this study is to evaluate the performance of the Sansa device for the diagnosis of sleep disordered breathing.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* able to read, understand, and sign informed consent documentation
* willing to sleep with the Sansa device and PSG simultaneously in the sleep clinic
* suspected or known to have sleep disordered breathing

Exclusion Criteria:

* exhibit deformities of the chest that would interfere with sensor placement
* have broken or injured skin that would interfere with sensor placement
* known to experience adverse reactions to medical-grade adhesive
* diagnosed with hypoventilation
* diagnosed with severe chronic obstructive pulmonary disease
* exhibit symptoms of significant non-respiratory sleep disorders
* diagnosed with a neuromuscular disorder leading to muscle weakness
* chronically use supplemental oxygen at night or during the day
* pregnant
* scheduled to undergo titration of a hypoglossal nerve stimulation device
* undergo permanent pacing with an implanted pacemaker
* diagnosed with congestive heart failure with an ejection fraction less than 45%