cyrilzakka/clinical-trials huggingface dataset:
Extracorporeal CO2 Removal in COPD Exacerbation

The minimally invasive extracorporeal carbon dioxide removal may decrease the respiratory load during chronic obstructive pulmonary disease (COPD) exacerbation, reducing the need to advance the respiratory care toward invasive mechanical ventilation in patients refractory to non-invasive ventilatory support (NIV), or decreasing the need of ventilatory support in patients already invasively ventilated, thereby accelerating the weaning process.

The investigators intend to perform a multi-center experimental non randomized single arm prospective study to investigate the efficacy of the Decap Smart in reducing the intubation rate or the duration of invasive mechanical ventilation in patients with COPD treated either with NIV or invasive mechanical ventilation (IMV) for severe respiratory failure and hypercapnia. The results of the study will be compared to the data available in the literature.


Eligibility Criteria:
Inclusion Criteria:

* COPD
* severe acute respiratory failure
* after at least two hours of continuous application of non-invasive ventilatory support (NIV):
* arterial pH ≤7.30 with an arterial pressure of CO2 (PaCO2) \>20% of the baseline value and one of the following:
* respiratory rate ≥30 breaths/min;
* use of accessory muscles or paradoxical abdominal movements

Exclusion Criteria:

* failure to obtain consent
* hemodynamic instability (MAP \< 60 mmHg) despite infusion of vasoactive drugs
* contraindications to the administration of i.v. heparin (heparin induced thrombocytopenia, hemorrhage, etc.)
* body weight \>120 kg
* contraindication to continuation of active treatment (DNR)
REgenerative CardiOsphere iNjection to STRengthen dysfUnCTional Hearts

A double blinded and placebo-controlled, dose escalation, single-center safety and preliminary efficacy study of cardiospheres delivered via NOGA MYOSTAR injection catheter in subjects with chronic ischemic cardiomyopathy. The objective is to achieve and document myocardial regeneration in patients with chronic scar.


Eligibility Criteria:
Inclusion Criteria:

* Adults with ischemic cardiomyopathy (EF \>10 and \<40% by functional imaging \[ECHO, CT, MRI, contrast ventriculography\])
* Symptomatic heart failure of NYHA Class 2 or 3
* History of prior remote (\>3 mo) myocardial infarction and/or documented obstructive coronary artery disease with corresponding dysfunctional segments by functional imaging
* Age \> 18 years
* Ability to provide informed consent and follow-up with protocol procedures

Exclusion Criteria:

* Documented myocardial infarction within 3 months (120 days)
* Known or suspected left ventricular thrombus
* Non-cardiovascular disease with life expectancy of \< 3 years
* Absence of significant gadolinium-enhanced scar (\>10% of LV mass) at baseline MRIc
* Positive panel-reactive antibodies (PRA)
* Need for further revascularization clinically indicated at the time the patient is assessed for participation in the clinical trial. This will be determined by a cardiologist who is not an investigator in the clinical trial. No further revascularization may be indicated by no arteries with significant stenosis, the location, and extent of any stenosis may not be suitable for angioplasty, the distal vessels may not be suitable for placement of bypass grafts, and/or the patient declines angioplasty or bypass surgery.
* NYHA IV heart failure
* History of aortic stenosis/insufficiency
* Requirement for chronic immunosuppressive therapy
* Participation in an on-going protocol studying an experimental drug or device
* Diagnosis of congenital or genetically-transmitted cardiomyopathy
* Current alcohol or drug abuse because of anticipated difficulty in complying with protocol-related procedures
* Pregnancy or child-bearing potential without use of effective contraception. Men intending to "father" children are also excluded.
* Human Immunodeficiency virus infection
* Viral hepatitis
* Uncontrolled diabetes and/or hemoglobin A1C \> 8.5%
* Abnormal liver function (SGPT \> 3 times the upper reference range) and/or hematology (hematocrit \<25%, WBC \<3000, Platelets \<100,000) studies without a reversible, identifiable cause
* Ventricular tachycardia or fibrillation not associated with an acute ischemic episode
* Canadian Cardiovascular Society Angina Class 3 or 4
* History of cardiac tumor or cardiac tumor demonstrated or suspected on MRI other imaging modality
* Previous stem cell therapy/treatment
* Individuals who are not fluent in English
Creatine Safety, Tolerability, & Efficacy in Huntington's Disease (CREST-E)

