cyrilzakka/clinical-trials huggingface dataset:
The Fusion Versus The Affinity Oxygenation Systems

This study compares between the clinical, hematological, inflammatory and neurological outcome of patients undergoing Coronary Artery Bypass Grafting (CABG) surgery in which different oxygenation systems will be used.

In order to assess the efficacy and safety of fusion Oxygenation System in patients undergoing isolated CABG, a prospective one-to-one randomized trial comparing the fusion oxygenation to the currently used affinity oxygenation system will be conducted. Forty patients intending to undergo CABG will be divided into 2 groups according to the oxygenation system which will be used during surgery. Distribution into groups will be done randomly. Ten patients undergoing elective peripheral vascular surgical procedures under general anesthesia and 10 patients undergoing elective percutaneous coronary intervention will serve as control groups for the neurological outcomes. Clinical status, inflammatory and hematological response as well as Neurological outcome will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (18-75 years old) undergoing first-time, isolated CABG at the Hebrew University, Hadassah Medical Center, Jerusalem, Israel and the University Hospital of Angers, Angers, France.
* Patients undergoing elective peripheral vascular surgical procedures under general anesthesia
* Patients undergoing elective percutaneous coronary intervention will serve as control groups

Exclusion Criteria:

* Emergency operations
* Left ventricular ejection fraction less than 30%
* CABG with concomitant procedure
* Previous stroke or documented neurological disorder
* High grade (\>70%) unilateral or bilateral carotid stenosis
* Contraindication to MRI testing.
Novel Preventive Approach Against Filgrastim-Induced Bone Pain in Cancer Patients

No randomized controlled trial evaluated the safety and efficacy of double blockade on G-CSF induced bone pain. Therefore, this study aims to evaluate the efficacy and safety of double blockade on the incidence and severity of G-CSF induced bone pain.


Eligibility Criteria:
Inclusion Criteria:

1. Eligible patients were 18 years or older.
2. Confirmed diagnosis of breast cancer.
3. Patients completed adriamycin and cyclophosphamide (AC) regimen and are planned to receive four cycles or more of paclitaxel chemotherapy with G-CSF support starting in cycle 1 and continuing throughout each of the four paclitaxel cycles.
4. Eastern Cooperative Oncology Group (ECOG) performance status from 0 to 2.

Exclusion Criteria:

1. Patients with signs and symptoms of grade 2 or 3 bone pain at baseline.
2. Patients receiving famotidine in the previous 72 hours.
3. Patient receiving any antihistaminic in the previous 72 hours.
4. Hypersensitivity to famotidine or loratadine.
5. Patient receiving opioid or adjuvant analgesic.
A Randomized Control Trial of Patient-initiated Hospital Follow-up for Patients With Psoriasis

The primary objective of this research protocol is to evaluate the health related quality of life and efficacy of patient-initiated hospital follow-up for patients with moderate to severe psoriasis.

Psoriasis is a chronic inflammatory skin disease affecting 1 to 3% of the European population. Treatment of moderate to severe psoriasis often requires lifetime routine reviews by hospital dermatologist. Patterns of hospital review vary, but most patients attend follow-up every 12-16 week by dermatologist. At routine reviews the patient disease is often quiet and little intervention or no intervention is required, and times were the patient need help the time is limited for in-depth consultation. Both patient and healthcare professional requested more time. In-depth consultation is important in the care of psoriasis, because moderate to severe psoriasis has a significant impact on quality of life and patient have an increased incidence of cardiovascular risk factors such as hypertension, overweight, hyperlipidemia and exposure to tobacco and alcohol. These comorbidities and the psychosocial burden must be addressed by clinicians to help patients to acquire or to maintain competencies that are required to live with a chronic disease.

Patient-initiated hospital follow-up for patients with moderate to severe psoriasis might reduce inappropriate follow-up appointments, improve rapid access to specialist care and release resource to further in-depth consultation. If the patient is empowered to initiate hospital review thus patient's individual needs dictate the content, duration and contact with clinicians. It is our goal that an individual needs-based patient involvement in the shape of patient-initiated hospital follow-up,will be perceived as a benefit of the patients who 1) meets a high safety in the patient's own provision of medical treatment, 2) increase the patient's knowledge of the lifestyle and prevention of comorbidities and 3) strengths patient's overall satisfaction with treatment.

