cyrilzakka/clinical-trials huggingface dataset:
Impact of Exercise Training on Ischemia With Non-Obstructive Coronary Arteries (INOCA): The ExINOCA Study

The purpose of the study is to identify causes of chest pain in patients experiencing chest pain with no signs of narrowing of the coronary arteries of the heart, and to investigate whether physical exercise can improve coronary microvascular function.

Hypotheses:

The first hypothesis is that in INOCA, with reduced function of microvasculature of the heart, this reduced function also occurs in other organs of the body.

The second hypothesis is that regular physical activity (aerobic exercise training) can improve coronary microvascular function, reduce symptoms, and that there is a parallel improvement in vascular function in other organs of the body.

A significant number of patients suspected of chronic coronary syndrome do not have coronary artery obstruction and in a large proportion of these, their symptoms are attributed to coronary microvascular dysfunction (CMD), a condition known as ischemia with no obstructive coronary artery disease (INOCA). Despite a considerable patient population affected by INOCA, the specific mechanisms underlying CMD are not fully understood, often resulting in a lack of targeted treatment. There is evidence to suggest that exercise capacity is linked to coronary microvascular function, positing that exercise training could potentially reverse microvascular dysfunction and address its mechanistic origins, a hypothesis yet to be explored.

This study aims to identify mechanisms underlying CMD in angina and to assess whether exercise training can improve the condition.

The current study is a randomized controlled trial testing the effect of exercise training in patients with CMD. 100 patients will be randomized 1:1 to exercise training or control. The primary outcome is coronary microvascular function, secondary outcomes include symptoms and microvascular function in cutaneous tissue, skeletal muscle, and adipose tissue.

Eligibility Criteria:
Inclusion Criteria:

* Coronary microvascular dysfunction, defined as myocardial bloodflow reserve (MBFR) \< 2.5 or hyperemic myocar-dial blood flow (hMBF)\<2.3 ml/g/min using \[15O\]H2O-PET
* No obstructive coronary artery disease

Exclusion Criteria:

* Females of childbearing potential (defined as a premeno-pausal female capable of becoming pregnant). The female patient must either be postmenopausal, defined as amen-orrhea for at least 1 year, or surgically sterile
* Heart failure, defined as left ventricular ejection fraction of less than 40%
* Uncontrolled hypertension defined as blood pressure above target 140/90 for all
* Co-morbidity resulting in \<1 year expected survival
* Considered by the investigator, for any reason, to be an un-suitable candidate for the study.
* Unable or unwilling to exercise, e.g. due to arthritis or in-jury\*
* Already are regularly physically active and/or have a maxi-mal oxygen uptake \>45 ml/kg/min
Mechanism of Effectiveness of Neurosurgery Treatments for Durable Pain

The participants in the study are patients who undergo surgery to damaged nerve transmission and processing system in the nervous system as part of the routine clinical treatment that will not be affected by the proposed study. Patients who are candidates for procedures are referred from all over the country and undergo a multidisciplinary evaluation in the framework of the Palliative Pain Management Clinic, which operates exclusively in Israel at the Sourasky Medical Center in Tel Aviv.

The participants in the study are patients who undergo surgery to damaged nerve transmission and processing system in the nervous system as part of the routine clinical treatment that will not be affected by the proposed study. Patients who are candidates for procedures are referred from all over the country and undergo a multidisciplinary evaluation in the framework of the Palliative Pain Management Clinic, which operates exclusively in Israel at the Sourasky Medical Center in Tel Aviv.

During the preoperative evaluation, patients will be given an explanation about the possibility of participating in the study. Patients who agree to participate will sign an informed consent form.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing neurosurgical surgery for resistant pain
* Ability to sign informed consent form for participation in the study
* A functional level is sufficient for cooperation and the performance of various tasks before and after surgery, including performing MRI's, answering pain questioners, and neuropsychological evaluations.

