cyrilzakka/clinical-trials huggingface dataset:
AB-101 in Combination With B-Cell Depleting mAb in Patients Who Failed Treatment for Class III or IV Lupus Nephritis or Other Forms of Refractory Systemic Lupus Erythematosus

AB-101 (also known as AlloNK) is an off-the shelf, allogeneic cell product made of "natural killer" cells, also called NK cells. White blood cells are part of the immune system and NK cells are a type of white blood cell that is known to enhance the effect of monoclonal antibody therapies.

This clinical trial will enroll adult patients with lupus nephritis Class III or IV either with or without the presence of Class V who relapsed or did not respond to previous standard of care treatment approaches, or other forms of refractory systemic lupus erythematosus.

The primary objective is to assess the safety, tolerability and preliminary activity of AB-101 plus a B-cell depleting mAb (e.g., rituximab, obinutuzumab) after cyclophosphamide and fludarabine in adult subjects with relapsed/refractory lupus nephritis Class III or IV, with or without the presence of Class V, or other forms of refractory systemic lupus erythematosus.

Patients will be assigned to receive either AB-101 alone as monotherapy or in combination with a B-cell depleting mAb (e.g., rituximab, obinutuzumab). All patients will receive at least 1 treatment cycle of AB-101, followed by scheduled assessments of overall health and response status.

Patients may receive up to 2 cycles of treatment spaced 24 weeks apart.


Eligibility Criteria:
Inclusion Criteria for Lupus Nephritis:

* Adult subjects with biopsy proven lupus nephritis Class III or IV either with or without the presence of Class V according to the 2018 Revised International Society of Nephrology/Renal Pathology Society (ISN/RPS) criteria, who failed or did not respond to previous standard of care treatment approaches
* A kidney biopsy must be performed \< 24 weeks prior to the screening visit or during the screening period.
* Eligible subjects must have evidence of active disease on renal biopsy based on the modified NIH Lupus Nephritis activity and chronicity indices.
* Eligible subjects must have detectable anti-double stranded DNA antibody titers for enrollment.

Inclusion Criteria for Refractory Systemic Lupus Erythematosus:

* Diagnosis of SLE according to the 2019 EULAR/ACR Classification Criteria
* Total SLE Disease Activity Index (SELENA-SLEDAI score) \>8 sat screening
* Failed at least 12 weeks of 2 conventional therapies for SLE

Exclusion Criteria:

* Known past or current malignancy other than protocol stipulated low grade cancers, or curable cancer in complete response for \>2 years
* Known clinically significant cardiac disease
* Clinical evidence of significant unstable or uncontrolled acute or chronic diseases not due to SLE
* Subjects with known active viral infections or, if with a history of HBV or HCV infections, have a viral load above the institution's limit of quantitation
Evaluation of 4-Factor PCC in DOAC-associated Intracranial Hemorrhage

Intracranial hemorrhage (ICH) can occur due to traumatic and spontaneous events.1 The incidence of non-traumatic, spontaneous ICH is approximately 40,000 to 67,000 cases per year while the incidence of traumatic brain injury (TBI) is nearly 1.7 million annually

The authors found that AC use preinjury was associated with ICH progression, immediate neurosurgery intervention, and death after initial scan. AC use has also been associated with worse functional outcomes, and patients are less likely to be discharged home compared to those without AC use prior to injury.6 With increasing prevalence of AC, hospitals are seeing admissions for ICH, making knowledge of optimal AC reversal essential.

Eligibility Criteria:
Inclusion Criteria:

* • ≥18 years of age

  * ICH (traumatic and spontaneous)
  * Administration of at least one dose of 4F-PCC
  * Admitted to the MHS between July 1, 2018 and May 30, 2023
  * Rivaroxaban or apixaban use prior to admission

Exclusion Criteria:

* • Warfarin or dabigatran use prior to admission

  * Prisoners
  * Pregnancy
  * \<18 years of age
Innovations in Clinical Care of CE Approved Nucleus Cochlear Implant Recipients

This study is to evaluate new approaches to device fitting and diagnostics for cochlear implant users. The evaluation can be performed in the laboratory in an acute session or in real world environments with take-home device use to further validate their benefits. Each feature will be tested in a sub-study specific to that hearing care model. On average, each sub-study is expected to include approximately 20 subjects.