Huntington's disease (HD) is a slowly progressive disorder that devastates the lives of those affected and their families. There are no treatments that slow the progression of HD, only mildly effective symptomatic therapies are available.Creatine monohydrate is considered a nutritional supplement. The purpose of CREST-E is to test whether high-dose creatine can slow the progressive functional decline that occurs in persons 18 years or older with early clinical features of HD. The long-term safety, tolerability and effectiveness of up to 40 grams daily creatine compared to placebo is studied. A variety of biological processes are assessed for markers of disease activity or progression and creatine effects. Up to 50 active research centers globally will enroll 650 subjects.


Eligibility Criteria:
Inclusion Criteria:

* Male or female ages 18 or older.
* Clinical features of HD AND confirmatory family history of HD; OR Clinical features of HD AND CAG repeat expansion greater or equal to 36.
* Stage I or II of illness (TFC greater or equal to 7).
* Ambulatory and not requiring skilled nursing care at the time of enrollment.
* Must be capable of providing informed consent and complying with trial procedures.
* Additional inclusion criteria apply.

Exclusion Criteria:

* History of known sensitivity or intolerability to creatine monohydrate.
* Exposure to any investigational drug within 30 days of randomization (Baseline visit).
* Use of supplemental creatine at a dose greater than 10 grams within 30 days of randomization (Baseline visit).
* Screening laboratory abnormalities that in the judgment of the investigator would jeopardize safe conduct of study.
* Clinical evidence of unstable medical illness.
* Clinical evidence of unstable psychiatric illness.
* Additional exclusion criteria apply.
A Randomized Controlled, Open, Single-center Clinical Study Evaluating the Efficacy and Safety of Umbilical Cord Blood Mononuclear Cells in Patients with Refractory Immune Effector Cell-related Hemocytopenia

The purpose of this study was to evaluate the safety and efficacy of umbilical cord blood mononuclear cell in the treatment of refractory immune effector cell-related hemocytopenia by observing the efficacy related factors and adverse reactions.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years old (including boundary values), gender is not limited
2. ECOG score 0-2 points
3. Expected survival ≥6 months
4. Patients who have received immune effector cell therapy (marketed CAR-T cell therapy or dual antibody therapy) (no target), have grade 3-4 hemocytopenia after treatment, and do not recover to grade 2 within 3 weeks after conventional treatment. Defined as follows:

1) The neutrophils again decreased to grade ≥3 within 1 week after G-CSF discontinuation, or 2) Unable to detach from red blood cell or platelet transfusion (infusion time less than one week requires re-infusion) (5) Understand the research protocol and sign the informed consent voluntarily

Exclusion Criteria:

1. Patients who intend to undergo autologous hematopoietic stem cell transfusion or have undergone autologous hematopoietic stem cell transfusion
2. Significant lack of compliance to complete the study plan (such as suffering from uncontrolled mental illness, etc.)
3. Allergy or known allergy to any drug active ingredients, excipients, and blood products or preparations included in this study
4. Pregnancy, breastfeeding, planning pregnancy, or unwillingness to use effective contraception as required by research
5. There are other conditions that researchers believe are not suitable for inclusion
Reducing Blood Pressure in Patients With High Cardiovascular Risk in the Safety-Net

BP-REACH is a study of a team-based (pharmacist and health coach) program for lowering blood pressure for people with a prior stroke or heart attack in the Los Angeles Department of Health Services public healthcare system.