Eligibility Criteria:
Inclusion Criteria:

• Patients in stable systemic psoriasis treatment defined as having received treatment for more then 12 weeks without complication and being adherence to medication administration.

Exclusion Criteria:

* Patients not able to give informed consent
* Patients not able to follow the program
* Patient with server psychiatric diseases
Effect of Omega-3 Supplementation on Serum Level and Gene Expression of IGF-1and IGFBP-3 in Men With CVD.

The aim of this study is the comparison between the effects of supplementation with omega 3 or placebo for 8 weeks in serum level of IGF-1 and IGFBP-3 and gene expression of IGF-1 in patients with cardiovascular disease.


Eligibility Criteria:
Inclusion Criteria:

* CVD patients 45- 65 years old, patients with ≥ 50% stenosis in at least one coronary angiogram demonstrated, body mass index in the range 18.5- 35, avoidance of dietary supplements, vitamins and herbal products at least 3 months before and throughout the intervention, willingness to participation,

Exclusion Criteria:

* people who have used omega 3 supplements in last 3 months, having chronic renal disease , GI disease, hepatobiliary diseases, hematological disorders, hypo- or hyperthyroidism, Smokers
Effect of Body Position on Hemodynamics in Patients With Acute Ischemic Stroke Undergoing Ultra-early Reperfusion Therapy

The aim of this study was to determine the differences in hemodynamics between different positions in patients undergoing ultra-early reperfusion therapy.

Hemodynamic stability can prevent hypoperfusion or hyperperfusion after reperfusion therapy. It has been reported in a large number of literatures that body position has an effect on hemodynamics, but the effect of different body positions on the hemodynamics of patients undergoing ultra-early reperfusion therapy is not clear. In this study, we hypothesized that the hemodynamics of patients undergoing ultra-early reperfusion therapy would differ between different positions.

Eligibility Criteria:
Inclusion Criteria:

* Age≥18 years, \< 80 years, regardless of sex；
* Patients with clinically confirmed acute ischemic stroke who received intravenous thrombolysis or emergency endovascular treatment;
* Baseline National Institute of Health stroke scale（NIHSS）score ≤25;
* Baseline Glasgow Coma Scale (GCS) ≥8;
* Signed and dated informed consent is obtained

Exclusion Criteria:

* The patient has clear indications or contraindications, such as active vomiting, spinal cord injury；
* Clinicians considered that the assigned body position could not be maintained; Patients unable to cooperate with all noninvasive beat-by-beat continuous BP monitoring;
* Poor temporal window penetration;
* Patients with diseases that seriously affect hemodynamics, such as atrial fibrillation, anemia, and hyperthyroidism;
* Previous history of atrial fibrillation or ECG showing atrial fibrillation or arrhythmia;
* Pregnant or lactating women;
* Poor treatment compliance;
* Complicated with severe systemic diseases, such as heart failure, respiratory failure, renal failure, gastrointestinal bleeding, coagulopathy, malignant tumors.
Mangafodipir as an Adjunct to Percutaneous Coronary Intervention

The present feasibility study is designed to find out whether pre-treatment with the compound mangafodipir (PP-099) provides an additional reduction in myocardial infarct size in patients treated with primary percutaneous coronary intervention (PCI) during acute myocardial infarction (AMI).

Mangafodipir, manganese (Mn) dipyridoxyl diphosphate (MnDPDP) and its lipophile metabolite Mn dipyridoxyl diethylene diamide (MnPLED), are catalytic antioxidants and iron chelators. In preclinical studies these agents reduce oxidative stress induced injuries related to chemotherapy of cancer and to reperfusion/reoxygenation of ischemic/hypoxic myocardium. Accordingly, in an in vivo pig model of AMI metabolite MnPLED applied at end of ischemia and during reperfusion reduced myocardial infarct size by 55 %. Mangafodipir most likely activates salvage pathways and prevents lethal reperfusion injuries.