Eligibility Criteria:
Inclusion Criteria:

* Users of a CE approved Nucleus cochlear implant, resulting in open set speech understanding
* At least three months of experience with the cochlear implant.
* Older than 18 years when entering the study.
* Subject is fluent speaker in the language used for assessments.
* Open set speech understanding sufficient to complete the study protocol as judged by the investigator.
* Willing and able to provide written informed consent

Exclusion Criteria:

* Unable or unwilling to comply with the requirements of the clinical investigation as determined by the investigator.
* Additional health factors, known to the investigator, that would prevent or restrict participation in the audiological evaluations.
* Investigator site personnel directly affiliated with this study and/or their immediate families; immediate family is defined as a spouse, parent, child, or sibling.
* Cochlear employees or employees of Contract Research Organizations or contractors engaged by Cochlear for the purposes of this investigation.
* Currently participating, or participated within the last 30 days, in another interventional clinical investigation/trial involving an investigational drug or device.
COVID-19 Child Health Investigation of Latent Disease in Hamburg

The study measures infection rates and the presence of antibodies for SARS-CoV-2 (COVID-19) among in- and outpatients of all pediatric hospitals, as well as volunteers aged 0 to 18 years in Hamburg, Germany. Participants with a positive nasopharyngeal swab PCR or a positive antibody test enter the Follow-up phase of 6 months. The follow up includes a PCR and antibody testing of all household contacts at 0, 3 and 6 months, as well as laboratory testing of children to identify immunological, metabolic and genetic risk factors for infection and clinical outcome.

The study is divided into a Screening phase and a Follow-up phase. In the Screening phase, an obligatory polymerase chain reaction (PCR) in the nasopharyngeal swab and an optional serum antibody testing are carried out for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). An obligatory standardized questionnaire is used to evaluate symptoms and contacts, medical history and underlying conditions and the psychological effects of the Coronavirus disease 2019 (COVID-19) pandemic, as well as its effects on individual access to medical care. Children with a positive nasopharyngeal swab or antibody test, as well as their household contacts aged 0 to 18 years enter the Follow-up phase. During the Follow-up phase, blood and urine samples are taken from children for immunological analysis, HLA typing and untargeted metabolomics, enabling a broad analysis of the adaptive and innate immune response to SARS-CoV-2, as well as metabolic and genetic risk factors for infection and disease compared to age and sex-matched healthy controls. Furthermore, a repeated swab and antibody testing at 0, 3 and 6 months for children and adult household contacts is carried out to analyse household transmission of SARS-CoV-2 in children and adults and the persistence of antibodies.

Eligibility Criteria:
Inclusion Criteria:

* Children or Teenagers aged 0-18 years
* Patient in one of the participating centers or volunteer in the central C19.CHILD Study Clinic
* Informed consent from parents or guardians.
* Informed consent from children \>7 years (unless not capable)

Exclusion Criteria:

* Prematurity \<37 weeks of gestation
* Informed consent of parents and guardians not possible in spoken word or otherwise
* Informed consent not given
Safety, Tolerability and Pharmacokinetics of NN1731 in Healthy Volunteers

This trial is conducted in Japan. The aim of this trial is to assess the safety and tolerability of activated recombinant human coagulation factor VII analogue (NN1731, vatreptacog alfa (activated)) in healthy Japanese male subjects. In addition, the pharmacokinetics of NN1731 will be examined


Eligibility Criteria:
Inclusion Criteria:

* Japanese male subjects, who are considered to be generally healthy based on assessment of medical history, physical examination and clinical laboratory data at screening, as judged by the Investigator or Sub-investigator
* Body Mass Index (BMI) between 18.0 and 27.0 kg/m\^2 (inclusive)

Exclusion Criteria:

* Any clinical laboratory values deviated from the reference range at the laboratory (except for cases within physiological change) or any abnormal electrocardiogram (ECG) findings at the screening, as judged by the Investigator or Sub-investigator
* Presence or history of cancer or any clinically significant cardiac, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, dermatological, venereal, haematological, neurological, or psychiatric diseases or disorders
* Evidence of clinically relevant pathology or a potential thromboembolic risk as judged by the Investigator or Sub-investigator
* Presence or history of atherosclerosis, arteriosclerosis or thromboembolic events
* Any past history of migraine
* Overt bleeding, including from the gastrointestinal tract
Development of a New Prognostic Assessment Tool for Postoperative Myocardial Injury

Myocardial injury after noncardiac surgery (MINS) is common, silent, and strongly associated with morbi-mortality.