The goal of this clinical trial is to test if this team based program is better at helping people reduce their blood pressure than usual care for people with prior heart attack or stroke. The main questions it aims to answer are:

* Do people in the REACH BP program have lower blood pressure at 12 months compared to those getting usual care?
* Do people in the REACH BP program have better Life's Essential 8 scores and patient experience compared to those getting usual care?

Hypertension is the leading contributor to preventable death and a major risk factor for recurrent cardiovascular events. To enhance BP control after stroke or myocardial infarction (MI), multilevel interventions are needed that incorporate health system, patient, and community level factors.

BP-REACH aims to test the impact of an intervention on systolic blood pressure (SBP) for individuals with a history of stroke or MI in a randomized controlled trial in the Los Angeles Department of Health Services public healthcare system. The primary outcome will be change in systolic blood pressure (SBP) at 12 months.

Hypothesis: Patients randomized to the intervention will achieve \>2.4 mm Hg greater reduction in SBP at 1 year versus those randomized to usual care.

The study population will include participants from the inpatient and outpatient settings in Los Angeles County Department of Health Services health centers. The participants will be randomized in a 1:1 fashion to usual care or intervention, stratified by site, language and cardiovascular event (myocardial infarction, stroke). Outcomes will be collected from all participants at Baseline, 3 month and 12 month timepoints. The primary outcome is SBP.

Participants randomized to the intervention arm will receive additional a home blood pressure monitor, monthly phone calls from a health coach, and medication initiation and titration by a clinical pharmacist. The pharmacist will follow Los Angeles County Department of Health Services expected practices, which align with the ACC/AHA guidelines for blood pressure control and AHA guidelines for Secondary Stroke Prevention.

Eligibility Criteria:
Inclusion Criteria:

* Patients of LA General Medical Center, Rancho Los Amigos, Olive Medical Center or Harbor-UCLA Medical Center with ischemic stroke, hemorrhagic stroke, or myocardial infarction
* English or Spanish speaking
* Systolic blood pressure (SBP) ≥ 130 mm Hg

Exclusion Criteria:

* Age \< 35 years
* SBP \< 130 mm Hg
* Only speaks a language other than English or Spanish
* Cannot provide informed consent due to dementia or aphasia
Study of the Effect of Diabetes on the Incidence and the Extent of Coronary Artery Disease

In the present study the investigators will measure the extent of coronary artery disease via coronary angiography and the correlating risk factors.

In the present study the investigators will examine the risk factors determining the development, extent and the manifestation of coronary artery disease. The study will recruit patients undergoing coronary angiography for clinical purposes.

Eligibility Criteria:
Inclusion Criteria:

* Any subject eligible for coronary angiography with or without known CV disease for clinical reasons.

Exclusion Criteria:

* Patients revascularized in the past, with either coronary artery bypass grafting or percutaneous coronary intervention, will be excluded from the study since it is not possible to describe the extent of CAD in these patients.
* Moderate or severe aortic stenosis.
Thermoregulation During a 25-km Open Water Race

Open water swimming is a swimming discipline which takes place in outdoor water such as open oceans, lakes, and rivers. Elite swimmers are exposed to hypothermia when swimming in cold water, especially in long duration races, such as the 25-km race. The objective of this study is to evaluate the change in body core temperature in swimmers with continuous temperature monitoring during a 25-km race. The secondary objective is to identify the predictors of hypothermia and hypothermia-related drop-out.


Eligibility Criteria:
Inclusion Criteria:

* competitors of the 25-km French Open Water Championship
* participants who volunteered for this study
* written consent was obtained from all participants, as well as their legal representatives when applicable (i.e. parents for under age participants).

Exclusion Criteria:

* swallowing disorders
* transit disorders
* MRI scheduled within 48 hours
Healthcare Professionals' Attitude Towards Clinical Research in the United Arab Emirates

Abu Dhabi Health Services Company (SEHA) is already in the process of providing support for research infrastructure, such as trained staff, medical facilities, funding, and training needs for its healthcare professionals (HCPs). An HCP's own interest in clinical research is an individualistic trait that SEHA wants to target and develop, complementary to its medical staff specialty, educational background, and willingness to learn.