Other advantages are that mangafodipir is already approved as a contrast agent for MRI of liver, and that the experience for more than a decade reveals a high safety with minor and tolerable side-effects.

The present study will include 20 patients treated for their first documented AMI. They will after admission to hospital undergo primary PCI. Reopening of an occluded coronary artery will be preceded by iv. infusion of mangafodipir or placebo in two groups , each consisting of 10 patients. The primary endpoint will be release to plasma of commonly accepted biomarkers of myocardial injury (Troponin T and CK-MB) measured at admission and 6 hours after PCI. The secondary endpoints include the accumulated release of plasma biomarkers over 48 hours and direct measurement of the final myocardial infarct size at 6-10 weeks after PCI.

Eligibility Criteria:
Inclusion Criteria:

1. Males 40-80 and females 50-80 years with first severe coronary attack
2. Chest pain up to 6 hours.
3. T segment elevation (≥ 0.2 mV in two neighbouring anterior and inferior wall leads.
4. Decided for treatment by primary PCI.
5. TIMI grade 0 flow in the occluded LAD or RCA artery
6. Written informed consent.

Exclusion Criteria:

1. Previous coronary artery bypass operation.
2. Previous AMI.
3. Chest pain more than 6 hours.
4. Angina within 48 hours before admission.
5. Cardiac arrest and cardiogenic shock.
6. Occlusion of the left main stem, circumflex and right coronary arteries at angiography.
7. Known hypersensitivity to mangafodipir (as contrast agent for MRI).
8. Received mangafodipir ≤ 5 weeks before admission
9. History of prior serious allergic or pseudo-allergic reaction
10. Severely reduced liver or renal function
11. Any other serious illness or medical condition
12. Fertile females
13. Phaeochromocytoma
Resolving the Burden of Low Back Pain in Military Service Members and Veterans: A Pragmatic Clinical Trial

The RESOLVE trial will provide a pragmatic approach to evaluate whether Physical Therapy Clinical Practice Guideline adherence can reduce pain, disability and downstream healthcare utilization for low back pain within the Departments of Defense and Veterans Affairs healthcare systems.

Physical therapy (PT) is frequently used for the management of low back pain (LBP) within the U.S. Departments of Defense (DoD) and Veterans Affairs (VA). However, variations in PT practice patterns and utilization of ineffective interventions lower the quality and increase the cost of care. Although, adherence to the clinical practice guidelines (CPGs) can improve outcomes and cost effectiveness of LBP care, PT CPG adherence rates remain below 50%. The RESOLVE trial will evaluate the effectiveness of an active PT CPG implementation strategy using an education/audit/feedback model for reducing pain, disability, medication use and cost of LBP care within the DoD and VA healthcare systems. The RESOLVE trial will include 3300 to 7260 patients with LBP from five DoD and VA medical facilities, using a stepped-wedge study design. An education/audit/feedback model will be used to encourage the physical therapists to better adhere to the PT CPG recommendations. The primary outcomes of disability and pain intensity will be measured with the Oswestry Disability Index and the Defense and Veterans Pain Rating Scale. Secondary outcomes will include the LBP-related medical resource utilization and biopsychosocial predictors of PT outcomes. Statistical analyses will be based on intention to treat principles and will use linear mixed models to compare treatment conditions, and examine the interactions between treatment and sub-grouping status. The RESOLVE trial will provide a pragmatic approach to evaluate whether PT CPG adherence can reduce pain, disability and downstream healthcare utilization for LBP within the DoD and VA healthcare systems.

Eligibility Criteria:
Inclusion Criteria:

* Receiving physical therapy care for low back pain in an outpatient physical therapy setting
Personalised Real-time Interoperable Sepsis Monitoring (PRISM)

The goal of this prospective observational study is to develop and utilize an Artificial Intelligence (AI) model for the prediction of postoperative sepsis in patients undergoing abdominal surgery. The main questions it aims to answer are:

1. Can a remote AI-driven monitoring system accurately predict sepsis risk in postoperative patients?
2. How effectively can this system integrate and analyze multimodal data for early sepsis detection in the surgical ward?