There are some evidences in the littérature showing that troponin elevation pre and/or postoperatively and surgical Apgar score are strongly and independently associated with postoperative morbi-mortality.

In this cohort study of orthopedic surgery patients (\> 50years), the aim is to determine MINS incidence and to assess wich peri-operative factors are associated with the occurrence of MINS. The final objective is to create a score to better identified the patients with a MINS and a poor outcome.


Eligibility Criteria:
Inclusion Criteria:

* \> 50 years
* orthopedic surgery (hip, knee, spine)
* written consent

Exclusion Criteria:

* no troponin measurement prior surgery
* sepsis
* acute coronary syndrome
* pulmonary embolism
* refusing to participate
* guardianship
Biodegradable Stent Implantation in Biliary Benign Strictures.

Spanish registry of resorbable stent implantation in biliary benign strictures.

This registry is sponsored by the Spanish Society of Vascular and Interventional Radiology (SERVEI) and conducted by the Research Group GITMI (Group of Research in Minimally Invasive Techniques) of the University of Zaragoza (Spain).

A software tool hosted on the official website of SERVEI and the journal Intervencionismo will be used for data collection a(https://estudios.watsoncme.com).

This is an prospective observational study of patients that have been implanted a biodegradable stent in the biliary tree.

Patients are recruited when the stent is implanted, and the investigators perfom a patients follow-up during 1, 3, 6, 12, 24, 36, 48 and 52 months.

Eligibility Criteria:
Inclusion Criteria:

* Older than 18 years-old
* Informed consent
* Non-lithiasic chronic bening single or multiple stenosis
* Possibility of follow-up plus 1 year

Exclusion Criteria:

* Under 18 years old
* Unsigned consent
* Non treatable coagulopathy
* Acute signs of infection
* Diagnosis of neoplasia
Stress Inoculation Through Virtual Reality in the Pediatric Electrophysiology Laboratory

The goal of this study is to assess the utility of virtual reality technology to aid in the mental health of patients with cardiac disease, specifically looking at decreasing anxiety and perceptions of pain from stressful procedures in the pediatric electrophysiology laboratory.

The investigators will perform a pilot study of 40 patients who are randomized to either standard of care preparation for an electrophysiology procedure (control arm) vs. Virtual Reality preparation (VR arm). Participants in control arm will have standard preparation for a procedure including discussion of the procedure with the provider the day before the procedure with all questions answered at that time. VR arm participants will have access to the Virtual Reality tour and gear 1 week prior to the procedure. VR arm participants will be instructed to watch the Virtual Reality tour at least three times prior to the procedure but will be encouraged to watch as often as the participants would like. The Virtual Reality equipment will measure how often participants complete the tour. All participants will undergo anxiety measures a total of four times: once at time of recruitment, day of procedure and then 1 week and 4 weeks post procedure. Participants will have cortisol salivary swabs performed 1 week before procedure (before VR use), pre-op visit, day of procedure, and immediately following procedure. Heart rate and blood pressure will be measured on day of procedure.

Eligibility Criteria:
Inclusion Criteria:

* Pediatric Cardiology patients between the age of 10 and 20 years old
* Undergoing cardiac electrophysiology procedure

Exclusion Criteria:

* Inability to wear virtual reality glasses
* Patients under 10 years old
* Prior psychiatric illness
The Role of CGRPand Nociceptin in Migraine

The release of the neuropeptide calcitonin gene-related peptide (CGRP) is thought to play a causative role in migraine. Nociceptin immunoreactivity and ORL-1 mRNA have been detected in human trigeminal ganglia where it was co-localized with CGRP. It may play a role in migraine pathogenesis. We are collecting the blood samples of migraineurs for analysis of these neuropeptides.