The investigators' aim with this study is to understand the participants' perspective on challenges and barriers stopping them from conducting research and what supportive measures they have around them from the organization and the United Arab Emirates (UAE) that back their growth as research professionals at SEHA.

The investigators' aim with this study is to understand healthcare professionals' (HCPs) perspective on challenges and barriers stopping them from conducting research and what supportive measures they have around them from the organization and the United Arab Emirates (UAE) that back their growth as research professionals at Abu Dhabi Health Services Company -SEHA.

Investigators hypothesize that participants will give positive feedback on their interest in conducting clinical research but will outline barriers like lack of training opportunities, trained clinical operations staff, organizational support, protected time, etc. Moreover, they will also highlight the lack of data system training, participant accrual challenges, software interoperability issues, sponsor and contract research organization (CRO) issues, and lack of funding opportunities as major barriers to conducting research in the UAE.

Eligibility Criteria:
Inclusion Criteria:

* Current SEHA Employee
* Identify as a Healthcare Professional

Exclusion Criteria:

* Non-SEHA individuals
* Non-Healthcare professionals
A Feasibility Study to Determine PET/CT Imaging of Blood Flow to the Bone

To evaluate if a commonly used medical bone scan, called positron emission tomography/computed tomography (PET/CT) with sodium fluoride can measure bone blood flow to the hip.

The purpose of this research is to validate technique on a commonly used medical bone scan, called positron emission tomography/computed tomography (PET/CT) along with sodium fluoride as the tracer for determining blood flow to the bone. Up to 12 subjects will have PET/CT scans so that we can determine the repeatability and reliability of the images prior to using PET/CT for this use on subjects in the Phase 1b part of Dr. Nancy Lane's clinical research study entitled "A Phase 1, Randomized, Double-Blind, Placebo-Controlled Single and Multiple Ascending Dose Study of the Safety and Tolerability of Intravenous LLP2A-Alendronate in Adult Men and Women with Osteopenia Secondary to Glucocorticoids" (IRB Protocol #866350).

Eligibility Criteria:
Inclusion Criteria:

Subjects must meet all of the following criteria to be included in the study.

1. 20 - 75 years old
2. Must be ambulatory and able to attend all appointments
3. Women must agree to use one of the following methods of birth control for the duration of the clinical trial:

   systemic hormonal contraceptive (oral, injected, transdermal), intrauterine device, double barrier (e.g., cervical cap or diaphragm with condom or spermicide). Men with female partners must agree to use double barrier contraception, unless their partner is using systemic hormonal contraceptives or has an intrauterine device
4. Subject undergoing PET/CT scans must have the ability to lay motionless for up to 30 minutes.

Exclusion Criteria:

1. Subjects undergoing PET/CT scans must not be breast-feeding.
2. History of hypersensitivity to fluoride
Innovation in the Treatment of Persistent Pain in Adults With NF1: Implementation of the iCanCope Mobile Application- Clinical Trial