Exclusion Criteria:

* Refusal to participate
* Pregnant women
Observational GORE® VIABAHN® Endoprosthesis With PROPATEN Bioactive Surface Global Registry

Collect real-world post-market clinical follow-up data on patients treated with the GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface (VSX)

This is an Observational, prospective, single-arm, multicenter, post-market registry to collect real-world post-market clinical follow-up data on patients treated with the GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface (VSX) for one of the following indications: Iliac, Superficial Femoral Artery (SFA), Superficial Femoral Artery In-stent restenosis (SFA ISR), Hemodialysis access (AV access), Visceral artery aneurysms (VAA), Trauma/Injury, Popliteal Artery Aneurysms (PAA), or Other. Approximately 35 sites in Europe will participate and a minimum of 614 patients will be enrolled in this registry. All consecutive patients meeting protocol selection criteria, consented, with an intention to be treated with the GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface (VSX) will be included and followed through one year for Trauma/Injury and other; three years for VAA; five years for Iliac, SFA, SFA ISR and AV access and ten years for PAA per institutional standard of care.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years
2. Signed informed consent form
3. Suitable for endovascular treatment with VSX based on treating physician's best medical judgment
4. Willingness of the patient to adhere to institutional standard of care follow-up requirements

Exclusion Criteria:

1. Non-compliant lesions where full expansion of an angioplasty balloon catheter is not achievable during pre-dilatation, or where lesions cannot be dilated sufficiently to allow passage of the delivery system.
2. Use of the VSX Device in lesions involving a major side branch that may be covered by the endoprosthesis.
3. Lesion(s) cannot be treated with available VSX Device sizes per current Instructions for Use (IFU).
4. Lesion requires treatment with an altered endoprosthesis or delivery system. (Do not cut the endoprosthesis. The endoprosthesis should only be placed and deployed using the supplied catheter system).
5. Previous or concurrent enrollment into this registry (e.g., previous enrollment into another treatment cohort or patient requires enrollment into more than one cohort) (Note: Only the first VSX treatment will be enrolled if concurrent VSX procedures are performed that would require enrollment into more than one cohort).
6. Participation in concurrent research study or registry which may confound registry results, unless approved by Gore.
7. Known hypersensitivity to heparin or a previous incident of Heparin-Induced Thrombocytopenia (HIT) type II.
8. Unable to tolerate antiplatelet therapy.
9. Patient has a non-controllable allergy to contrast or the VSX Device components.
10. Pregnant or breast-feeding female at time of informed consent signature.
11. Life expectancy \< 12 months due to comorbidities.
12. Patient has other medical conditions which, as determined by the investigator, may confound the data interpretation (e.g., sepsis, thrombophilic diseases, connective tissue disorders).
Effect on Kidney Function Recovery Guiding Decongestion With VExUS in Patients With Cardiorenal Syndrome 1

During cardiorenal syndrome type 1 (CRS1) vascular congestion is the major contributor to worsening renal function, but promoting decongestion with routine clinical evaluation is ineffective in some patients. The venous evaluation by ultrasound (VExUS) may optimize its management when evaluating for improvement in kidney function and other metrics related to decongestion.

Background: In cardiorenal syndrome type 1 (CRS1) vascular congestion is a common complication, the Venus Evaluation by Ultrasound System (VExUS) could guide decongestion effectively and thereby improve kidney function outcomes.

Methods: In this double-blind randomized clinical trial, patients with CRS1 were randomized to guide decongestion with VExUS compared to usual clinical evaluation. The primary and secondary endpoint was to assess kidney function recovery (KFR), days of hospitalization, mortality, changes in brain natriuretic peptide (BNP) and CA-125. Protocol register HCG/CEI-0836/22.

Eligibility Criteria:
Inclusion Criteria:

* Cardiorenal Syndrome type 1

Exclusion Criteria:

* kidney transplantation, chronic kidney disease (CKD) grade 4 or 5, dialysis and pregnancy. CKD was defined according to the KDIGO guidelines
Use of TrachPhone in Tracheostomized Patients

The use of Heat and Moisture Exchangers (HMEs) and their positive impact on pulmonary health have been extensively studied in patients with head and neck cancer but have not been systematically explored in other patient populations breathing through a neck stoma.

The objective of this clinical investigation is to compare the use of HMEs to the use of External Humidifiers (EHs) on pulmonary secretion management, their usability and safety, for humidifying inhaled air in patients that received a tracheostomy due to a neurological condition.