Participants are equipped with non-invasive PPG-based wearable devices to continuously monitor vital signs and collect high-quality clinical data. This data, along with demographic and laboratory information from the Electronic Health Record (EHR) of the hospital, are used for AI model development and validation.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing elective abdominal surgery.
* Postoperative admission to the surgical ward.
* Age 18 years or older, who are able and willing to participate and have given written consent.
* On admission, the primary investigator assess their risk to deteriorate during the first 72 hours after admission as reasonably high.

Exclusion Criteria:

* \<18 years of age Known allergy or contraindication to the monitoring devices.
* Pre-existing conditions that could interfere with the study (e.g., chronic sepsis, immunodeficiency disorders).
* Day case surgery.
* Pregnancy.
* Immediate transfer to ICU postoperatively.
* Patient refusal or unable to give written consent.
Potassium Citrate and Crystal Light Lemonade

To define the effect of crystal light, potassium citrate, or both on urinary stone risk factors in patients with a history of stone and hypocitraturia/low pH


Eligibility Criteria:
Inclusion Criteria:

1. Men and women between age 18-80 years
2. Willing to follow experimental protocol
3. Willing to complete 24-hour urine collections (three total)
4. Willing to sign the informed consent form
5. Completed Litholink Collection with blood work with results

   a. hypocitraturia OR aciduria i. Hypocitraturics must meet definition of \< 450 mg/day for men \< 550 mg/day for women.

   b. Low urine pH must be less than 5.6 c. potassium, BUN, creatinine, eGFR and hemoglobin A1c within normal limits

Exclusion Criteria:

1. Patients with severe hypocitraturia \< 200 mg/day (men or women)
2. Patients with hyperkalemia, uncontrolled diabetes, chronic kidney disease, adrenal insufficiency, delayed gastric emptying (or drug induced delayed gastric emptying), peptic ulcer disease, or active UTI
3. Patients with distal renal tubular acidosis or medication induced RTA (e.g. carbonic anhydrase inhibitor, topiramate)
4. Members of vulnerable patient populations
5. Allergies to ingredients in crystal light
6. Patients lacking decisional capacity
Safety of Negative FrActional Flow Reserve in Patients With ChallEnging Lesions

Fractional Flow Reserve (FFR) has recently emerged and has been largely validated as a safe and efficacious way of ischemia testing for patients with stable angina. The new recently ESC guidelines have strongly suggested a FFR based approach for patients with stable angina, also for those with challenging lesions like left main disease, severe multivessel stenosis for heart failure patients and those with single remaining vessels although left main disease and an ejection fraction less than 30% are exclusion criteria of the randomized controlled trials on this topic. Consequently the investigators performed a prospective multicenter study to understand the safety and efficacy of a FFR based approach for these patients.

The present is a multicenter prospective study enrolling all patients with stable angina and/or documented ischemia presenting with:

* An angiographic stenosis of more than 50% and less than 90% of the left main
* Any proximal descending anterior with a stenosis of more than 50% and less than 90%
* Two or three vessel disease with a stenosis of more than 50% and less than 90% and a left ventricle ejection fraction less than 40%
* Single remaining patent coronary artery with stenosis \>50% and less than 90%

In all of these patients FFR (Fractional Flow Reserve) will be performed according to guidelines and stenting will be performed or deferred according to the result of this test. Other techniques, like iFR, IVUS and OCT will be left at the operators' choice and will be recorded. MACE (a composite end point of death, myocardial infarction and target vessel revascularization and stent thrombosis) will be the primary end point, while its single components will be the secondary ones.

Eligibility Criteria:
Inclusion Criteria:

* An angiographic stenosis of more than 50% and less than 90% of the left main
* Any proximal descending anterior with a stenosis of more than 50% and less than 90%
* Two or three vessel disease with a stenosis of more than 50% and less than 90% and a left ventricle ejection fraction less than 40%
* Single remaining patent coronary artery with stenosis \>50% and less than 90%

Exclusion Criteria:

* Severe aortic stenosis
Study to Assess the Absorption, Distribution, Metabolism and Excretion of AZD1656 in Type 2 Diabetes Mellitus (T2DM)

The purpose of the study is to evaluate the absorption, distribution, metabolism and excretion of AZD1656 after administration of a single oral dose of 14C-labelled AZD1656 solution in male Type 2 Diabetes Mellitus patients.