To demonstrate the initial feasibility and determine preliminary impact on clinical outcomes of the iCanCope-NF program in a pilot RCT. If successful this pilot study will support conducting a larger randomized control trial (RCT). The primary research question is what is the feasibility of the iCanCope-NF program? The investigators define feasibility as (1) rates of accrual and dropout, daily log-ins, engagement, and outcome measures completed and (2) perceptions regarding intervention acceptability and satisfaction; and what are the levels of engagement. log-ins, with the intervention? The secondary questions are: (1) how does the iCanCope-NF program compare with the control condition in differences of pain and pain-related activity limitations, sleep functioning, emotional functioning (depression, anxiety), opioid usage, pain catastrophizing, self-efficacy, respondent burden (i.e. Physical Functioning, R, Vitality, Social Functioning, Role-Emotional, and Mental Health), and psychological flexibility immediately post-treatment (T2), (2) does the iCanCope-NF + CM increase the engagement of the iCanCope-NF program as compared to iCanCope-NF without CM, and do their corresponding levels of pain and pain-related activity decrease with CM?, and (3) do individuals with NF1 utilize the Mindfulness based alternative approaches (MBAA) to help reduce pain symptoms? The investigators hypothesize that by customizing and including MBAA to the program for adults with NF1, that individuals who engage regularly as seen through Analytics Platform for Evaluating Effective Engagement (APEEE) application, will acquire new sets of skills to facilitate pain management, while pain as reported with the Brief Pain Inventory will decrease.


Eligibility Criteria:
Inclusion Criteria:

* adults 18+
* able to read and understand English at 5th grade level
* permanently reside in the United States
* have pain interference aggregate scores of three or more in the last two weeks using the Brief Pain Inventory-Short Form (BPI-SF) scale

Exclusion Criteria:

* have an undiagnosed case of NF1
* have documented major co-occurring psychiatric disease
* have moderate to severe cognitive deficits
* have depression assessed using the Patient Health Questionnaire (PHQ-9) or anxiety assessed using the Generalized Anxiety Disorder scale (GAD-7) greater than or equal to the appropriate thresholds (10=mild major depression; 5=mild severe anxiety)
New Formulation and Food Effect Study of BIIB074

The primary objectives of the study are to assess the relative bioavailability of the BIIB074 direct compression formulation (DCF) to the BIIB074 roller compaction formulation (RCF) and to determine the effect of a high-fat meal on the pharmacokinetics (PK) of the BIIB074 DCF. The secondary objective of the study is to assess the safety and tolerability of BIIB074 administered as the DCF following single oral dose administration in healthy participants.


Eligibility Criteria:
Key Inclusion Criteria:

* Must have a body mass index between 18 and 30 kg/m2, inclusive.
* Must be in good health as determined by the Investigator, based on medical history and screening evaluations.
* Ability to consume and tolerate the entire high-fat breakfast within a 30-minute timeframe.

Key Exclusion Criteria:

* History of, or positive test result at Screening for, human immunodeficiency virus (HIV).
* Positive test result at Screening for hepatitis C virus antibody.
* Positive test result at Screening for hepatitis B virus (defined as positive for hepatitis B surface antigen and/or hepatitis B core antibody).
* Previous exposure to BIIB074.
* Consumption of xanthine/caffeine-containing products (e.g., energy drinks, coffee, tea, caffeinated soda) within 48 hours of Day -1 and an unwillingness to refrain from product use during study participation.
* History of alcohol or substance abuse (as determined by the Investigator), a positive urine drug screen or alcohol breath test at Screening or Day -1, or an unwillingness to refrain from alcohol, or illicit or recreational drugs, during the study.
* History or evidence of habitual use of tobacco- or nicotine-containing products within 90 days of Screening, or a positive cotinine screen at Screening or Day -1.

Note: Other protocol defined Inclusion/Exclusion criteria may apply
Music Therapy Intervention During Kidney Biopsy.

Kidney biopsy (KB) is an invasive procedure that is very useful in diagnosing kidney disease in both the native kidney and the transplanted kidney. Patients undergo KB can feel anxiety and pain. Pain is considered one of the worst experiences for patients and anxiety affects the sympathetic nervous system, the endocrine system and the immune system. The aim of this preliminary study was to evaluate the influence of MTI as a complementary/nonpharmacological intervention on heart rate variability, anxiety and pain and promote more compliant behaviours during KB.


Eligibility Criteria:
Inclusion Criteria:

* age over 18 years
* not severe neurological or psychiatric conditions
* not hearing impairment

Exclusion Criteria:

* age under 18 years
* severe neurological or psychiatric conditions
* hearing impairment