Eligibility Criteria:
Inclusion Criteria:

* Tracheostomy patient outside critical care
* Self-ventilating via a tracheostomy tube, independent of cuff status
* 18 years or older

Exclusion Criteria:

* Patients with tidal volume beyond recommended range (50-1000 ml)
* Dehydration
* Very heavy/excessive secretion from the lungs and airways (requiring more frequently tracheal suction, more than hourly suctioning)
* High oxygen need (FiO2 \> 0.4)
* Acutely deteriorating patient
Memantine Versus Placebo in Parkinson's Disease Dementia or Dementia With Lewy Bodies

The purpose of this exploratory study is to determine whether memantine can provide benefits on clinical symptoms in patients with Parkinson's Disease Dementia or Dementia with Lewy Bodies.

The objective of this exploratory study is to assess the benefits of memantine compared to placebo in out-patients with a diagnosis of Parkinson's Disease Dementia or Dementia with Lewy Bodies (mild to moderate severity) over a 6-month period. This is a multinational, randomised, double-blind, parallel-group, placebo-controlled, fixed-dose study with specific cognitive (attention, executive function, visual perception and memory), behavioural, functional and global measures.

Eligibility Criteria:
Inclusion Criteria:

* The study population will consist of male or female outpatients at least 50 years of age with mild to moderate disease severity (MMSE 12 to 24 inclusive) according to UKPDS and DSM IV TR criteria (for PDD patients) and the third report of the DLB consortium (for DLB patients) and who have a knowledgeable and reliable caregiver to accompany the patient to all clinic visits during the course of the study.

Exclusion Criteria:

* Evidence of clinically significant active disease, evidence of other neurological disorders, and current treatment with AChEIs.
Neuromodulation of Lidocaine Cream Effect on Chronic Pain Patients

Chronic low back pain patients aged 21 to 60 needed for a research study of the effects of transcranial direct current stimulation (tDCS) on the analgesic effects of lidocaine cream as measured by functional Magnetic Resonance Imaging (fMRI). Study will be conducted on nine separate days not requiring an overnight stay in the hospital.


Eligibility Criteria:
Inclusion Criteria:

* Volunteers 21-60 years of age.
* Meets the Classification Criteria of chronic LBP (having low back pain for more than 6 months), as determined by the referring physician.
* At least 4/10 clinical pain on the 11-point LBP VAS (criteria recommended by Dworkin et al.)
* At least a 10th grade English-reading level; English can be a second language provided that the patients understand all questions used in the assessment measures.

Exclusion Criteria:

* Specific causes of back pain (e.g., cancer, fractures, spinal stenosis, infections).
* Complicated back problems (e.g., prior back surgery, medicolegal issues).
* The intent to undergo surgery during the time of involvement in the study.
* History of cardiac, respiratory, or nervous system disease that, in the investigator's judgment, precludes participation in the study because of a heightened potential for adverse outcome. For example: asthma, claustrophobia, epilepsy or acute eczema under the electrodes.
* Presence of any contraindications to MRI scanning. For example: cardiac pacemaker, metal implants, claustrophobia, pregnancy, cannot lie still in an fMRI scanner.
* History of medical or psychiatric illness.
* History of substance / alcohol abuse or dependence.
Lumbar Transforaminal Epidural Dexamethasone

The aim of this study is to assess the effectiveness and safety of dexamethasone for transforaminal epidural steroid injection. A secondary aim of this study is to obtain data on the lowest most effective dose of dexamethasone for this treatment and the effective duration of effect.

Transforaminal epidural steroid injections (TFESI) have been demonstrated to be an effective treatment for radicular pain. Over the last decade, rare but serious complications have been reported following transforaminal epidural steroid injections (TFESI). Recent research indicates that certain types of corticosteroids containing microscopic particles may be responsible for these adverse events. Dexamethasone (DXM) is a non-particulate cortico-steroid that has not been implicated in these adverse events. However, there is inadequate evidence up to date to support the use of Dexamethasone (DXM) for transforaminal epidural steroid injections (TFESI). This study aims to bridge that gap.