Eligibility Criteria:
Inclusion Criteria:

* Male type II diabetes patients diagnosed for more than 5 years and aged between 35 and 65 years.
* Subjects treated with metformin alone or metformin and one other oral anti-diabetic drug.
* Subjects should have FPG in the range of 6.0 to 11.0 mmol/L at screening and HbA1c less than 10% (HbA1c value according to international DCCT standard).

Exclusion Criteria:

* History of ischemic heart disease, stroke, transient ischemic attack or symptomatic peripheral vascular disease.
* Renal dysfunction.
* Use of insulin, glitazones, warfarin and amiodarone within 3 months before enrolment and use of potent CYP450 inhibitors, e.g., ketoconazole and macrolide antibiotics within 14 days before administration of IP.
Attentional Training for Smoking Cessation Via Handheld Device or Personal Computer

Several studies indicate that cigarette smokers show an attentional bias for cigarette-related cues, meaning that they more quickly detect and attend to and have more difficulty disengaging in cigarette-related information than neutral information. This bias is associated with craving and relapse following attempts to quit. This experiment will examine whether a computerized attentional training procedure will successfully reduce attentional bias towards smoking cues and reduce craving in regular cigarette smokers. The attentional training will be administered in a novel format in which participants complete 5-minute long training sessions 3 times per day and can complete the trainings via home computer or handheld device such as the iPhone, Android phone, or iPod touch. A baseline assessment in the laboratory will measure attentional bias to smoking cues and craving following smoking cue exposure. Participants will then be randomly assigned to either the active training condition or a control condition. In both conditions, participants will be asked to complete brief training sessions 3 times daily for one week using their personal computer or handheld device. Following one week of training, participants will return to the lab for endpoint assessment of attentional bias and craving. The investigators hypothesize that compared to the control condition, the active training condition will significantly reduce attentional bias toward smoking related cues and cue-induced cigarette craving.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18-65.
2. Familiarity with a computer keyboard and mouse.
3. Must own a iPhone, iPod Touch, or Google Android-based phone (such as the Droid or Nexus One) or have regular access to the Internet via personal computer.
4. Current regular smoker, as defined by self-reported use of at least 1 year and a current average of at least 10 cigarettes smoked per day.

Exclusion Criteria:

1. Individuals with current suicidality (determined by a score of 2 or 3 on item 9 of the Beck Depression Inventory given following consent) will be excluded from further participation.
Clinical Impact of Cytokine in Cardiac Surgery

Cardiac surgery leeds to a systematic inflammatory response induced by the surgical trauma and the use of the cardiopulmonary bypass (CPB). Activation of inflammatory cascades can cause a systemic inflammatory response syndrome (SIRS) which is associated with increased morbidity and mortality. Therefore, strategies to reduce the inflammatory response have a potential benefit for cardiac surgery patients.

The clinical benefit of reducing proinflammatory cytokines such as IL-6, Il-8 and TNF-a with the use of a cytokine adsorbing circuit (Cytosorb) during CBP remains unclear. Therefore, the investigators conduct this prospective, observational pilot study to determine the clinical impact of the use of a cytokine adsorbing circuit during CBP.

Patients, who have an elective myocardial revascularization and give there written consent will be enrolled to the study. Demographic, intraoperative, and postoperative data will be collected prospectively. Furthermore, blood samples (1. before induction of anaesthesia 2. at the end of CPB 3. 6 hours after surgery 4. 24 hours after surgery 5. 3-5 days after surgery) will be analyzed.

Eligibility Criteria:
Inclusion Criteria:

* • Elective myocardial revascularization

Exclusion Criteria:

* Emergency procedures
* Declined informed consent
* Body mass index \< 18
* Age \< 18 years
* Pregnant women
* Receiving chemotherapy
* Diagnosed with any disease state (e.g., AIDS) that has produced leukopenia
* Receiving antileukocyte drugs
* Receiving TNF-α Blockers
* Receiving immunosuppressive drugs or hormone therapy (e.g. tamoxifen)
* CRP \> 5 mg/dl