The release of the neuropeptide calcitonin gene-related peptide (CGRP) is thought to play a causative role in migraine. Nociceptin immunoreactivity and ORL-1 mRNA have been detected in human trigeminal ganglia where it was co-localized with CGRP. It may play a role in migraine pathogenesis. We are collecting the blood samples of migraineurs for analysis of these neuropeptides.

Eligibility Criteria:
Inclusion Criteria: patients with headache -

Exclusion Criteria: fever, congenital anomaly, CNS organic lesions

-
Quality of Care in AS IMPULSE Study

The purpose of this study is to narrow the gap between patients being diagnosed with severe aortic stenosis and those being appropriately monitored and treated. For this purpose a prospective survey of current practice (3 months) will be conducted followed by a six month period of intervention during which a variety of quality improvements measures will be implemented. There will then be a 3 month follow-up period during which the legacy of this initiative will be monitored during which no intervention will be carried out.

All patients meeting pre-specified criteria (severe aortic stenosis whether with or without symptoms) will be collected. There will be three phases at each site observation A, intervention, observation B. Observation A: In this phase, the nurse identifies cases with severe AS and collects their data. Baseline data for each patient will be collected and a follow-up will be done after three months for each patient to determine his/her outcome and the treatment that was decided on. There will also be an optional telephone follow-up to find out the patient's outcome.

Intervention: In this phase, the physician referring a patient for echocardiography will be notified of a finding of severe aortic stenosis: the nurse brings cases with severe AS to the attention of the referring physician within a week (via phone, e-mail or letter) to make them aware of the diagnosis.

Baseline and follow-up data will be collected for each patient as before. Moreover, more detailed data with regard to the patient's health status will be documented.

Observation B: Same as Observation Phase A

Eligibility Criteria:
Inclusion Criteria:

* Aortic valve area \< 1cm2
* Indexed aortic valve area \<0.6 cm/m2
* Maximum Jet velocity \> 4.0 m/sec
* Mean transvalvular gradient \> 40 mmHg

Exclusion Criteria:

* Non-severe aortic Stenosis (AS)
* Previous aortic valve replacement (AVR)
Network Support for Treatment of Alcohol Dependence

Relapse is the most serious problem in alcoholism treatment. The overall aim of the present study was to determine if a treatment directed at changing the patient's social network, from one that reinforces drinking behavior to one that reinforces sobriety, can create the conditions necessary for long-term treatment success. In addition, we intended to determine if explicit reinforcement for this change of social network (Contingency Management or ContM) would be more effective than the same network support intervention without contingent reinforcement for change.


Eligibility Criteria:
Inclusion Criteria:

* meet DSM-IV criteria for Alcohol Dependence
* at least 18 years old
* Willing to accept random assignment to treatment conditions

Exclusion Criteria:

* acute medical or psychiatric problems that require inpatient treatment
* reading ability below the fifth grade level
* lack of reliable transportation to the treatment site
* excessive commuting distance to site
* current dependence on drugs (except marijuana)
Using Virtual Reality for Patients With Gastrointestinal Disease

The primary aim of this study is to evaluate the effect and impact of a technology which creates a virtual reality (VR), personalized representation of a patient's endoscopic findings in comparison our standard practice (SP). Our study will compare the level of knowledge, understanding and satisfaction the patient and family have between those receiving SP and those receiving both SP and VR.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 8-25 years of age who are willing and able to participate
* Patients who recently had an endoscopic procedure at Boston Children's Hospital

Exclusion Criteria:

* Patients who are unable to provide consent due to age or developmental status
Comparison Study of High Frequency Percussive Ventilation With Conventional Ventilation

This study is designed to exam the effects of early management with high frequency percussive ventilation (HFPV) on patients with lung injury. Patients at risk for Acute Respiratory Distress Syndrome (ARDS) will be enrolled and randomized to one of two groups. One group will be managed with HFPV. The second group will be managed with conventional ventilation utilizing lung protective techniques. The primary endpoint of the study is rate of ventilator associated pneumonia. We hypothesized that use of HFPV in patients at risk for the development of ARDS will decrease the rate of ventilator associated pneumonia when compared to patients managed with conventional ventilation.