Eligibility Criteria:
Inclusion Criteria:

* adults age 18 years and older, unilateral lumbar radicular pain, baseline distal radicular lower extremity pain VAS score ≥ 5/10, and prior favorable response to TFESI

Exclusion Criteria:

* pregnancy, infection, coagulopathy, uncontrolled diabetes mellitus, history of allergy to iodinated contrast medium and interventional therapies for pain within 90 days prior to study enrollment
Assessment of the Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type

This study was conducted to evaluate the efficacy, safety, and tolerability of AVP-786 (deudextromethorphan hydrobromide \[d6-DM\]/quinidine sulfate \[Q\]) compared to placebo for the treatment of agitation in participants with dementia of the Alzheimer's type.

Eligible participants for this study had a diagnosis of probable Alzheimer's disease (AD) and had clinically significant, moderate/severe agitation secondary to AD.

This was a multicenter, randomized, double-blind, placebo-controlled study, consisting of 12 weeks of treatment. Screening occurred within 4 weeks prior to randomization. Following screening procedures for assessment of inclusion and exclusion criteria, eligible participants were randomized into the study.

184 participants were enrolled into the study.

Study medication was administered orally twice daily from Day 1 through Day 85.

Eligibility Criteria:
Inclusion Criteria:

* Participants with a diagnosis of probable Alzheimer's disease according to the 2011 Neuropsychiatric Inventory Agitation/Aggression (NPI-AA) working groups criteria
* Participants with clinically significant, moderate-to-severe agitation for at least 2 weeks prior to Screening that interferes with daily routine per the Investigator's judgment
* Participants who require pharmacotherapy for the treatment of agitation per the Investigator's judgment after an evaluation of reversible factors and a course of nonpharmacological interventions
* Diagnosis of agitation must meet the International Psychogeriatric Association (IPA) provisional definition of agitation.
* Participants meeting an additional predetermined blinded eligibility criterion, which will remain blinded to the clinical study site Investigators and staff
* Participants with a reliable caregiver who is able and willing to comply with all study procedures, including adherence to administering study drug and not administering any prohibited medications during the course of the study, and who spends a minimum of 2 hours per day for 4 days per week with the participant

Exclusion Criteria:

* Participants with dementia predominantly of the non-Alzheimer's type (e.g., vascular dementia, frontotemporal dementia, Parkinson's disease, substance-induced dementia)
* Participants with symptoms of agitation that are not secondary to Alzheimer's dementia (e.g., secondary to pain, other psychiatric disorder, or delirium)
* Participants with co-existent clinically significant or unstable systemic diseases that could confound the interpretation of the safety results of the study (e.g., malignancy \[except skin basal-cell carcinoma\], poorly controlled diabetes, poorly controlled hypertension, unstable pulmonary, renal or hepatic disease, unstable ischemic cardiac disease, dilated cardiomyopathy, or unstable valvular heart disease)
* Participants with myasthenia gravis
Prospective Health Assessment of Cataract Patients' Ocular Surface

This study will determine the incidence and severity of dry eye in patients undergoing cataract surgery as determined by grade on the International Task Force (ITF) scale.


Eligibility Criteria:
Inclusion Criteria:

* Patients should be at least 55 years old.
* Patients must be scheduled to undergo cataract surgery.

Exclusion Criteria:

* No previous intraocular surgery in the previous 3 months in either eye.
* No previous Corneal laser vision correction in either eye within the last one year.
* No previous lid surgery within the past 3 months.
* Patients may not have used topical antibiotics, topical NSAIDs or topical steroid in either eye in the past month.
* Patients are not eligible if they have recently been started on Restasis solely as a perioperative treatment regimen.
* Patients presently using Restasis in either eye will not undergo any of the study testing but a questionnaire should be completed for these patients regarding use of these medications.
Evaluation of AI Cost Prediction Model to Enroll Patients in Complex Care Management Program

Currently, UCLA Health (specifically the Office of Population Health and Accountable Care, or OPHAC) runs a complex care management program called Proactive Care (goal is to reduce care utilization by providing personalized care navigation/case management). Every month, an AI Population Risk tool runs to identify around 250 of the 480,000 or so UCLA primary care patients, and RNs contact these 250 patients to enroll in Proactive Care. Starting in December 2024, OPHAC launched a new method of enrolling UCLA's Medicare Advantage (MA) patients into Proactive Care: an AI Cost Prediction model. The idea is the same-- the top 250 highest predicted cost patients will be enrolled in Proactive Care. The investigators will evaluate this model and subsequent enrollment into the program by randomizing the waitlist of MA patients waiting to enroll in Proactive Care, thereby creating a control group. The top 500 highest predicted cost patients will be identified each month, and following a 1:1 randomization, 250 will be contacted for enrollment and the rest will be put on a wait-list control group for 10 months unless otherwise requested by their provider to be enrolled in the Proactive Care program earlier.