Specific Aim 1: This prospective randomized trial will enroll 180 patients with ALI/ARDS over a forty-eight month period. One cohort will receive conventional mechanical ventilation adhering to our well defined protocol of protective lung strategies. A second cohort will have these same strategies applied utilizing the VDR/HFPV. Out come measures will include; ICU/Hospital length of stay, pulmonary infectious complications, airway pressure related complications, PaO2/PaCO2 levels, hemodynamic profiles, and ventilators days.

We hypothesize that patients with Acute Lung Injury (ALI )and/or Acute Respiratory Distress Syndrome (ARDS) managed primarily with HFPV will have fewer ventilators days, fewer infectious complications, and shorter ICU/hospital lengths of stay than patients managed with conventional mechanical ventilation techniques, while maintaining similar oxygenation (PaO2), ventilation (PaCO2), metabolic (pH), and hemodynamic (cardiac output) parameters.

ARDS and ALI have been shown to cause elevations in circulating inflammatory mediators as well as local (alveolar) mediators. The presence of increased amounts of both circulating and alveolar cytokines (inflammatory mediators) has been associated with increased mortality in patients with ARDS/ALI. The pulmonary capillary bed is a rich source of these inflammatory cytokines and the effects of ventilator strategies on circulating and compartmentalized (alveolar) cytokine levels may affect outcome.

Specific Aim 2: Circulating and alveolar inflammatory mediators (IL-6, IL-1-beta, IL-10, and TNF-alpha) will be measured, and activation of other markers of increased synthesis of inflammatory mediators (NF-kappa B and p38 map kinase) will be determined in isolated peripheral blood and alveolar leukocytes.

We hypothesize that patients with ALI/ARDS managed with HFPV will have lower levels of circulating and alveolar pro-inflammatory cytokines (IL-6, IL-1-beta and TNF-alpha) as well as less activation of NF-kappa B and p38 MAP kinase from peripheral blood and alveolar leukocytes.

Eligibility Criteria:
Inclusion Criteria:

* PaO2/FiO2 \< 300 for less than 24 hours (Ratio of Partial pressure of oxygen to Fraction of inspired oxygen)

Exclusion Criteria:

* Documented Pneumonia,
* Documented Congestive Heart Failure,
* Immunosuppression,
* Enrolled in other interventional trial,
Work of Breathing in Premature Infants at Discharge

The purpose of this study is to compare how premature infants who required oxygen for at least 28 days during their time in the NICU (Neonatal Intensive Care Unit) breathe at discharge compared to premature infants who did not require oxygen for at least 28 days during their time in the NICU.

Work of breathing tests will be performed on premature infants who required oxygen for at least 28 days during their time in NICU. These same work of breathing tests will be performed in another group of premature infants who did not require oxygen for at least 28 days during their time in the NICU. The two groups will be compared.

Eligibility Criteria:
Inclusion Criteria:

* Infants born at greater than 26 weeks gestation, weighing less than 1500 grams at birth.
* Infants with diagnosis of BPD and without diagnosis of BPD

Exclusion Criteria:

* Infants with skeletal, neuromuscular, or abdominal surgical disorders that affect the accuracy of work of breathing measurements will be excluded.
Effects of Melatonin on Reperfusion Injury

Acute myocardial infarction is a major cause of mortality and morbidity. Primary percutaneous coronary intervention (pPCI) is currently the most effective treatment strategy in acute myocardial infarction. However, a sizable number of patients fail to restore optimal myocardial reperfusion, mostly because of the 'no-reflow' phenomenon. Melatonin is the chief indoleamine produced by the pineal gland, and a well-known antioxidant and free radical scavenger. Several studies have shown that melatonin protects against ischemia/reperfusion injury (IRI). In our previous study, melatonin markedly reduced infarcted area, improved cardiac function and reduced lactate dehydrogenase release in rats. The investigators planned to research the cardioprotective effects of intravenous melatonin administered prior to reperfusion and continued after restoration of coronary blood flow in patients with ST segment elevation myocardial infarction undergoing pPCI.


Eligibility Criteria:
Inclusion Criteria:

ST segment elevation myocardial infarction undergoing primary percutaneous poronary intervention

Exclusion Criteria:

* unconscious at presentation
* had cardiogenic shock
* had a history of myocardial infarction
* stent thrombosis
* renal insufficiency
* had previously undergone coronary artery bypass surgery