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age
* Enrolled in a UCLA Managed Care Plan
* Cost prediction model identifies patient as having high predicted costs over the next 12 months

Exclusion Criteria:

* Currently enrolled in any UCLA care management program
* Enrolled in any UCLA care management program in the last 12 months
* Already has an active referral to a care management program
Randomized Trial of Two Ablation Catheters in Paroxysmal Atrial Fibrillation

Atrial fibrillation (AF) is a chaotic heart rhythm of the top chambers of the heart. AF occurs in up to 10% of the population over the age of 60. It is associated with tiredness, impaired functional capacity and is the cause of up to 10% of strokes.

Ablation is a procedure performed with small tubes (catheters) that are introduced through the top of the leg. Burns are made inside of the heart to treat AF. This procedure has been shown to cure 90% of patients with intermittent (paroxysmal) AF.

The investigators currently use either one of two different catheters to create these burns inside the heart. The investigators do not know which is the best catheter to use in patients with paroxysmal atrial fibrillation.

The investigators study will randomly allocate patients to have their ablation performed by either one of the catheters to give a fair comparison between the two. The investigators objective is to study the differences between these two catheters.


Eligibility Criteria:
Inclusion Criteria:

* Patients with paroxysmal AF with a planned ablation procedure

Exclusion Criteria:

* Prior AF ablation
* LA size greater than 60mm
* Mechanical prosthetic MVR
* Hypertrophic cardiomyopathy
A Phase II, Open-Label Study of Clofarabine in Paediatric Patients With Refractory/Relapsed Acute Lymphoblastic Leukaemia

This study is for a population of patients with few or no alternative options that was conducted to determine the response rate to clofarabine. Additionally the study will provide information on the safety profile, impact of overall survival, and impact on remission duration with clofarabine. It is a single arm study and has no comparator.

Note: This clinical trial was conducted by Bioenvision Ltd. Bioenvision Ltd. was acquired by Genzyme Corporation Oct 2007.

Eligibility Criteria:
Inclusion Criteria:

* Have a diagnosis of ALL and confirmed by pathologic assessment.
* Be ≤ 21 years old at time of initial diagnosis.
* Eligible patients must have: Primary refractory disease; OR relapsed or refractory disease after a minimum of 2 prior blocks of treatment.
* Must not be eligible for therapy of higher curative potential.
* Have a Karnofsky Performance Status of ≥ 50 or Lansky Performance Scale of ≥ 30.
* Provide a signed, written informed consent from parent or guardian or young adult patients.
* Be able to comply with study procedures and follow-up examinations.
* Have adequate cardiac function without treatment.
* Have adequate organ function as indicated by the laboratory values for serum creatinine, serum bilirubin, AST and ALT, obtained within 7 days prior to registration.

Exclusion Criteria:

* Received previous treatment with clofarabine.
* Patients with isolated extramedullary disease.
* Have received prior BMT or PBSCT within the last 6 months.
* Have received prior BMT or PBSCT more than 6 months ago, but now has compromised organ function.
* Have an active, uncontrolled systemic infection.
* Are pregnant or lactating. Male and female patients who are fertile must agree to use an effective means of birth control to avoid pregnancy.
* Have a psychiatric disorder that would interfere with consent, study participation, or follow-up.
* Have received any other chemotherapy within the previous 2 weeks and must have recovered from acute toxicity oa all previous therapy prior to enrollment.
* Have any other severe concurrent disease.
* Have recent history of significant renal, hepatic or pulmonary dysfunction, or cardiac dysfunction or on treatment to support cardiac function.
* Have CNS disease.